Best Practice & Research Clinical Obstetrics and Gynaecology Vol. 20, No. 6, pp.

953e975, 2006
doi:10.1016/j.bpobgyn.2006.06.004 available online at http://www.sciencedirect.com

8 Ambulatory hysteroscopy: evidence-based guide to diagnosis and therapy

Shagaf H. Bakour*
City Hospital, Birmingham, UK
MD, MRCOG

Consultant and Honorary Senior Lecturer in Obstetrics and Gynaecology

Sian E. Jones

MB, BCh, FRCOG

Consultant Gynaecologist Bradford Royal Inrmary, Bradford, UK

Peter ODonovan

MD, Bch, BAO, FRCS (Eng), FRCOG

Consultant Obstetrician & Gynaecologist Bradford Royal Inrmary, Bradford, UK

Healthcare providers are facing increasing demands for improvement in quality of life for patients. Improvements in service provision for women are being ensured by the introduction of minimally invasive technologies into all spheres of gynaecologic practice. Ambulatory hysteroscopy (direct endoscopic visualization of the endometrial cavity) is an extremely exciting and rapidly advancing eld of gynaecologic practice. It advanced dramatically during the 1990s, shifting the focus in healthcare away from inpatient diagnosis and treatment. Hysteroscopy is used extensively in the evaluation of common gynaecological problems that were previously evaluated with blind and inaccurate techniques (e.g. premenopausal menstrual disorders, infertility and postmenopausal bleeding). It allows direct visualization of the uterine cavity and the opportunity for targeted biopsy, safe removal of endometrial polyps, and treatment of submucous broids, septa and adhesions. Ambulatory hysteroscopy is safe, with a low incidence of serious complications; it has a small failure rate. There is a general consensus that hysteroscopy is the current gold standard for evaluating intrauterine pathology, including submucous myomas, polyps, hyperplasia and cancer. Hysteroscopy in the ambulatory setting appears to have an accuracy and patient acceptability equivalent to inpatient hysteroscopy under general anaesthetic. The primary goal of this chapter is to provide a high-quality, evidence-based text on ambulatory diagnostic and operative hysteroscopy. The chapter includes in-depth analysis of

* Corresponding author. Address: City Hospital, Birmingham, UK. Tel.: 44 121 554 3801x4377; Fax: 44 121 507 5467. E-mail address: shagaf.bakour@swbh.nhs.co.uk (S.H. Bakour). 1521-6934/$ - see front matter 2006 Published by Elsevier Ltd.

954 S. H. Bakour et al

the indications for outpatient hysteroscopy, its contraindications, the accuracy of diagnostic hysteroscopy, relevant risk management issues and, training and teaching. Keywords: advanced hysteroscopy training; ambulatory; diagnostic test accuracy; nurse hysteroscopy; one-stop clinic; outpatient diagnostic and operative hysteroscopy; risk management.

Questions and Literature Sources Questions  Population: women with abnormal uterine bleeding  Interventions: ambulatory diagnostic and operative hysteroscopy (coil retrieval, polypectomy, removal of submucous myoma, endometrial ablation, and sterilization)  Outcomes: feasibility, acceptability, success rate, effectiveness of therapeutic interventions with the impact on quality of womens life, and accuracy of the test against gold standards Literature sources  Electronic databases: relevant articles were identied through searches of the Cochrane Library, Best Evidence, MEDLINE, and EMBASE (1970e2005)  Manual search: of bibliographies of known primary and review articles, personal les of articles available from the authors and contact with experts and manufacturers

INTRODUCTION Historical background Pantaleoni performed the rst ambulatory diagnostic and operative hysteroscopy in 1869; he used a Desmoreaux cystoscope to diagnose and treat a haemorrhagic uterine growth with silver nitrate. The greatest subsequent improvements in distension media took place in the early 1970s, and in 1979 Hamou revolutionized the eld of hysteroscopy with improved visual optics and ne-diameter instruments (<4-mm hysteroscopes). The ability to examine conscious patients in the outpatient clinic further popularized hysteroscopy in the 1980s and 1990s. The need for outpatient hysteroscopy It is estimated that about a quarter of all women will complain of abnormal uterine bleeding (pre- or postmenopausal) at some time.1 Abnormal uterine bleeding can have a profound effect on a womans life; she can suffer socially, physically, psychologically and psychosexually. The aim of investigation is to exclude endometrial cancer, hyperplasia and benign lesions. Until recently, diagnosis and treatment involved lengthy multiple visits in both primary and secondary care, which meant a huge amount of disruption to the patients life, long waiting times and a high rate of major surgery.

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Today, women with abnormal uterine bleeding can be assessed in a dedicated (onestop) clinic and will receive prompt diagnosis and treatment. Waiting times are reduced as women are seen in one visit, which includes a consultation, ultrasound scan (if appropriate), outpatient hysteroscopy and endometrial sampling leading to an individualized management plan. One-stop clinics are usually staffed by a gynaecologist, although nurse specialists are now taking on this role. Since the 1990s, new hysteroscopes with a nal diameter of <5 mm have enabled diagnostic and operative hysteroscopy to be performed in the outpatient setting, without cervical dilatation and consequently without anaesthesia or analgesia. The advent of small mechanical instruments and bipolar electrosurgical technology enables hysteroscopic procedures to be performed in a see and treat fashion in an ambulatory setting. Advantages of a one-stop hysteroscopy clinic An ideal one-stop clinic is an outpatient, ambulatory, rapid-access, see-and-treat clinic. Recent randomized trials have shown that this approach is efcient and results in increased patient satisfaction.2e4 Patients benet from more rapid diagnosis and treatment and a speedier return to normal functioning and work; safety is improved because bipolar electrosurgery and mechanical instruments are safer than monopolar electrosurgery. Hospitals and clinicians welcome the opportunity to increase day-case rates and protect elective activity from erosion due to rising medical emergency admissions; the opportunity to run double clinic sessions with a nurse specialist is a further advantage. Ambulatory hysteroscopy The exible hysteroscope was developed to overcome difculties in viewing the cornual areas and in entering acutely anteverted and retroverted uterus. Flexible hysteroscopy has been shown to be associated with less pain than rigid hysteroscopy.5 Rigid telescopes are available in different angles of vision ranging from 0 to 30 degrees, the former being the most popular for ambulatory hysteroscopy. Their external diameters vary from 1.2 mm to 4 mm. The telescope is inserted into an examination sheath of 3e5 mm diameter. Versascope and Versapoint This innovation is very useful in ambulatory operative hysteroscopy. It can be used with physiological saline as a distension medium, thus reducing the chance of uid overload when compared with the use of hypotonic non-ionic media like glycine, sorbitol or mannitol when monopolar electrosurgery is used. Lateral thermal spread is less likely. Three electrode congurations are available: spring, twizzle and ball electrodes in addition to the Versapoint bipolar loop electrode. AMBULATORY HYSTEROSCOPIC NEW TECHNIQUE Consent: before performing hysteroscopy, seeking patients consent, either verbally or in writing, is an ethical obligation. Vaginoscopy: is an approach (without the use of speculum or tenaculum) that can eliminate patient discomfort related to the traditional approach. Vaginoscopy is easy

956 S. H. Bakour et al

to perform, incurs no additional cost and is ideal for ambulatory hysteroscopy in patients who might otherwise require general anaesthesia just because they cannot tolerate a vaginal speculum (e.g. virgins and older women with somewhat stenotic vaginas). If the vaginoscopic approach is used, the vaginal fornix, ectocervix, cervical canal and uterine cavity can all be explored. During examination of the ectocervix, low magnication provides an excellent view of the cervix, a step that should never be missed. Hysteroscopy As a general principle, the hysteroscope should always be the rst instrument to be inserted in the cervical canal. Histological specimens can be obtained either at the time of hysteroscopy (directed/target) or using a blind endometrial suction sampling device (e.g. Pipelle). Research has demonstrated that such sampling has a high degree of accuracy for diagnosis of endometrial cancer and hyperplasia.6 The failure rate for an ambulatory hysteroscopy varies between 2 and 8% in the literature (around 4%)4,7, which is not inferior to that of an inpatient procedure (3%). The failure rate of hysteroscopy in postmenopausal women is no higher than in premenopausal women.7 PAIN CONTROL IN OUTPATIENT HYSTEROSCOPY The aim of ambulatory hysteroscopy is to provide an effective investigation with minimal discomfort for the patient. Anatomic considerations The inferior hypogastric nerve plexus lies just lateral to the uterus and vagina in the uterosacral/cardinal ligament complex. This plexus contains sympathetic pelvic splanchnic nerves from the thoracolumbar trunk and parasympathetics from the craniosacral trunk. It has three portions: (1) the vesical anterior plexus; (2) the uterovaginal plexus (also known as Frankenhausers plexus); and (3) the middle rectal plexus. Frankenhausers plexus appears to innervate the lower part of the uterine body, the cervix and the upper vagina. It lies on the dorsomedial surface of the uterine vessels. The uterine vessels, within the cardinal ligaments, enter the cervix at the 3 and 9 oclock positions. An additional set of nerves is contained in the uterosacral complex; these nerves insert at the 4 and 8 oclock positions on the posterior aspect of the uterus. It is not clear whether the afferent pain bres from the uterine body run in Frankenhausers plexus or whether they are included in the neurovascular bundle of the infundibulopelvic ligament. Why hysteroscopy causes pain and discomfort Distension of the uterine cavity causes discomfort and pain. The lower the distension pressure in the uterus, the less the discomfort: a minimum of 30 mmHg is needed to separate the uterine walls. In the outpatient setting the pressure should be kept to this minimum. A prospective, randomized controlled trial (RCT) comparing carbon dioxide and normal saline for uterine distension in outpatient hysteroscopy found signicantly less abdominal pain and less shoulder tip pain with saline.8 Irrespective of the

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distension medium used, pelvic discomfort is worse in nulliparous women than in multiparous women.7 The size of the hysteroscope and sheath has an impact on pain and success rates. Diameters of <3.5 mm are well tolerated in the outpatient setting. The addition of endometrial biopsy to hysteroscopy increases pain.9 Menopause has no effect on the procedure being painful.7 Proper counselling before the procedure and talking to the patient during the procedure can improve tolerability. A well-trained healthcare assistant (HCA) is ideal for this role. Anaesthetic techniques for outpatient hysteroscopic procedures It is important to remember that the majority of outpatient diagnostic hysteroscopies do not need any anaesthesia or analgesia; this is required only if there is a need to overcome cervical stenosis, i.e. to dilate the cervix or during some outpatient operative hysteroscopic procedures. Polyps can be removed, or broids treated, with minimal pain using bipolar energy, snares or mechanical instruments without the need to dilate the cervix. The available anaesthetic techniques for outpatient hysteroscopic procedures include topical lidocaine or Instillagel, intrauterine lidocaine, the traditional paracervical block, and the deep paracervical block. Paracervical blocks The traditional paracervical block involves injecting of 1e2 mL local anaesthetic solution (prilocaine, Citanest R) supercially into the tenaculum site at 12 oclock. Then the cervix is gently grasped. Injections of 1e2 mL are used supercially to create blebs around the cervicovaginal mucosa; a total of 10 mL is used to create a ring around the cervix. A further 10 mL is injected deep into the lower uterine segment where the uterosacral ligaments attach (4-quadrant block). By pulling the cervix forward, one can see tenting at the ligament attachment. The paracervical block involves injecting deeply between 2 and 3 oclock and between 4 and 5 oclock on one side and then between 9 and 10 oclock and between 7 and 8 oclock on the other. Aspiration before injecting is essential. Less experienced clinicians often do not use deep paracervical block. Instead the injecting anaesthetic is placed at the cervicovaginal reection. Analgesia for hysteroscopy Analgesia, in the form of paracetamol or a non-steroidal anti-inammatory, can be used for ambulatory hysteroscopic operations. 100 mg of diclofenac sodium suppository 1 hour before the procedure has demonstrated high efcacy.10 This is particularly popular in ambulatory settings because of the simplicity of administration and low incidence of side-effects. Simple analgesics such as paracetamol orally 0.5e1 g every 4e6 hours to a maximum of 4 g daily might be added for analgesia post-hysteroscopy. INDICATIONS AND CONTRAINDICATIONS FOR AMBULATORY HYSTEROSCOPY Indications for ambulatory hysteroscopy  Evaluation of abnormal uterine bleeding.  Diagnosis and treatment of focal intrauterine lesions, e.g. polyps, broids.

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Investigation of infertility. Diagnosis and treatment of intrauterine adhesions. Diagnosis and treatment of uterine septa. Investigation of recurrent miscarriage. Location and retrieval of a lost intrauterine contraceptive device (IUD). Ablation of the endometrium. Hysteroscopic sterilization.

Abnormal uterine bleeding Abnormal uterine bleeding accounts for more than 20% of referrals to the gynaecologist and for 25% of gynaecologic procedures in premenstrual women.11 Abnormal uterine bleeding can be subdivided into premenopausal bleeding problems, postmenopausal bleeding and unscheduled bleeding on hormone replacement therapy or tamoxifen. When combined with pelvic transvaginal ultrasound and endometrial biopsy, outpatient hysteroscopy is invaluable in the investigation of abnormal uterine bleeding. Before considering hysteroscopy in all women of childbearing age, it is important to rule out pregnancy and pregnancy-related bleeding conditions; bleeding from use of hormonal preparations (oral contraception, contraceptive implants and injections); bleeding from complications of the use of intrauterine contraceptive devices; bleeding diathesis, e.g. von Willebrand disease and bleeding from infective causes, e.g. cervicitis, endometritis. Structural lesions responsible for abnormal uterine bleeding are often at their peak during the perimenopausal period; these include focal lesions (like endometrial polyps and submucous broids) and diffuse lesions (like adenomyosis, endometrial hyperplasia and cancer). Endometrial carcinoma is rare before the age of 40 years and its incidence rises steeply between ages 45 and 55.12,13 Between 5 and 10% of all women with postmenopausal bleeding will have endometrial cancer.14 Endometrial hyperplasia and cancer Endometrial hyperplasia is deemed a precursor of endometrial cancer. The depth of mucosa is evaluated by simple pressure of the tip of the endoscope. In comparison with the normal smooth, thin, endometrium without vascularization, features of increased endometrial thickness, abnormal vascularization and polypoid formations are considered the hysteroscopic features of hyperplasia (severe glandular with or without atypia). Mamillations and cerebroid irregularities associated with irregular polylobular, friable excrescences with necrosis or bleeding are considered diagnostic hysteroscopic features of malignancy.15 Differential diagnosis in postmenopausal bleeding Postmenopausal women should be seen within 2 weeks of referral:  Endometrial pathology:  endometrial cancer  hyperplasia: simple, complex, or atypical  polyps  broids

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 Atrophic endometrium: frequent diagnosis  Hormonal effect: proliferative or secretory endometrium, particularly in users of hormone replacement therapy  Cervical, vaginal or vulval pathology  Extragenital tract source, per rectal bleeding or haematuria. Blind dilatation and curettage samples only 60% of the endometrium16; most focal lesions (polyps and broids) that will be obvious at hysteroscopy are missed by dilatation and curettage.17 The sensitivity and specicity of Pipelle endometrial sampling for endometrial cancer are 99.6% and 91%, respectively.18 For women with postmenopausal bleeding, the best balance of sensitivity versus specicity is obtained at endometrial thickness measurement of 5 mm, 92% and 81%, respectively.16,19 Infertility The main indication for hysteroscopy in the investigation of infertility is in clarifying intrauterine pathology when an abnormal hysterosalpingography result is obtained, e.g. endometrial polyps, submucous broids, intrauterine adhesions (Synechiae) or uterine septa. Endometrial polyps Around 10% of women presenting with infertility have endometrial polyps.20 There has been some suggestion that women with polyps have a higher rate of miscarriage but there is no evidence of lower pregnancy rates in this group. The value of routine hysteroscopic removal of these polyps is unknown. Fibroids Fibroids have rarely been shown to be a direct cause of infertility but might affect fertility indirectly. Some studies indicate high success rates in both pregnancy and live births following removal of broids in women with otherwise unexplained infertility.21,22 Type 0 and type 1 submucous broids that distort the uterine cavity are well placed for hysteroscopic diagnosis and removal. Most authors recommend removal of broids no more than 2 cm in diameter in the outpatient setting. Intrauterine synechiae (Ashermanns syndrome) This is usually the result of intraoperative or postoperative complications during uterine evacuation, termination of pregnancy or hysteroscopic surgery. It can also be caused by uterine infections. Ashermanns syndrome has been found in 13% of women undergoing routine infertility investigations.23 Typical symptoms are menstrual irregularities, amenorrhea and miscarriage. Outpatient hysteroscopy is ideal for the detection of intrauterine adhesions. Recurrent miscarriage Congenital anomalies of the uterus Congenital anomalies associated with infertility include uterine didelphis, unicornuate/ bicornuate uterus and septate uterus. There is a high rate of spontaneous miscarriage

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and of preterm labour (between 25% and 47%) when these structural anomalies exist.24,25 Hysteroscopy is not useful in diagnosing cervical incompetence, but it can identify cervical adhesions, atresia and polyps. Cervical incompetence should be suspected when, on withdrawal of the hysteroscope, the sphincter-like action of the internal os disappears. The surgeon should also suspect cervical incompetence when the uterus fails to distend with the loss of the uid coming back through the cervix. INDICATIONS FOR AMBULATORY OPERATIVE HYSTEROSCOPY Improvements in the design and the manufacturing of smaller-diameter hysteroscopes have made it possible to carry out operative hysteroscopy in the outpatient setting without the need for cervical dilatation or anaesthesia in most cases. Other advances include the use of bipolar energy rather than monopolar energy, thus making it possible to use normal saline rather than non-ionic distention media (glycine, sorbitol or mannitol).These advances have made ambulatory operative hysteroscopy a safe, cost-effective procedure. Targeted biopsy Suspicious or abnormal-looking focal lesions in the endometrium are best biopsied using a grasping forceps passed down the operating channel. Endocervical and endometrial polypectomy Polyps on the ectocervix can be removed by avulsion if they are pedunculated or using a LLETZ loop if they are sessile. This is best done after the hysteroscopy is completed to prevent any bleeding obscuring vision. Polyps in the endocervical canal are removed using the technique described below for endometrial polyps. Endometrial polyps are formed by proliferation and hypertrophy of the basal layer of the endometrium, with varying risk of malignancy.26 At hysteroscopy they are smooth and soft, indenting easily on contact, and often have very little vascularization. They are either sessile or pedunculated. They can be removed by using scissors or graspers, the bipolar electrodes (the twizzle or the spring electrode). The disadvantage of this method is that there is no histology. Most experts would recommend that polyps of <3 cm in diameter can be removed this way. This can be achieved in less than 15 minutes and will be tolerated by most women. Treatment of submucous broids When seen at hysteroscopy, submucous broids show a supercial vascularization through a thin endometrium, as well as the whitish aspect of the myoma tissue. They feel rm and cannot be indented easily with the hysteroscope. Most experts would recommend that only type 0 and type 1 submucous broids, of <2 cm in diameter, are treated in the outpatient setting. They can be treated using mechanical instruments, i.e. scissors or ablated using the bipolar spring electrode.

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Division of intrauterine adhesions Adhesions are classied as mild, moderate or severe. Mild adhesions are lmy, thin and usually of recent occurrence. Moderate adhesions are bromuscular, thick and might bleed on division. Severe adhesions are usually composed of connective tissue only, without endometrial covering, and are unlikely to bleed. Division of the moderate and severe forms often requires general anaesthesia and concomitant laparoscopy. In the outpatient, setting a scissors or twizzle electrode is used for division under hysteroscopic vision. Around 90% of patients have normal menstruation following treatment and 60e70% pregnancy rates follow, depending on the severity before treatment.27 Division of uterine septa Approximately 25% of women with a septate uterus have recurrent pregnancy loss.24 The septa are poorly vascularized, making them ideal for hysteroscopic division. Hysteroscopic division with scissors sufces for the thin septum, whereas thicker and broader septa might require a cutting electrode (e.g. twizzle) or the use of a resectoscope under general or regional anaesthesia. Every effort should be made to ensure a thick covering of myometrium at the uterine fundus (transvaginal scan). If this is not certain then the division is best carried out under laparoscopic control. Hysteroscopic division offers high success rates; successful pregnancy rates of 85e90% have been quoted in some series.28,29 Generally, patients are advised to delay pregnancy for at least 4e6weeks. Removal of a lost intrauterine contraceptive device A pelvic ultrasound scan will locate the IUD and conrm its presence inside the cavity. If there is doubt, a plain abdominal X-ray should be ordered. Outpatient hysteroscopy is invaluable in the removal of the IUD from the uterus. A hysteroscope with an operative channel is used with a grasping forceps inserted into the uterus and either the thread or the IUD itself is grasped with the forceps and the hysteroscope is withdrawn together with the IUD. Outpatient hysteroscopic sterilization: Essure Hysteroscopic sterilization performed in an outpatient setting aims to reduce the risks from a general anaesthesia, has a shorter recovery period and aims to be cost effective. A new method that aims to achieve this is the Essure permanent contraceptive system, developed by Conceptus, Inc. The Essure system consists of the Essure microinsert, a disposable delivery system and a disposable split introducer. A standard hysteroscope with a 5 French working channel, continuous ow and a 12- to 30degree angled lens are used when sterilizing with inserting Essure. The Essure microinsert consists of a stainless steel inner coil, a nitinol, super-elastic outer coil and polyethylene (PET) bres. The microinsert is 4 cm in length and 0.8 mm in diameter. When released, the outer coil expands to 1.5 to 2.0 mm to anchor the microinsert in the varied diameters and shapes of any fallopian tube. The microinsert remains anchored in the fallopian tube, placed across the uterotubal junction. The diameter of the microinsert is larger trailing into the uterus than within the tubal lumen.

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This difference in the diameters is intended to prevent migration toward the peritoneal cavity. The PET bre mesh and the microinsert act as scaffolding into which brous tissue grows, anchoring the microinsert within the fallopian tube and occluding the tube, resulting in sterilization. In early studies30,31, bilateral tubal occlusion was demonstrated in 96% of cases and 6-month follow-up conrmed bilateral occlusion in all patients. Essure is 99.80% effective in preventing pregnancy after 3 years of follow-up. It can be performed in 15e25 minutes and has a high patient satisfaction rating. Bilateral placement rate occurs in 86% (rst attempt) and 90% (with second attempt).32 An alternative method of contraception must be used for 3 months after the procedure. Outpatient endometrial ablation Endometrial ablation is designed to treat abnormal uterine bleeding in women with no intrauterine pathology. Those ablative devices more suited for the outpatient setting are the second-generation, so-called global endometrial ablation devices. The energy sources used include hot water, microwave, radio frequency, laser and cryoablation. These procedures can be done in an outpatient setting using local anaesthetic. The balloon devices (Thermachoice and Cavaterm), microwave endometrial ablation, Hydro Therm Ablator and Novasure have all been approved by the National Institute for Clinical Excellence (NICE) and in the future NICE will undoubtedly approve the other devices. Balloon devices There are two balloons in clinical use. These use a combination of heating and pressure to achieve endometrial destruction. Cavity size is also limited to between 4 and 10 cm. They cause pain by uterine distension during treatment under local anaesthetic. Most authors suggest a non-steroidal anti-inammatory drug before treatment and rescue analgesia if needed (nitrous oxide or paracervical block). Neither requires endometrial priming. The Thermachoice UBT System has an external diameter of 4.5 mm, so rarely needs cervical dilatation prior to insertion. The device is inserted into the uterus and expanded to pressures of between 160 and 180 mmHg using sterile dextrose 5%. A microprocessor controls heating to 87  C. Once the treatment temperature is reached, the treatment time is 8 minutes; the whole procedure usually takes 15 minutes. One-year patient satisfaction rates are 85%, with 15e3% amenorrhoea rates.33 Cavaterm is a similar device to Thermachoice UBT System but the silicone balloon is inated to 180e200 mmHg with a treatment temperature of 75  C for 15 minutes. The device has an external diameter of 8 mm so requires cervical dilatation before insertion. Cavaterm is not used frequently in the outpatient setting. Microwave endometrial ablation The microwave endometrial ablation device uses a software-controlled unit with microwave energy at a xed frequency of 9.2 GHz; the operating power is 42 W. The microwave energy is delivered by an 8-mm-diameter probe, which heats the tissue to 80e90  C. This gives reliable tissue destruction to a depth of 4e5 mm. It is performed under local anaesthetic but the cervix needs dilating to Hegar 9 before

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insertion so 4-quadrant cervical block is recommended. However, there is no uterine distension and the treatment time is short: 3 minutes in a normal-sized cavity. The success rate at 1 year is 87% and amenorrhoea rates of 33e53% have been reported.33,34 The microwave endometrial ablation device is the only device initially licensed for use in patients with submucous broids up to 3 cm in diameter or a uterine cavity depth of up to 14 cm. Women who have had lower segment caesarean section can be treated providing the scar thickness measured by transvaginal sonography (TVS) is >8 mm. Endometrial priming is recommended. Hydro ThermAblator The Hydro ThermAblator system occludes the cervix and destroys the endometrium by circulating low pressure (50e55 mmHg) heated saline under vision in the uterine cavity. The insulated, disposable sheath is 7.8 mm in diameter and ts over most commercially available 3-mm hysteroscopes. The cervix needs dilatation to Hegar 8 to allow insertion of the device. The uterine cavity should measure <12 cm but cavities with broids can be treated. It takes 3 minutes to heat the saline to treatment temperature of 90  C. The treatment time is then 10 minutes followed by a cooling period of a further 1 minute before the device can be withdrawn. The heated saline thus bathes the endometrial cavity with the cervix sealed. Because of the low pressures used (lower than the 60 mmHg opening pressure of the tubal ostia) uid spillage into the peritoneal cavity does not occur. It has been performed under local anaesthesia using paracervical block but the procedure time of 15 minutes makes treatment in the outpatient setting less appealing to the patient. One-year success rate is 94% with reported amenorrhoea rates of 40e60%.33,35 Endometrial priming is recommended. NovaSure NovaSure is a disposable impedance-controlled device. No endometrial priming is needed. It uses bipolar energy delivered through a gold-plated mesh mounted on a exible frame, which conforms to the shape of the uterine cavity. The device is 6.9 mm in diameter and so requires cervical dilatation. Regular cavities between 6 and 11 cm can be treated with this device. Cavity integrity is checked using a small amount of CO2. The device vaporizes the endometrium, regardless of thickness, using bipolar energy. As tissue destruction continues, the resistance to ow of current increases until tissue impedance reaches 50 ohms. Treatment time is calculated by the generator based on tissue impedance. When impedance reaches 50 ohms or treatment time reaches 2 minutes, treatment is complete. Procedure time has been reported at 5 minutes. There is no uterine distension. The amenorrhoea rate at one year is 43% and success rate of 90%.36 Contraindications to ambulatory hysteroscopy Absolute contraindications  Cervical cancer: hysteroscopy should not be performed in the presence of cervical carcinoma (in situ or invasive) because of the danger of opening blood or lymphatic vessels and causing systemic dissemination of malignant cells.  Heavy uterine bleeding: hysteroscopy should be avoided during menstruation, because of a theoretical risk of dissemination of endometriosis and mainly because

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the view is usually unsatisfactory. Moderate uterine bleeding does not prevent adequate visualization of the endometrial cavity.  Pelvic inammatory disease: because of the danger of causing extended ascending infection and peritonitis. Relative contraindications  Pregnancy: generally considered a contraindication to hysteroscopy but it might be necessary to perform hysteroscopy to remove an IUD or to diagnose retained products of conception when there has been persistent postabortal bleeding, although ultrasound has replaced endoscopy in many such cases. The myometrium in the gravid uterus is much more distensible than in the non-pregnant organ. Uterine distension with gas can cause the uterus to distend like a balloon, which can result in retroplacental bleeding or a massive gas embolus. It is important, therefore, that hysteroscopy in pregnancy is performed only by an expert surgeon and that the gas ow is restricted to 20 mI/minute. It is also important to remember that the optic nerve of the fetus can be damaged by the hysteroscope light after the tenth week of pregnancy.  Recent uterine perforation: the risk of repeat uterine perforation is considerably greater in such patients as the healing process might have left a weak scar.  Cervical stenosis: the risk of uterine perforation is considerably greater in such patients. The role of experienced operator can not be more reinforced.  Cardiorespiratory disease.  Uncooperative patient: although this can be overcome using the vaginoscopic technique. COMPLICATIONS OF DIAGNOSTIC/OPERATIVE AMBULATORY HYSTEROSCOPY Ambulatory hysteroscopy is a safe procedure. Most complications of hysteroscopy are rare and, if they do occur, are seldom life-threatening, particularly in diagnostic procedures. A recent Royal College of Obstetricians and Gynaecologists guideline for gaining consent for diagnostic hysteroscopy under general anaesthetic quoted a gure as low as 8/1000 for uterine perforation37; the gure is much lower for ambulatory procedures. A large systematic review7 of studies of over 25,000 women reported only eight (3/10,000) cases of potentially serious complications (a pelvic infection, uterine perforations4, a bladder perforation, and precipitation of a hypocalcaemic crisis/anginal episode). Operative hysteroscopic procedures are more risky, with uterine perforation being the most common complication. Among other hysteroscopic procedures, resection of broids and uterine septa have signicantly higher rates of complications (4e7 times more operative complications than polypectomy)38, mainly due to uid intravasation. Ambulatory operative procedures tend to be short in duration and, as the patient is awake and responsive to painful stimuli, the chances are that uid intravasation problems are unlikely and difcult procedures will be abandoned early due to patient intolerability minimizing risk of complications. Complications of hysteroscopy in the ambulatory setting In a large observational clinical study in Italy39, 501 women were treated for benign intrauterine pathologies using an outpatient hysteroscopic procedure, without

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analgesia or anaesthesia. A Versapoint 5 French bipolar electrode was used to treat endometrial polyps ranging between 0.5 and 4.5 cm, as well as submucosal and partially intramural myomas between 0.6 and 2.0 cm. No failures or major complications (i.e. severe pain, vagal reex, intravasation, uterine perforation, bleeding) occurred during the procedures. Generally, most complications are related to the surgeons experience and the type of procedure. Intraoperative complications Vasovagal reex This commonly occurs when dilating the cervix or passing the hysteroscope. The prevalence of vagal reaction (1 in 300 cases) depends on the ability of the endoscopist and on the diameter of the scope. Cervical trauma Operative ambulatory procedures can often be performed without the need to dilate the cervix, especially with the Versascope and particularly if the vaginoscopic technique described by Bettocchi et al is used.40 However, operative hysteroscopy might require cervical dilatation. Trauma can be dealt with using pressure, silver nitrate or sutures. It is best to avoid overdilating the cervix because this can result in leakage of the distending media through the cervix and around the hysteroscope. Always introduce the hysteroscope under direct vision. Uterine perforation Uterine perforation is a rare event. In a large systematic review7 of studies of over 25,000 women, only four (1/6000) cases of uterine perforation occurred. Even for inpatient operative procedures, the incidence is low. The uterus might be perforated by a dilator, the hysteroscope or an energy source. Management will depend on the size, site of the perforation and whether there is risk of injury to another organ. Perforation occurs more frequently at the level of the fundus without signicant bleeding. Simple perforation rarely causes any further damage and can be treated conservatively by admission, observation and appropriate broad-spectrum antibiotics. Laparoscopy might be considered to exclude bleeding. Complex perforation might be made with mechanical or an energy source and therefore can be associated with thermal injury to adjacent structures including bowel or large vessels. However, energy sources used in the outpatient setting are usually bipolar energy (Versapoint), or heat (Thermachoice), which offer reduction of energy spread through the tissue during the procedure and hence high levels of safety. Haemorrhage Intra- or postoperative bleeding can be caused by:  the tenaculum (only used if dilating cervix)  uterine perforation  the procedure.

966 S. H. Bakour et al

Management will depend on the site, severity and cause of the bleeding. Intrauterine bleeding occurring during the procedure should be immediately obvious and can usually be controlled by spot electrocoagulation. If coagulation fails to control the bleeding, the procedure might have to be abandoned and tamponade performed by inserting a Foley catheter and distending the balloon. The catheter should be left in situ for 4e6 hours, after which the bleeding nearly always stops. Delayed complications of ambulatory hysteroscopy Infection An incidence of 2/1000 of infection has been reported in over 4000 diagnostic hysteroscopies. Acute pelvic inammatory disease following hysteroscopic surgery is rare. The diagnosis is made from the classic symptoms and signs, and treatment should be by appropriate antibiotics following culture of vaginal swabs and blood. Vaginal discharge Vaginal discharge is common after any ablative procedure and can sometimes be prolonged (2e3 weeks), although it is usually self-limiting. Patients should alert their healthcare provider if the vaginal discharge becomes offensive or if she develops pyrexia, heavy bleeding or severe lower abdominal pain. Adhesion formation Intrauterine adhesions are common, especially after myomectomy when two broids are situated on opposing uterine walls. In this case, the myomectomy is better performed in stages to prevent adhesion formation. An intrauterine device and 2 months administration of oestrogen and progestogen therapy (in the form of combined oral contraceptives) can help prevent adhesion formation following resection, adhesiolysis or division of a septum. Box 1 summarizes how complications can be avoided.

Box 1. How can we avoid complications? Preoperative factors to consider  Complexity of procedure  Size of uterus  The role of misoprostol when expecting a difcult dilatation  Overall health status and co-morbidity  Operators experience Preoperative optional imaging studies These have a role as a diagnostic aid providing additional information about the cavity that can be useful during surgery:  Hysterosalpingogram  Sonohysterogram

Ambulatory hysteroscopy 967

 Transvaginal ultrasound  Computerized tomography or magnetic resonance imaging Intraoperatively  Keeping operating times to a minimum  Keeping uid pressure as low as possible because of uid absorption if it exceeds venous pressure  Meticulous uid balance: the procedure must be abandoned if the decit rises to 750e1000 mL

ACCURACY OF DIAGNOSTIC AMBULATORY HYSTEROSCOPY When the uterine cavity is adequately visualized, hysteroscopy is highly accurate and thereby clinically useful in the diagnosis of endometrial cancer. The diagnostic accuracy of hysteroscopy for endometrial cancer is such that the likelihood ratios (LRs) are 62 and 0.15 for positive and negative results, respectively. The pre-test probability increases with a positive result (Figure 1) and decreases with a negative result (Figure 2).41,42 The diagnostic accuracy of hysteroscopy in endometrial cancer and hyperplasia is more modest, so that it cannot be ruled in or excluded with a high level of certainty. For endometrial cancer and hyperplasia, the pooled LRs are 10 and 0.24 for positive and negative hysteroscopy results, respectively. The probability changes are not as profound with these LR values. This relatively inferior performance of hysteroscopy in detecting endometrial disease in comparison to its performance in detecting endometrial cancer is probably because features of hyperplasia are not clearly distinct. For diagnosis of benign submucous broids and endometrial polyps, hysteroscopy has quite a high degree of accuracy (Figure 3).26,41,42 Performance of hysteroscopy as a test does not appear to be altered by menopausal status. Compared to the inpatient setting, outpatient hysteroscopy has a marginally higher failure rate but appears to have a trend towards improved diagnostic performance. There is a tendency towards improved diagnostic accuracy for outpatient hysteroscopy for both endometrial cancer and disease compared with inpatient procedures.7

Comparison with ultrasound and endometrial biopsy A comparison of accuracy of these tests is provided in Figure 3. Although endometrial biopsy is accurate and a relatively inexpensive test for identifying endometrial malignancy and premalignancy, it is a poor test for diagnosing benign endometrial abnormalities such as atrophy, polyps and submucosal broids, which are far more common causes of bleeding. Transvaginal ultrasonography techniques have better accuracy in the identication of benign conditions than endometrial biopsy. In comparison, hysteroscopy can detect small polyp or submucous broids that have been missed by endometrial biopsy. Hysteroscopy is considered the gold standard for the accurate detection of these intrauterine pathologies for its superiority in directly visualizing these lesions.7,41

968 S. H. Bakour et al

Generating post-test probabilities for a positive test

.1 .2 .5 1 2 5 1000 500 200 100 50 20 10 5 2 1 .5 .2 .1 .05 .02 .01 .005 .002 .001 95 90 80 70 60 50 40 30 20 10 5 2 1 .5 .2 .1 99

Posttest probability with negative test 90

Pretest probability of endometrial cancer without testing 13

10 20 30 40 50 60 70 80 90 95

Likelihood ratio = 62

Likelihood Ratio
99

Pretest probability

Posttest probability

Nomogram adapted from N Engl J Med 1975;293:257.

Post-test probabilities of endometrial cancer according to risk groups based on age

Age group Pre-test probability* Post-test probability+ < 50 years 0.5 24 51--60 years 1.0 39 > 60 years 13.0 90 * Obtained from population based data + Computed using the following formula: Posttest probability = Likelihood ratio Pre-test probability [1 Pre-test probability (1 Likelihood ratio)]
Figure 1. Change from pre-test to post-test probabilities using likelihood ratios. The impact of abnormal hysteroscopy ndings (positive hysteroscopy) on the likelihood of endometrial cancer among postmenopausal women with vaginal bleeding. (With permission of Royal Society of Medicine Press.)

Using a 5-mm threshold to dene abnormal endometrial thickening generally, it can be concluded that transvaginal ultrasound can accurately identify postmenopausal women with vaginal bleeding who are highly unlikely to have signicant endometrial disease so that endometrial sampling or even hysteroscopy might be unnecessary.14,16,19 The role of sonohysterography or saline infusion sonography is developing. It involves instillation of 5e15 mL of normal saline into the uterine cavity for better detection of endometrial polyps and submucous broids. Role of outpatient endometrial biopsy Outpatient endometrial biopsy has modest accuracy in diagnosing endometrial hyperplasia.6,18 The sensitivity and specicity of Pipelle endometrial sampling for endometrial cancer is high, at 99.6% and 91%, respectively.18 The sample adequacy rate ranges from 90 to 95% in the premenopausal group.43,44 For postmenopausal patients,

Ambulatory hysteroscopy 969

Generating post-test probabilities for a negative test

.1 .2 .5 1 1000 500 200 100 50 20 10 5 2 1 .5 .2 .1 .05 .02 .01 .005 .002 .001 95 90 80 70 60 50 40 30 20 10 5 2 1 .5 .2 .1 99

Pretest probability of endometrial cancer without testing 13

2 5 10 20 30 40 50 60 70 80 90 95

Likelihood ratio = 0.15

Posttest probability with negative test 2

Likelihood Ratio
99

Pretest probability

Posttest probability

Nomogram adapted from N Engl J Med 1975;293:257.

Post-test probabilities of endometrial cancer according to risk groups based on age

Age group Pre-test probability* Post-test probability+ < 50 years 0.5 0 51--60 years 1.0 0 > 60 years 13.0 2 * Obtained from population based data + Computed using the following formula: Post-test probability = Likelihood ratio Pre-test probability [1 Pre-test probability (1 Likelihood ratio)]
Figure 2. The impact of normal hysteroscopy ndings (negative hysteroscopy) on the likelihood of endometrial cancer among postmenopausal women with vaginal bleeding. (With permission of Royal Society of Medicine Press.)

the adequacy rate is signicantly lower probably because of the atrophic endometrium. Outpatient endometrial sampling has a procedure failure rate and a tissue-yield failure rate of approximately 10%.16 It should be noted that yield failures are not unexpected in women with atrophic endometrium, whereas failure to obtain tissue would be less likely if cancer was present. The false-negative rate for endometrial carcinoma is low and endometrial biopsy is therefore accurate in excluding endometrial carcinoma. In general, additional assessment of the endometrial cavity should be undertaken, especially if symptoms persist or intrauterine structural abnormalities are suspected.

Role of transvaginal sonography Patients referred to the one-stop outpatient hysteroscopy clinic with abnormal uterine bleeding might also have a transvaginal ultrasound scan. In postmenopausal women, thickening of the endometrium (>4 mm) might indicate the presence of pathology.19

970 S. H. Bakour et al
Tests Likelihood ratio Negative test Positive test

Tests for endometrial cancer

Hysteroscopy Transvaginal ultrasound at 5mm cutoff Miniature endometrial biopsy

Tests for endometrial cancer plus hyperplasia

Hysteroscopy Transvaginal ultrasound at 5mm cutoff Miniature endometrial biopsy (hyperplasia only)

Tests for submucous fibroid

Hysteroscopy Transvaginal ultrasound Saline infusion sonography

Tests for endometrial polyp

Hysteroscopy Transvaginal ultrasound Saline infusion sonography 0.1 1 10 Likelihood ratio (LR) Negative Test Useless Test Positive Test Useful Test

Figure 3. Comparison of accuracy of hysteroscopy with other modalities for diagnosis of malignant, premalignant and benign condition among women with abnormal uterine bleeding. (With permission of Royal Society of Medicine Press.)

In general, the thicker the endometrium, the greater the likelihood of important pathology (endometrial cancer) being present. Transvaginal ultrasonography can reliably assess thickness and morphology of the endometrium and can thus identify a group of women who have a thin endometrium and are therefore unlikely to have signicant endometrial disease. This group might not require any further investigation unless there is a recurrence of bleeding.16 Those patients with thickened endometrium require further investigations in the form of hysteroscopy and endometrial sampling. In premenopausal women with abnormal uterine bleeding, the endometrium undergoes cyclic changes in response to ovarian steroid hormone stimulation. Hence, the thickness of the endometrium varies and it becomes difcult to establish guidelines as to what should be considered normal thickness. Saline-enhanced transvaginal ultrasonography for endometrial texture and margin analysis can be used to help improve diagnostic accuracy. Other ultrasonographic techniques, such as transvaginal Doppler ultrasonography and three-dimensional ultrasonography, are being introduced gradually for improving discrimination between anomalies (e.g. polyps versus broids). There is not enough evidence to support their introduction into routine clinical practice at present. Test combinations There remains an ongoing debate about the choice between ultrasound, endometrial biopsy and hysteroscopy in the management of women presenting with abnormal uterine bleeding. Some have recommended test combinations, e.g. pelvic ultrasound scan

Ambulatory hysteroscopy 971

and/or outpatient hysteroscopy.45 Ultrasonography is considered less invasive than hysteroscopy and it is accurate at ruling-out endometrial cancer and hyperplasia in postmenopausal women. Ambulatory hysteroscopy is accurate at ruling-in endometrial cancer and hyperplasia. Thus a transvaginal ultrasound scan might be employed as an initial test followed by hysteroscopy in women with abnormal uterine bleeding who have a positive result on ultrasound scanning. Endometrial sampling could also be considered as an initial test for excluding malignancy.

RISK MANAGEMENT FOR AMBULATORY HYSTEROSCOPY Patient safety Patient safety is at the very core of risk management; it is the rst and foremost domain of healthcare. Whereas historical data from incident reporting is very useful, a more proactive approach is essential if hidden or unidentied risks are to be identied. For an ambulatory hysteroscopy service, a regular risk assessment will enable the identication of risks. A framework for performing risk assessment might involve mapping a patients journey through the hysteroscopy service, assessing the following areas for clinical and non-clinical risks:      environment: equipment, medicines use, infection control stafng: number, training patient assessment: availability of medical records, documentation patient treatment: guidelines and consent discharge/follow-up arrangements.

When the procedure is broken down in this way, it is clear that errors or mistakes can happen at any stage. Specic areas for risk management in ambulatory hysteroscopy include: documentation, consent and adequate training before performing new procedures. For an ambulatory hysteroscopy service to achieve the above objectives it cannot operate in isolation from other areas of health provision, e.g. clinic administration, gynaecological pathology, and primary care. Interfaces between these areas represent potential barriers to patient safety.

TRAINING IN AMBULATORY HYSTEROSCOPY Formal hysteroscopy training programmes and accreditation are rapidly expanding among gynaecologists. In general, a distinction has to be made between two types of training programme:  Diagnostic hysteroscopy training programme: can be undertaken by any interested professional: a nurse, a GP or a gynaecologist. The training focuses mainly on hysteroscopy as a diagnostic procedure for women with abnormal uterine bleeding.  Advanced hysteroscopic surgery training programme: should be particularly directed at gynaecologists, either in training or qualied specialists, interested in providing treatment.

972 S. H. Bakour et al

Whatever the training programme, trainees should progress through a structured educational system with appropriate supervision, formal instruction and critical assessment and evaluation under the supervision of preceptors. SUMMARY The aim of investigations of abnormal uterine bleeding is to diagnose endometrial cancer, hyperplasia and benign pathology. Ambulatory hysteroscopy in a one-stop clinic is efcient, has an accuracy higher than inpatient hysteroscopy and results in increased patient satisfaction as a result of the rapid alleviation of anxiety, faster recovery and less time away from work and home. The key merit of this one-stop approach is to increase the activity through an outpatient setting by giving women the option of treatment at the time of diagnosis, i.e. see and treat. Vaginoscopy can be used to eliminate patient discomfort related to the traditional approach. Improvements in the last decade in the design and the manufacture of smallerdiameter hysteroscopes (<5 mm) have made it possible to perform operative hysteroscopy in the outpatient setting without the need for cervical dilatation or anaethesia in most cases. Other advances include the use of bipolar as opposed to monopolar energy, thus making it possible to use normal saline rather than non-ionic distention media. Most experts would recommend that only type 0 and type 1 submucous broids of <2 cm in diameter, and polyps <3 cm, should be treated in the outpatient setting. Most of the complications of ambulatory hysteroscopy are rare and are seldom life-threatening. The possibility of uterine perforation is very small but should be borne in mind. Hysteroscopy is highly accurate and therefore clinically useful in the diagnosis of endometrial cancer. However, the diagnostic accuracy of hysteroscopy in endometrial hyperplasia is more modest. For polyps and submucous broids, hysteroscopy is considered the gold standard. Performance of hysteroscopy as a test does not appear to be altered by menopausal status. The relative roles of ultrasound, endometrial biopsy and hysteroscopy and their combinations for diagnosis of pathology remain a topic of debate. Practice points  Knowledge of the room set-up and available instruments is crucial for successful outpatient hysteroscopy.  The hysteroscope should always be the rst instrument to be inserted into the cervical canal; dilatation of cervix is not necessary in a majority of cases.  A panoramic view of the endometrial cavity allows an assessment for abnormalities. Assessment of the cervical canal on removal of the hysteroscope captures cervical pathology.  Endometrial carcinoma is rare before the age of 40 years and its incidence rises steeply between 45 and 55 years. Between 5 and 10% of all women with postmenopausal bleeding will have endometrial cancer.  Blind dilatation and curettage samples only 60% of the endometrium; most focal lesions (polyps and broids) that are obvious at hysteroscopy are missed by dilatation and curettage.  Essure is a new system that tries to achieve permanent contraception via outpatient hysteroscopic sterilization.

Ambulatory hysteroscopy 973

 The second-generation ablative devices most suited for the outpatient setting using local anaesthetic are: Thermachoice and Cavaterm, microwave endometrial ablation, Hydro ThermAblator and Novasure.  Outpatient hysteroscopy has a marginally higher failure rate than hysteroscopy in the inpatient setting.  There is a tendency towards improved diagnostic accuracy with outpatient hysteroscopy over inpatient procedures.  The diagnostic hysteroscopy training programme can be undertaken by any interested professional: a nurse, a general practitioner or a gynaecologist.  Advanced hysteroscopic surgery training is aimed at gynaecologists e either residents in training or qualied specialists. It should be delivered under the supervision of a preceptor to inculcate operative skills in an ambulatory setting.

Research agenda  Future development of subspecialization: it has been suggested that the way forward is to develop advanced hysteroscopic surgery as a recognized subspecialization.  To date, there is no ofcial accreditation of such a subspecialization in hysteroscopy but many individual clinicians have achieved the levels of excellence outlined below through personal interest and training:  To improve knowledge, practice, teaching and research in the subspecialty.  To promote the concentration of very specialized expertise, special facilities and clinical material that will be of considerable benet to some patients.  To establish a close understanding and working relationship with other disciplines involved in this subspecialty.  To encourage coordinated management of relevant clinical services throughout a region.  To accept a major regional responsibility for higher training, research and audit in the subspecialty.  To improve the recruitment of highly talented trainees into the recognized subspecialty.

ACKNOWLEDGMENTS No work can ever be completed without the support of many individuals. The authors would like to thank families and friends who supported the project of writing this book. We are particularly grateful to the following colleagues for their contributions outlined below:  Professor Khalid Khan, Professor of Obstetrics-Gynaecology and Clinical Epidemiology Honorary Consultant Obstetrician-Gynaecologist Birmingham Womens Hospital, Birmingham, UK

974 S. H. Bakour et al

 Mr Linga Dwrakanath MRCOG, Consultant/Honorary Senior Lecturer in Obstetrician and Gynaecologist, City Hospital, Birmingham, UK  Mr Alaa El-Gobashy M.B.Ch.B, MSc, MD, MRCOG, Specialist Registrar, Bradford Royal Inrmary, UK  Mr Joseph Ogah MB BS, MRCOG, Specialist Registrar, Bradford Royal Inrmary, UK  Dr Janet Wright BSc MB BS, MRCOG, Consultant Obstetrician and Gynaecologist and Risk Management Lead, Bradford Royal Inrmary, UK We would like also to thank the following companies for providing the book with relevant images:     Boston Scientic GynaCare Karl Storz Microsulis

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