Ambulatory hysteroscopy

Transcription

1 DOI: /tog The Obstetrician & Gynaecologist ;15: Review Ambulatory hysteroscopy Natalie AM Cooper MBChB, a T Justin Clark MD, MRCOG b, * a Obstetrics and Gynaecology Specialty Trainee, Birmingham Women s Hospital, Mindelsohn Way, Edgbaston, Birmingham B15 2TG, UK b Consultant Obstetrician and Gynaecologist and Honorary Reader, Birmingham Women s Hospital, Mindelsohn Way, Edgbaston, Birmingham B15 2TG, UK *Correspondence: T. Justin Clark. justin.clark@bwhct.nhs.uk Accepted on 15 February 2013 Key content Routine diagnostic hysteroscopy under general anaesthesia is an anachronism. Evidence-based RCOG guidance should be followed to ensure best practice in outpatient hysteroscopy. The role of hysteroscopy in the diagnostic work-up of abnormal bleeding and reproduction remains unclear and further research is required to elucidate where it can be used most cost-effectively. Learning objectives A no touch vaginoscopic technique should be employed routinely as this approach reduces pain during diagnostic rigid outpatient hysteroscopy and facilitates operative procedures by improving manipulation of miniature endoscopic equipment. A contemporary outpatient hysteroscopy service should be able to provide surgical treatments for uterine polyps, small fibroids, lost coils, minor uterine anomalies, menstrual disorders and permanent contraception. Ethical issues Can we justify subjecting women, especially those with significant medical co-morbidities, to the risks and inconvenience of general anaesthesia for hysteroscopic procedures? Keywords: hysteroscopy / one-stop / outpatients / see and treat Please cite this paper as: Cooper NAM, Clark TJ. Ambulatory hysteroscopy. The Obstetrician & Gynaecologist 2013;15: Introduction Direct visualisation of the vagina, cervix and uterine cavity with the aid of an endoscope does not just facilitate diagnosis of disease, but also provides therapeutic possibilities, either directly ( hysteroscopic surgery ) or indirectly (directing blind procedures including global endometrial ablation). Such interventions were traditionally the domain of hospital day-case wards with procedures performed under general anaesthesia. This is no longer the case. The advent of small diameter modern hysteroscopes ( 5.5 mm), allied with the miniature 5 7 Fr ancillary instruments (mechanical instruments: scissors; graspers; biopsy cups; bipolar electrodes, e.g. Versapoint TM [Gynecare, Ethicon Inc., Menlo Park, CA, USA]; morcellators: TRUCLEAR TM [Smith & Nephew Inc., Andover, MA, USA], MyoSure [Hologic, Marlborough, MA, USA]; and female sterilisation systems: Essure [Conceptus Inc., Mountain View, CA, USA]) has led the paradigm shift of surgical interventions being undertaken in an inpatient general anaesthetic setting to an outpatient environment with recourse to local anaesthesia if necessary. Thus, the modern gynaecologist is not restricted to efficient outpatient diagnosis using hysteroscopy, transvaginal ultrasound and endometrial biopsy, but can institute minimally invasive therapeutic interventions in an equally proficient manner. As a result, the philosophy of efficient, safe and convenient see and treat, one stop gynaecology in an ambulatory setting the patient ambulates in and ambulates out has come of age. We will discuss in this article the advances in outpatient hysteroscopy, taking account of the evidence to support interventions and recent best practice guidance. Conducting outpatient hysteroscopy A joint British Society for Gynaecological Endoscopy/ Royal College of Obstetricians and Gynaecologists (BSGE/RCOG) Green-top guideline addressing best practice in outpatient hysteroscopy has been recently published. 1 The aim of the guideline is to provide clinicians with up-to-date, evidencebased information regarding outpatient hysteroscopy, with particular reference to minimising pain and optimising women s experience. Thus, by standardising best practice and identifying areas where evidence is lacking, we can hope to optimise both current and future patient experience. Box 1 summarises the key recommendations for best practice in outpatient hysteroscopy and Box 2 summarises the key points of no touch vaginoscopic hysteroscopy which should be the default technique in an outpatient environment. 2 4 ª 2013 Royal College of Obstetricians and Gynaecologists 159

2 Ambulatory hysteroscopy Box 1. Summary of recommendations for best practice in outpatient hysteroscopy 1. All gynaecology units should provide a dedicated outpatient hysteroscopy service which is appropriately sized, equipped and staffed and located outside of the formal operating theatre setting. The healthcare professional(s) should have the necessary skills and expertise to carry out diagnostic and/or therapeutic outpatient hysteroscopy. 2. Written patient information should be provided before the appointment and consent for the procedure should be taken. 3. Women without contraindications should be advised to consider taking standard doses of NSAIDs 1 hour before their appointment, but routine use of opiate analgesia should be avoided. 4. Routine cervical preparation before outpatient hysteroscopy should not be used unless dilatation beyond Hegar 6 is anticipated. 5. Miniature hysteroscopic systems ( 4 mm outer diameter) should be used for diagnostic outpatient hysteroscopy. Choice of hysteroscope (e.g. flexible or rigid; 0 or fore-oblique distal lenses) should be left to the discretion of the operator. 6. Carbon dioxide or normal saline can be used as distension media for diagnostic outpatient hysteroscopy, but normal saline should be used for operative procedures. 7. Routine, blind cervical dilatation should be avoided. 8. Topical application of local anaesthetic to the ectocervix should be considered where a cervical tenaculum is necessary. Routine administration of intracervical or paracervical local anaesthetic should be used where larger diameter hysteroscopes are being employed (outer diameter >5 mm) and where the need for cervical dilatation is anticipated (e.g. cervical stenosis). Standard protocols regarding the type, maximum dosage and route of administration of anaesthesia should be implemented. 9. Conscious sedation should not be routinely used in outpatient hysteroscopic procedures. 10. Vaginoscopy (avoiding the use of a vaginal speculum or cervical instrumentation) should be the standard technique for outpatient hysteroscopy. Source: RCOG/BSGE Green-top guideline [ uk/files/rcog-corp/gtg59hysteroscopy.pdf] Box 2. Vaginoscopic no-touch technique The technique 1. Place the hysteroscope into the vagina and allow the distension media to flow in and distend the vagina. 2. Advance the scope towards the posterior fornix and look for the cervix. If not immediately visible, work slowly backwards from the vault, angling the hysteroscope upwards as you go (most uteri are anteverted) and sweeping side to side until you identify the cervix and find the external os. 3. Steer the hysteroscope into the cervical os, along the canal and into the uterine cavity under direct vision. 4. Directed biopsies can be taken using a biopsy cup via the operating channel of a rigid hysteroscope, or an H Pipelle can be used to take a global biopsy through the hysteroscopic sheath. 2,3 Tips to help identify the cervix vaginoscopically Mucus, blood or coil threads training from the cervical os can be followed to locate the cervix. A30 angled hysteroscope makes it easier to identify the cervix. If the cervix is difficult to locate consider eccentric placement, a deficient cervix flush with the vault, an acutely retroverted uterus with an anterior placed cervical os, or uterine prolapse with the cervix sited close to the introitus. If you still cannot identify the cervix, perform a digital examination to determine its position within the vagina. Advantages Vaginoscopy is significantly more comfortable for the patient than a hysteroscopy using a speculum, tenaculum and local anaesthesia and it does not increase the number of failed procedures. 4 It offers greater manoeuvrability for the operator as they are not restricted by the speculum. This is particularly useful when women have a raised body mass index, acutely flexed uteri or when close approximation of the hysteroscope to focal pathologies or access the tubal ostia for sterilisation is required. Vaginoscopy makes it possible to examine women who will not tolerate a vaginal or speculum examination or who have medical comorbidities that prevent adequate positioning and vaginal access, thereby precluding endometrial assessment with endometrial biopsy. Indications for diagnostic outpatient hysteroscopy The main indications for diagnostic hysteroscopy are shown in Box 3. The place of outpatient hysteroscopy (OPH) as a third-line test after transvaginal ultrasound (TVU) and endometrial biopsy in the diagnostic work-up of women with postmenopausal bleeding (PMB) is relatively well defined. 5 However, for the most part, whereas there are synergies between the available tests, there is also some crossover in the information provided. For example, the place of OPH relative to TVU, endometrial biopsy and saline infusion sonography in heavy menstrual bleeding (HMB) and non-menstrual bleeding is unclear. By contrast with a PMB population, women with HMB do not have a normal endometrial thickness and the risk of endometrial cancer or atypia is low. Thus, the utility of routine TVU, endometrial biopsy and OPH is questionable and this is borne out in the management algorithm produced by the National Institute for Health and Clinical Excellence (NICE). 6 However, women with HMB can have endometrial hyperplasia, submucous fibroids of various grades and sizes, uterine polyps, uterine anomalies including uterine fibroids and adenomyosis and benign adnexal masses. Non-diagnosis of these pathologies prevents implementation of the many effective medical and surgical treatments for HMB and is therefore likely to result in prolonged suffering, reduced health-related quality of life and absenteeism from work with costs to the economy. Current research involving decision analytical modelling hopes to provide us with some answers as to which testing strategies are the most cost-effective in HMB. 7 Before leaving diagnostic indications, it is worth considering the wider place of OPH in the management of 160 ª 2013 Royal College of Obstetricians and Gynaecologists

3 Cooper and Clark Box 3. Indications for diagnostic outpatient hysteroscopy a Abnormal uterine bleeding Postmenopausal bleeding with an endometrial thickness >4 mm or irregular endometrium on TVU or a non-diagnostic endometrial biopsy or on tamoxifen Recurrent postmenopausal bleeding Unscheduled/intermenstrual bleeding with an abnormal endometrium on TVU or refractory to medical treatment Heavy menstrual bleeding with fibroids or an abnormal endometrium on TVU or refractory to medical treatment Postpartum bleeding with suspected chronic retained products of conception or arteriovenous malformation on TVU Reproductive problems b Subfertility associated with an abnormal ultrasound or hysterosalpingogram Late miscarriage/preterm labour Other Glandular abnormalities on cervical smear Identification (and ) of lost intrauterine devices Incidental finding of an abnormal uterine cavity on TVU (mass, fluid etc.) a Hysteroscopy is only indicated under general or regional anaesthesia as day-cases where the outpatient setting has failed and the indication remains sufficiently strong (i.e. benefits of diagnostic information outweigh potential risks); patient preference; virginal women and some cardiac conditions where normal responses to vaso-vagal reactions are blunted b The role of hysteroscopy in investigating reproductive problems such as subfertility or recurrent pregnancy loss is contentious. There is some evidence from small RCTs that the use of hysteroscopy prior to in vitro fertilisation cycles in women with previously failed cycles of treatment may improve pregnancy rates by up to 60%. The European multicentre Trophy RCT 5 is currently evaluating whether outpatient hysteroscopy does indeed confer an advantage, although the reasons why it might remain unclear menstrual disorders, aiding safe intrauterine instrumentation (e.g. endometrial biopsy, levonorgestrel intrauterine system [LNG-IUS] insertion) and treatment planning. The latter role of OPH is often overlooked. For example, OPH may be useful in estimating the likely response of symptoms to minimally invasive treatments with LNG-IUS and endometrial ablation, based upon a hysteroscopic assessment of the endometrium, uterine size, capacity, shape and regularity. The test can also help determine the most appropriate treatment setting (i.e. outpatient versus day-case under general anaesthesia), based upon patients tolerance of the procedure and any adverse anatomical factors. Similarly, in the case of submucous fibroid(s), OPH in conjunction with TVU allows an assessment of treatment setting and need for endometrial preparation based upon the size, vascularity, number and location. It aids patient counselling as to the likelihood of needing repeated surgeries (2/3 stage resections) and the probability of symptomatic relief. Thus, the woman can make a more informed decision as to whether to opt for conservative hysteroscopic surgery or proceed to hysterectomy. Operative hysteroscopy Polyps The removal of uterine polyps appears to confer benefit in terms of resolving symptoms and obtaining tissue for histological examination Technological advances in imaging have resulted in better image quality, portability and accessibility, improving the detection rate of focal uterine pathologies. Improvements in hysteroscope design and ancillary instrumentation coupled with enhanced visualisation, due to improvements in fibre optics and digital imaging, have enabled polyps to be removed under direct hysteroscopic vision in an outpatient setting. Mechanical instruments designed to pass down 5 and 7 Fr operating channels have been used successfully, 12 but their utility is affected by their size and relative fragility. In the late 1990s the development of bipolar intrauterine electrosurgical systems (e.g. Versapoint TM bipolar electrosurgical system) facilitated rapid resection of focal uterine lesions in a saline conducting medium. 13,14 It soon became clear that these rapid and versatile electrosurgical approaches offered a wider repertoire of office treatments including treatment for fibroids, adhesions and uterine anomalies in addition to endometrial polyps 15 and have superseded mechanical approaches (Figure 1). Polyps within the uterus can be fibrous or glandular, pedunculated or sessile, single or multiple and vary in size from small with minimal uterine cavity distortion to large, filling the whole cavity. Location within the cavity can be a challenge especially fundally (due to difficulty accessing the base) or isthmically (due to restrictions of movement) sited lesions. Miniature hysteroscopic morcellators, which require a specific hysteroscope with an offset eyepiece, are the latest technologies to be introduced, e.g. TRUCLEAR TM (Figure 2) and MyoSure. They can be used in the outpatient setting to simultaneously remove and retrieve polyps and submucous fibroids 16 and appear to be especially useful in removing larger, fundally sited and multiple pathologies. Concerns over inability to establish histopathological diagnoses from morcellated specimens appear to be unfounded. 17 The techniques available for outpatient uterine polypectomy are summarised in Table 1. The current literature on these outpatient hysteroscopic techniques has demonstrated safety and feasibility, but evidence of effectiveness, patient acceptability and cost-effectiveness is lacking. 14,18 20 A multicentre randomised controlled trial (RCT) has randomised more than 500 women either to outpatient with or without local anaesthesia treatment or to day-case removal under general anaesthesia to compare effectiveness, cost-effectiveness and acceptability between ª 2013 Royal College of Obstetricians and Gynaecologists 161

4 Ambulatory hysteroscopy (a) (b) (c) Figure 1. Versapoint TM (Gynecare, Ethicon Inc., Menlo Park, CA, USA) bipolar electrosurgery system: generator, foot pedals (a), spring (b) and twizzle tipped electrodes (c). The chosen electrode is used down the 5 Fr working channel of a mm rigid 30 continuous flow hysteroscope or with the specifically designed alphascope (Gynecare, Ethicon Inc., Menlo Park, CA, USA) with a total outer diameter of less than 5 mm. All images reproduced with permission from Ethicon Inc. treatment settings. 21 These patients, as well as 400 nonrandomised additional women who expressed a definite preference for treatment setting, will also allow effectiveness and acceptability of treatments to be compared according to type of abnormal bleeding, menopausal status and treatment technique. In time, therefore, we should have more idea as to how best to treat uterine polyps and whom we should treat. Fibroids Submucous fibroids are commonly found in association with menstrual and reproductive problems. Can we remove them hysteroscopically both safely and in entirety or do we offer repeat treatments? Do we need to prepare the endometrium with associated cost and morbidity? Do we need to remove the whole fibroid or just normalise the contour of the uterine cavity (allowing any residual fibroid to spontaneously extrude) reducing risk of inadvertent uterine perforation and visceral injury? Appropriate diagnostic work-up and consideration of patient views are key to choosing how best to approach the management of uterine fibroids. The removal of most intracavity fibroids requires general anaesthetic and often larger diameter hysteroscopes with their (a) (b) Figure 2. The TRUCLEAR TM hysteroscopic morcellator (a; Smith & Nephew Inc., Andover, MA, USA): Hysteroscope showing off-set eyepiece and morcellator (b). The mechanical morcellator is attached to external suction allowing simultaneous cutting and tissue extraction. All images reproduced with permission from Smith & Nephew Inc. associated advantages of better visualisation with improved illumination and efficient continuous flow systems as well as easier removal of treated fibroid tissue. However, it is not uncommon for failed removal of polyps under general anaesthetic by curettage to be subsequently removed in the outpatient setting by excising these misdiagnosed grade 0 fibroids using bipolar electrosurgery. 22 Smaller, sessile fibroids can also be ablated in the office setting. Even if, for most submucous fibroids, larger diameter resectoscopes are optimal, outpatient hysteroscopic assessment is key; it allows an assessment of treatment setting and need for endometrial preparation, based upon the size, vascularity, number and location of myomas, to be assessed. The role of preliminary incision of the capsule of mucosa overlying the submucous fibroid precipitating expulsion of the fibroid into the uterine cavity (e.g. changing a grade 1 to a grade 0 submucous fibroid, 23 thereby preparing the fibroid for subsequent resection under general anaesthesia, is unclear. Adhesions, septae and hypoplastic uteri adhesiolysis can be achieved with scissors or Versapoint TM diathermy in an outpatient setting where scar tissue is filmy and cavity distortion minimal. 24 However, published data are lacking for the safety and feasibility of plastic operations on the uterus in an outpatient, local anaesthetic setting. Endometrial ablation The development of second-generation miniature, semiautomated ablative technologies has allowed the concept of outpatient local anaesthetic endometrial ablation to be progressed. In the few centres able to offer both treatment environments, outpatient local anaesthetic ablation is as popular as traditional day-case general anaesthetic settings. 25 Several observational studies have addressed the feasibility of outpatient local anaesthetic ablation for various technologies: HydroThermAblator System (Boston Scientific Corp., Natick, MA, USA), 26 Thermachoice Endometrial Ablation (TEA; Gynecare Inc., Somerville, NJ, USA), 27,28 Thermablate 162 ª 2013 Royal College of Obstetricians and Gynaecologists

5 Cooper and Clark Table 1. Techniques for outpatient hysteroscopic polypectomy Comment Technique and instruments Removal Retrieval Advantage Disadvantage Blind Mechanical (ring polyp forceps/curette) Hybrid forceps + ring polyp forceps or curette scissors + ring polyp forceps or curette bipolar electrosurgery + ring polyp forceps or curette forceps or polyp snare scissors + forceps or polyp snare bipolar electrosurgery + forceps or polyp snare polyp snare monopolar current Blind avulsion Simultaneous Cheap: does not require sophisticated instrumentation; suitable for large, pedunculated, fundal lesions avulsion avulsion/ morcellator morcellation Blind location Useful for removing large, fibrous polyps and where there is a narrow internal cervical os Painful; requires LA and cervical dilatation; risks uterine perforation and failure to locate the pathology Requires LA and cervical dilatation Blind location Useful for where there is a narrow internal cervical os Requires LA and cervical dilatation. Manipulating scissors difficult at uterine cornu and with larger, fibrous lesions. Bleeding may obscure view Blind location Useful for removing large, fibrous polyps and where there is a narrow internal cervical os Simultaneous hysteroscopic Simultaneous hysteroscopic Simultaneous hysteroscopic Quick, avoids LA, allows vaginoscopic approach. Costs minimal especially with graspers alone Quick, avoids LA, allows vaginoscopic approach. Costs minimal especially with graspers alone Quick, avoids LA, allows vaginoscopic approach. Rapid, bloodless and suitable for fibrous as well as glandular, vascular lesions Avoids LA, allows vaginoscopic approach. Suitable for fibrous as well as glandular lesions Avoids LA, allows vaginoscopic approach. Suitable for all types of polyp including fundal large fibrous and pedunculated polyp and multiple lesions Requires LA and cervical dilatation. Disposable electrodes more expensive than reusable mechanical instruments Not always possible to remove larger, fibrous polyps through a narrow cervical os. Bleeding may obscure view Not always possible to remove larger, fibrous polyps through a narrow cervical os. Manipulating scissors difficult at uterine cornu. Bleeding may obscure view Not always possible to remove larger, fibrous polyps through a narrow cervical os. Costs of disposable electrode Snaring larger lesions en bloc can be difficult. Needs return electrode plate + non-conducting fluid medium if monopolar energy applied. Costs of disposable snare Needs its own specific hysteroscope with an offset eyepiece. Costs of disposable morcellator LA = local anaesthesia The choice of approach depends in part upon the availability of equipment but also is dictated by the size, number, type and location of the focal pathology ª 2013 Royal College of Obstetricians and Gynaecologists 163

6 Ambulatory hysteroscopy EAS TM (Idoman Ltd, Dublin, Ireland), 29 NovaSure bipolar system (RFA) (Hologic, Marlborough, MA, USA). 30 There are also some RCTs comparing outpatient local anaesthetic ablation with day-case inpatient general anaesthetic settings: TEA 31 and Microwave Endometrial Ablation (MEA) system (Microsulis Medical Ltd, Hampshire, UK). 32 For the first time an RCT has been conducted and published directly comparing two of the leading second generation ablative technologies in this novel outpatient local anaesthetic setting. 33 The COAT trial showed that both thermal balloon ablation using the TEA and radiofrequency impedance-controlled endometrial ablation using the RFA system were safe, acceptable and effective in this setting. The RFA procedure was significantly quicker, but no conclusive differences in pain or acceptability were identified between technologies. Rates of amenorrhoea were higher with RFA at all time points post-surgery compared with TEA, but these differences only reached statistical significance at 12 months in favour of RFA. There were no differences in health-related quality of life between treatment modalities but it was significantly improved following both treatments. Only one woman in each treatment arm had undergone a hysterectomy at 12 months. Whereas the majority of women undergoing the outpatient ablation would recommend it to a woman with a similar problem (82%), 13% of women found the procedure unacceptable. 33 We need to define more clearly the women most likely to have a positive and effective outpatient experience. In addition to selecting the right patients, we need also to concentrate our efforts on reducing procedurerelated pain by manipulating analgesic, anaesthetic (topical, intracervical and delayed paracervical blocks) and sedative regimens. 24 The use of intramyometrial injection of local anaesthesia under direct hysteroscopic guidance in the outpatient setting has been recently advocated, the so-called focal local. 34 sterilisation Outpatient hysteroscopic sterilisation offers women longterm, non-hormonal, effective, irreversible contraception without the need for surgical incisions or anaesthesia, thereby avoiding the small but significant risks of day-case, laparoscopic surgery. 35 Although it has long been recognised that the transcervical route to occluding the tubal ostia offers many potential advantages, it is only relatively recently that a technique has become established in clinical practice. The Essure permanent birth control system is now widely used across Europe, North America and Australasia with more than procedures being performed (Figure 3). The procedure involves placing a micro-insert, consisting of a stainless steel inner coil with polyester fibres and a superelastic nitinol outer anchoring coil, into the intramyometrial portion of each fallopian tube. This is done via a fine delivery catheter which is passed down the 5 Fr operating channel of a mm continuous flow rigid hysteroscope. The procedure can be performed in the majority of women vaginoscopically using normal saline distension, without local anaesthesia and is completed in 5 10 minutes. The majority of women are discharged home within 1 hour. 36 Occlusion of the narrow tubal lumen takes up to 3 months as the polyester fibres cause an inflammatory reaction with tissue ingrowth into the micro-insert and subsequent blockage of the fallopian tube. Confirmatory radiology is scheduled at 3 months to confirm the adequacy of sterilisation; satisfactory device placement is checked by abdominal X-ray or transvaginal ultrasound scan in the 85% of procedures considered straightforward, and the remainder undergo more invasive hysterosalpingogram to confirm tubal occlusion. 37 In the last decade since its introduction, the feasibility, 36,38 as well as the qualitative 39 and economic 40,41 benefits, of hysteroscopic sterilisation using the Essure system have been widely demonstrated. Women must be informed to continue using additional contraception until the results of radiological testing are available. Successful bilateral device placement rates vary but are consistently >90% and in many centres >95% 36,41 43 for techniques. No pregnancies have been reported from the (a) (b) Figure 3. The Essure â (Conceptus Inc., Mountain View, CA, USA) hysteroscopic sterilisation system: Hand piece, delivery system (a) and micro-insert (b). All images reproduced with permission from Conceptus Inc. 164 ª 2013 Royal College of Obstetricians and Gynaecologists

7 Cooper and Clark original pivotal trial of Essure 43 and the effectiveness of the Essure system is reported to be better than laparoscopic sterilisation 44 with 5-year success rate of 99.7% from the literature 45 supported by data from commercial use (748 pregnancies reported/ kits distributed worldwide; 99.9%) 46 although the latter is likely to be an underestimate. Longer term data pertaining to cumulative pregnancy rates and complications are needed for the Essure technology to allow a fair comparison against laparoscopic approaches. Conclusions Outpatient hysteroscopy confers many advantages over daycase procedures including safety, efficiency, convenience, and cost-effectiveness. 24,47,48 In the UK in 2010, a total of diagnostic hysteroscopies were performed under general anaesthetic, representing 70% of all diagnostic hysteroscopies. This anachronistic 7:3 ratio needs addressing urgently with investment in ambulatory infrastructure and training, and change in mentality of practising clinicians. An 80% outpatient target for all diagnostic hysteroscopies performed as primary procedures should become mandatory and a 90% target is readily achievable with the correct referral pathways and infrastructures in place. As evidence supporting outpatient intervention accumulates, it is likely that funding of health services will incentivise best practice and drive necessary changes in service delivery. In addition to simple diagnostic procedures, there is mounting evidence to support the use of outpatient therapeutic procedures, namely removal of focal uterine anomalies, 14,49 LNG-IUS insertion and, endometrial ablation, and female sterilisation. 36,42 Further publications from major trials in this field are expected to energise the expansion of ambulatory hysteroscopic services, which appear to be underdeveloped in most UK units. The recent RCOG report examining the future delivery of obstetrics and gynaecology 50 recommended devolving some traditional aspects of gynaecological practice to a community-based setting. Those hospitals with established or developing ambulatory diagnostic and therapeutic hysteroscopy services will be in a position to engage and collaborate with local Primary Care Trusts (PCTs) for optimising gynaecological service delivery. By contrast, those hospitals neglecting such services will become vulnerable to losing substantial parts of their traditional gynaecological patient referral base. Evidence, economics and politics demonstrate that now is the time to engage in outpatient see and treat hysteroscopy. Disclosure of interests N.A.M. Cooper: none declared. T. J. Clark is a consultant to Conceptus. He received an honoraria from Hologic and Ethicon for clinician training which has been paid into a charitable account to fund research. He has also received an honoraria for lecturing from Nordic Pharma. He has received trial funding from Hologic and is currently a member of their European Advisory Board. He has received funding for travel and accommodation at national and international conferences from Ethicon, Hologic and Conceptus. He receives research funding from the Department of Health and is an HTA Programme Elected West-Midlands member. References 1 Royal College of Obstetricians and Gynaecologists. Best Practice in Outpatient Hysteroscopy. London: RCOG; Sinha S, Madari S, Al-Shabibi N, Papalampros P, Papadimitriou A, Tirlapur S, et al. The H Pipelle: no touch biopsy at no touch hysteroscopy. Int J Gynecol Obstet 2009;107:S Madari S, Al-Shabibi N, Papalampros P, Papadimitriou A, Magos A. A randomised trial comparing the H Pipelle with the standard Pipelle for endometrial sampling at no-touch (vaginoscopic) hysteroscopy. BJOG 2009;116: Cooper NA, Smith P, Khan KS, Clark TJ. Vaginoscopic approach to outpatient hysteroscopy: a systematic review of the effect on pain. BJOG 2010;117: Clark TJ, Mann CH, Shah N, Khan KS, Song F, Gupta JK. Accuracy of outpatient endometrial biopsy in the diagnosis of endometrial cancer: a systematic quantitative review. BJOG 2002;109: National Institute for Health and Clinical Excellence. CG44. Heavy Menstrual Bleeding: NICE Guideline London: NICE; Clark TJ. Cost-Effectiveness of Diagnostic Strategies for the Management of Abnormal Uterine Bleeding (Heavy Menstrual Bleeding and Post-menopausal Bleeding): Systematic Reviews, IPD Meta-analysis and Model Based Economic Evaluation. London: National Institute for Health Research [ asp]. 8 Nathani F, Clark TJ. Uterine polypectomy in the management of abnormal uterine bleeding: a systematic review. J Minim Invasive Gynecol 2006;13: Lieng M, Istre O, Qvigstad E. Treatment of endometrial polyps: a systematic review. Acta Obstet Gynecol Scand 2010;89: Lee SC, Kaunitz AM, Sanchez-Ramos L, Rhatigan RM. The oncogenic potential of endometrial polyps: a systematic review and metaanalysis. Obstet Gynecol 2010;116: Ben-Arie A, Goldchmit C, Laviv Y, Levy R, Caspi B, Huszar M, et al. The malignant potential of endometrial polyps. Eur J Obstet Gynecol Reprod Biol 2004;115: Bettocchi S, Ceci O, Nappi L, Di R, Masciopinto V, Pansini V, et al. Operative office hysteroscopy without anesthesia: analysis of 4863 cases performed with mechanical instruments. J Am Assoc Gynecol Laparosc 2004;11: Kung RC, Vilos GA, Thomas B, Penkin P, Zoltz AP, Stabinsky SA. A new bipolar system for performing operative hysteroscopy in normal saline. J Am Assoc Gynecol Laparosc 1999;6: Clark TJ, Godwin J, Khan KS, Gupta JK. Ambulatory endoscopic treatment of symptomatic benign endometrial polyps: a feasibility study. Gynaecol Endosc 2002;11: Clark TJ. Outpatient hysteroscopy and ultrasonography in the management of endometrial disease. Curr Opin Obstet Gynecol 2004;16: Lukes AS. Myosure tissue removal system comparative sedation study in an office setting. J Minim Invasive Gynecol 2010;17(Suppl 1): S Alhilli MM, Nixon KE, Hopkins MR, Weaver AL, Laughlin-Tommaso SK, Famuyide AO. Long-term outcomes after intrauterine morcellation vs ª 2013 Royal College of Obstetricians and Gynaecologists 165

8 Ambulatory hysteroscopy hysteroscopic resection of endometrial polyps. J Minim Invasive Gynecol 2013;20: Marsh F, Kremer C, Duffy S. Delivering an effective outpatient service in gynaecology. A randomised controlled trial analysing the cost of outpatient versus daycase hysteroscopy. BJOG 2004;111: Capobianco G, Vargiu N, Dessole F, Milia L, Dessole S. Office hysteroscopy for uterine intracavitary pathologies: see and treat approach. Gynecol Surg 2009;6:S1 S Timmermans A, Veersema S. Ambulatory transcervical resection of polyps with the Duckbill polyp snare: a modality for treatment of endometrial polyps. J Minim Invasive Gynecol 2005;12: Clark TJ, Daniels J, Gray R, Denny E, Roberts T. A Randomised Controlled Trial of Outpatient Polyp Treatment for Abnormal Uterine Bleeding. Centre for Reviews and Dissemination; 2010 [ dx.doi.org/ /isrctn ]. 22 Clark TJ, Mahajan D, Sunder P, Gupta JK. treatment of symptomatic submucous fibroids using a bipolar intrauterine system: a feasibility study. Eur J Obstet Gynecol Reprod Biol 2002;100: A Di Spiezio Sardo, personal communication. 24 Clark TJ, Gupta JK. Handbook of Outpatient Hysteroscopy. A Complete Guide to Diagnosis and Therapy. 1st ed. London: Hodder Education; TJ Clark, personal communication. 26 Farrugia M, Hussain SY. endometrial ablation using the HydroThermAblator in an outpatient hysteroscopy clinic: feasibility and acceptability. J Minim Invasive Gynecol 2006;13: Clark TJ, Gupta JK. Outpatient thermal balloon ablation of the endometrium. Fertil Steril 2004;82: Varma R, Soneja H, Samuel N, Sangha E, Clark TJ, Gupta JK. Outpatient thermachoice endometrial balloon ablation: long-term, prognostic and quality-of-life measures. Gynecol Obstet Invest 2010;70: Prasad P, Powell MC. Outpatients Thermablate EAS. A global thermal endometrial balloon ablation for menorrhagia. A retrospective review. Gynecol Surg 2009;6:S1 S Kalkat RK, Cartmill RSV. NovaSure endometrial ablation under local anaesthesia in an outpatient setting: an observational study. J Obstet Gynaecol 2011;31: Marsh F, Thewlis J, Duffy S. Randomized controlled trial comparing Thermachoice III* in the outpatient versus daycase setting. Fertil Steril 2007;87: Jack SA, Cooper KG, Seymour J, Graham W, Fitzmaurice A, Perez J. A randomised controlled trial of microwave endometrial ablation without endometrial preparation in the outpatient setting: patient acceptability, treatment outcome, and costs. Obstet Gynecol Surv 2005;60: Clark TJ, Samuel N, Malick S, Middleton LJ, Daniels J, Gupta JK. Bipolar radiofrequency compared with thermal balloon endometrial ablation in the office: a randomized controlled trial. Obstet Gynecol 2011;117: Skensved H. Global local anaesthesia: combining paracervical block with intramyometrial prilocaine in the fundus significantly reduces patients perception of pain during radio-frequency endometrial ablation (Novasure )inanoffice setting. Gynecol Surg 2012;2: Chapron C, Querleu D, Bruhat MA, Madelenat P, Fernandez H, Pierre F, et al. Surgical complications of diagnostic and operative gynaecological laparoscopy: a series of 29,966 cases. Hum Reprod 1998;13: Sinha D, Kalathy V, Gupta JK, Clark TJ. The feasibility, success and patient satisfaction associated with outpatient hysteroscopic sterilisation. Br J Obstet Gynaecol 2007;114: National Institute for Health and Clinical Excellence. Sterilisation by Tubal Cannulation and Placement of Intrafallopian Implants. London: NICE; 2009 [ 38 Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure pbc clinical study. Aust NZ J Obstet Gynaecol 2001;41: Baxter N, Hudson H, Rogerson L, Duffy S. sterilisation: a study of women s attitudes to a novel procedure. Br J Obstet Gynaecol 2005;112: Levie MD, Chudnoff SG. Office hysteroscopic sterilization compared with laparoscopic sterilization: a critical cost analysis. J Minim Invasive Gynecol 2005;12: Hurskainen R, Hovi SL, Gissler M, Grahn R, Kukkonen-Harjula K, Nord- Saari M, et al. tubal sterilization: a systematic review of the Essure system. Fertil Steril 2010;94: Arjona JE, Mino M, Cordon J, Povedano B, Pelegrin B, Castelo-Branco C. Satisfaction and tolerance with office hysteroscopic tubal sterilization. Fertil Steril 2008;90: Cooper JM, Carignan CS, Cher D, Kerin JF, Selective Tubal Occlusion Procedure 2000 Investigators Group. Microinsert nonincisional hysteroscopic sterilization. Obstet Gynecol 2003;102: Peterson HB, Xia Z, Hughes JM, Wilcox LS, Tylor LR, Trussell J. The risk of pregnancy after tubal sterilization: findings from the U.S. Collaborative Review of Sterilization. Am J Obstet Gynecol 1996;174: Bradley L. Long-term follow-up of hysteroscopic sterilization with the Essure micro-insert. J Minim Invasive Gynecol 2008;15 Suppl: S14 S Levy B, Veersema S, Munro M, Vleugels MPH. Reported pregnancies after Essure hysteroscopic sterilization: a retrospective analysis of pregnancy reports worldwide during commercial distribution: Gynecol Surg 2011;8 Suppl 1:S71. [Abstract FC.13.8]. 47 Saridogan E, Tilden D, Sykes D, Davis N, Subramanian D. Cost-analysis comparison of outpatient see-and-treat hysteroscopy service with other hysteroscopy service models. J Minim Invasive Gynecol 2010;17: Kremer C, Duffy S, Moroney M. Patient satisfaction with outpatient hysteroscopy versus day case hysteroscopy: randomised controlled trial. BMJ 2000;320: Varma R, Soneja H, Clark TJ, Gupta JK. myomectomy for menorrhagia using Versascope bipolar system: efficacy and prognostic factors at a minimum of one year follow up. Eur J Obstet Gynecol Reprod Biol 2009;142: RCOG. High Quality Women s Health Care: A Proposal for Change. London: RCOG; 2011 [ HighQualityWomensHealthcareProposalforChange.pdf]. 166 ª 2013 Royal College of Obstetricians and Gynaecologists