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New developments in hysteroscopy
Best Practice & Research Clinical Obstetrics and Gynaecology 27 (2013) 421–429
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New developments in hysteroscopy Mark Hans Emanuel, MD, PhD, Gynaecologist * Department of Obstetrics and Gynaecology, Spaarne Ziekenhuis, Spaarnepoort 1, 2134TM Hoofddorp, The Netherlands
Keywords: hysteroscopy hysteroscopic sterilisation operative hysteroscopy resectoscopy hysteroscopic morcellation virtual hysteroscopy
Diagnostic and operative hysteroscopy have become standards in gynaecologic practice. Many hysteroscopic procedures have replaced old, invasive techniques, such as dilatation and curettage. As instruments have reduced in size, office hysteroscopy has begun to replace operating-room procedures. New instruments and techniques continue to emerge, and the prospects for improvement seem unlimited. Discussed are hysteroscopic sterilisation, bipolar electrosurgery, hysteroscopic morcellation, and virtual hysteroscopy. Furthermore, the evidence for supporting the vaginoscopic approach, cervical preparation, pain medication and the use of local anaesthetics is presented. Main hysteroscopic procedures, such as polypectomy, myomectomy, adhesiolysis, metroplasty, and the role of hysteroscopy before embryo transfer, are reviewed, and what has been proven is further discussed. Ó 2013 Published by Elsevier Ltd.
Introduction Hysteroscopy uses a transcervical approach to view and operate within the endometrial cavity. The basic instrument is a long, narrow telescope connected to a light source to illuminate the area to be viewed. With the woman in the lithotomy position, the cervix is viewed and the distal end of the telescope is passed into a cervical canal. The instrument is advanced into the uterine cavity. A camera is attached to the proximal end of the hysteroscope to broadcast the image onto a video monitor. Other common modifications are inflow and outflow tracts included in the shaft of the telescope for fluids to distend and irrigate the endometrial cavity. This enables the procedure to be viewed in an enlarged area. Hysteroscopy is a minimally invasive intervention that can be used to diagnose and treat many intrauterine and endocervical problems. Diagnostic hysteroscopy, tubal sterilisation, polypectomy and
* Tel.: þ31 238907563; Fax: þ31 238907541. E-mail address: [email protected]. 1521-6934/$ – see front matter Ó 2013 Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.bpobgyn.2012.11.005
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myomectomy are just a few of the commonly performed procedures. Given their safety and efficacy, diagnostic and operative hysteroscopy have become standards in gynaecologic practice. Over the past few decades, refinements in optic and fibre-optic technology, and inventions of new surgical accessories, have dramatically improved visual resolution and surgical techniques in hysteroscopy. Many hysteroscopic procedures have replaced old, invasive techniques, such as dilatation and curettage. As instruments have reduced in size, office hysteroscopy has begun to replace operating-room procedures. New instruments and techniques continue to emerge, and the prospects for improvement seem unlimited. Although the quality of clinical evidence for such improvements is still limited, an overview of what has been proven is provided here. Technology and instruments Hysteroscopes and sheaths The rigid, direct optical hysteroscope, which is derived from the cystoscope, uses fluid- or gasdistending media to obtain a wide-angle view of the uterine cavity. This hysteroscope takes advantage of a system of lenses and prisms to give the operator a well-illuminated image, with excellent contrast and resolution. The most widely used optical hysteroscopes have an outer diameter of 3–4 mm, but thinner rigid scopes with fibre optics and an outer diameter of 1.9 mm have been developed. Fibre-optic hysteroscopy was developed as a simple mechanism for viewing the uterine cavity with the use of gas as distending media. Fibre-optic hysteroscopy is inferior to the direct optical hysteroscopy for evaluating the uterine cavity because of a lower contrast and resolution of the images that are a composite of individual fibres. Both optical and fibre-optic hysteroscopes are monocular and provide little depth perception. They are available with different viewing angles, from 0–70 . Thirty-degree scopes are most commonly used for diagnostic procedures. Smaller angles of deflection are used in operative procedures. The hysteroscopes are easily attached to video-monitoring systems. The hysteroscope is inserted, securely fastened or permanently affixed into a metallic sleeve or sheath. Removable obturators are available for easy introduction of the sheath into the uterine cavity. Obturators are especially useful when dilatation is difficult or when large sheaths are being used. Diagnostic sheaths generally have an outer diameter between 2.5 and 5.5 mm, and operative sheaths have an outer diameter between 5.5 and 9.0 mm. Both diagnostic and operative sheaths are fitted with stopcocks or ports for the instillation of distending media. Modern diagnostic and operative sheaths have isolated, dual ports, and provide continuous laminar flow of distending media. Continuous flow with separated in- and outflow channels guarantees the optimal irrigation and imaging of the uterine cavity, and allows optimal intrauterine pressure and degree of cavity distension. In- and outflow can be regulated with separate stopcocks. Operative sheaths are designed to allow the passage of one or more operative instruments. A right-angle hysteroscope allows for direct insertion of rigid operating instruments; these sheaths have an outer diameter of 5–9 mm. New developments in hysteroscopes and sheaths were generally dominated by decreasing outer diameter without losing the quality of the image. Although newer hysteroscopes provide separate inand outflow channels, the inflow channel is often also designed as the working channel for the introduction of surgical instruments. In the case of a small outer diameter, the small fluid inflow channel can be mostly obstructed by the introduced instruments in such cases, causing impaired viewing. Therefore, further downsizing the outer diameter of hysteroscopes should not impair channel size further; more can be expected from the introduction of optical chip technology in hysteroscopes, such as the InvisioÒ Digital Hysteroscope (GyrusACMI/Olympus, Tokyo, Japan). Operative instruments and catheters An assortment of rigid, semi-rigid, and flexible instruments have been developed or adapted for hysteroscopic surgery. The rigid and semi-rigid instruments include scissors, grasping forceps, and biopsy forceps. Most instruments are inserted through an operating channel, which is often the
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combined inflow channel for fluid too. Special care should be taken when handling them, as the handle, shaft and tips can be easily damaged. Flexible, specifically adapted catheters, can also be inserted through the hysteroscopic sheath for tubal cannulation, selective chromopertubation, or for tubal sterilisation. The most commonly applied technique is the EssureÒ hysteroscopic sterilisation method (Conceptus, Mountain View CA, USA), which has been distributed for over 10 years. The system comprises two micro-inserts for intraluminal tubal occlusion, which are positioned using a disposable delivery system. Each micro-insert consists of a stainless steel inner coil, a nickel-titanium expanding outer coil, and polyethylene terephthalate fibres wound in and around the inner coil. When released from the delivery system, the outer coil expands to 1.5–2.0 mm in diameter to anchor the micro-insert in the variable diameters and shapes of the proximal fallopian tube. With hysteroscopic guidance, the micro-inserts are placed through the uterotubal junction to reach the more proximal portion of the Fallopian tube. The polyethylene terephthalate fibres incite local fibrocyte proliferation, resulting in luminal occlusion, typically within 3 months. Almost 500,000 women worldwide have been successfully sterilised with the technique, with an effectiveness at 5 years above 99.7% (data Conceptus, Mountain View CA, USA) One of the disadvantages of hysteroscopic techniques, compared with laparoscopic techniques, is that women need a specific reference test (e.g. transvaginal ultrasound or hysterosalpingography) after a few months before they can rely on an effective blocking of their tubes. Another disadvantage is that, in about 5% of women, successful bilateral occlusion at the first procedure is not possible; reasons for failure include inability to view or access the tubal ostia, expulsion, perforation, and malplacement (data Conceptus, Mountain View CA, USA) The clinician should discuss this possibility with the patient. Laparoscopic sterilisation or, alternatively, another attempt of EssureÒ placement, can be attempted at a later date. New developments in instruments and catheters are mainly related to hysteroscopic sterilisation. Recently, an alternative technique, AdianaÒ (Hologic, Bedford MA, USA), based on silicon ingrowth in the intramural tubal lumen after electrocautery, was launched and then withdrawn because of patent infringement problems and disappointing sales. The EssureÒ system has recently been improved further by introducing new catheters with better device-releasing properties. In the near future, techniques that immediately block the tubes, without the need for any reference tests, will be introduced for further clinical testing. A future indication for blocking the intramural part of the tubes will most likely include hydrosalpinges in combination with the need for in-vitro fertilisation (IVF) and intra-cytoplasmic sperm injection (ICSI).1 Resectoscope The hysteroscopic resectoscope is a modification of the urologic resectoscope. Its assembly requires practice and should be mastered before surgical procedures are undertaken. The sheath has an outer diameter of 7–9 mm, and includes both inflow and outflow ports for distending media. The resectoscope is equipped with continuous flow and provides excellent irrigation for operative procedures. If surgical debris or the so-called ‘chips’ block the operative field, the resectoscope can be removed while the sheath is left in place. This allows for removal of large tissue while maintaining cervical dilatation. Electrosurgical instruments or electrodes can be inserted into an attachment to a spring handle, which allows the surgeon to move the surgical electrode inward and outward. In cases of monopolar high-frequency electrosurgery, the woman must be grounded and a nonelectrolyte, non-conducting, distending medium must be used. The more modern bipolar resectoscopes are used with saline-distending media. Although bipolar techniques are less hazardous because of intravasation and electrolyte blood-imbalances, more gas-bubbles may hamper visualisation, and gas-emboli might even cause spasms in the lung capillaries, potentially disturbing gas diffusion in the lungs. New developments in resectoscopy are based on smaller outer diameter and bipolar electrosurgery. The use of bipolar techniques with saline irrigation and distention reduces the effects of fluid intravasation, as no electrolyte changes occur. Fluid input and output should still also be monitored. If excessive intravasation occurs, the isotonic fluid overload is generally readily treatable with diuretics (e.g. furosemide 20 mg intravenously). Therefore, a higher amount of intravasation during surgery can be accepted. Generally, most protocols and guidelines mention about 2500 ml as the upper limit of saline intravasation.
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Electrocautery and laser Electrocautery instruments, such as a loop or needle electrode, roller ball, and button (or ‘mushroom’) electrode, have been adapted for the hysteroscope or resectoscope. Both the roller ball and the loop electrode can be used for endometrial ablation. In addition, the loop can be used for excision of submucous myomas, endometrial polyps, and the needle for the resection of uterine septa and small polyps. The button electrode is applied for coagulation of vessels or areas of endometrial lining. Bipolar electrodes are preferred nowadays, as they have the same less hazardous intravasation risks as resectoscopy with the use of saline for irrigation and distension of the cavity. Lasers (e.g. neodymium: yttrium–aluminum–garnet; potassium-titanyl-phosphate, and argon) offer no advantages over electrocoagulation. As these lasers are more expensive and more dangerous, the use of them has almost disappeared. No new significant developments have taken place in electrocautery instruments or lasers. The main disadvantage of bipolar compared with monopolar electrodes is the higher number of gasbubbles that are created and disturbing visibility. Although electrodes have improve, the problem has not been solved completely. Morcellation Tissue that has been cut must be removed from the uterine cavity by taking out the hysteroscope after grasping the loose tissue elements with forceps or the loop-electrode in the case of the resectoscope. Although the removal of tissue under visual control, instead of using a curette, is the most effective way, it takes a number of steps, which can be tiring in the long run, inconvenient to carry out, and consequently hard to learn. For these reasons, operative hysteroscopy has a long learning curve, and the number of gynaecologists that carry out operative hysteroscopy is still low. Therefore, alternative techniques are needed that are easier to learn and have less associated risks. The hysteroscopic morcellator could resolve some of the above-mentioned difficulties. I developed The TRUCLEARÔ (Smith and Nephew, Andover MA, USA) technique, which is based on an instrument that consists of a set of two metal hollow rigid tubes that fit into each other.2 The inner tube rotates within the outer tube, is driven mechanically by an electrically powered control unit, and is controlled by a foot pedal that activates the rotation and regulates the direction of rotation of the inner tube. The control unit is connected to a handheld motor drive unit in which the morcellator is inserted. Both tubes have a window-opening at the end with cutting edges. By means of a vacuum source connected to the inner tube, the tissue is sucked into the window-opening, cut and ‘shaved’ as the inner tube is rotated.2 The system uses no electrocoagulation, and there is no lateral thermal or electrical energy spread. Haemostasis occurs by spontaneous myometrial contraction. The removed tissue is discharged through the device, is collected in a tissue-trap, and is available for pathology analysis. As only one introduction is needed, the number of perforations is extremely low. The 4.0-mm morcellator is introduced in the uterine cavity through a straight-forward working-channel of a continuous flow 8–9 mm rigid hysteroscope. After dilatation of the internal orifice of the uterine cervix, atraumatic insertion is accomplished with the use of an obturator in the outer sheath of the hysteroscope. Saline solution is used for distension and irrigation. Van Dongen et al.3 conducted a randomised-controlled trial (RCT) to compare conventional resectoscopy and hysteroscopic morcellation among residents in training. The mean operating time for resectosocpy and morcellation was 17.0 (95% confidence interval [95% CI] 14.1 to 17.9, standard deviation (SD) 8.4) and 10.6 (95% CI 7.3 to 14.0, SD 9.5) mins, respectively (P ¼ 0.008). Subjective surgeon and trainer scores for convenience of technique on a visual analogue scale were in favour of the morcellator. A new development in hysteroscopic morcellation is the recent availability of a smaller outer diameter TRUCLEARÔ system, with a 2.9-mm cutting-blade and a 5.0-mm hysteroscope for office or ambulatory use with no or local anaesthesia. Polyps, small myomas, and retained products of pregnancy can be removed in that way. A new morcellator system MyoSureÒ was recently introduced by Hologic (Bedford MA, USA). A recent patent infringement US jury-verdict could jeopardise its future availability. Another company that recently introduced an alternative device is Storz (Tuttlingen, Germany).
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Distension and irrigation Carbon dioxide (CO2) is rapidly absorbed and easily cleared from the body by respiration. The gas easily flows through narrow channels in small-diameter scopes that can be used for office-based diagnostic hysteroscopy. This method, however, offers no way to clear blood from the scope. With CO2, a hysteroscopic insufflator is required to regulate flow and limit maximal intrauterine pressure. The advantage of fluid over gas is the symmetric distention of the uterus with fluid and its effective ability to flush blood, mucus, bubbles, and small tissue fragments out of the visual field. A pressure of 60–80 mm Hg is usually adequate for uterine distention with low viscosity fluids like saline. Various delivery systems are designed to suit the media used for uterine distention and to accurately record volumes of inflow and outflow. This recording is important because fluid can leave the uterus by means of a fluid outflow channel, a mechanical morcellator, cervical or tubal leakage, or intravasation. Hanging, gravity-fed containers to deliver fluid can be raised or compressed with a cuff; however, these can be unreliable in estimating intrauterine pressures. Pumps are available to monitor pressure and volume for liquid media. Media then usually flow into the uterine cavity through an inner sheath around the hysteroscope. A perforated outer sheath is used for collection or outflow of media. This design creates laminar flow, which keeps the visual field clear. Normal saline and lactated Ringer solution are isotonic, conductive, low-viscosity fluids, which can be used for diagnostic hysteroscopy and for mechanical and bipolar operative procedures. The hypotonic, non-conductive, low-viscosity fluids mannitol (5%), sorbitol (3–5%), and glycine (1.5%), should be used only with monopolar operative procedures. Absorption of large volumes of electrolyte-free, low-viscosity fluid may result in volume overload with water intoxication, pulmonary oedema, hyponatraemia, hypo-osmolarity, and cerebral oedema, but these are extremely rare in office procedures. Nausea and malaise are the earliest findings, and may be seen when the plasma sodium concentration falls to 5 mmol/l (this relates to an intravasation of 500 ml of electrolyte-free fluids). This may be followed by headache, lethargy, and obtundation, and eventually seizures, coma and respiratory arrest if the plasma sodium concentration falls between 10 and 15 mmol/l. New developments are the availability of newer fluid-management systems that are more reliable and precise in measuring in- and outflow fluids, and therefore improve patient safety. Furthermore, most improvements result in better ergonomy and, therefore, systems become less inconvenient for hospital staff. Virtual hysteroscopy During the past decade, transvaginal ultrasonography of the uterus has become a routine procedure in the diagnostic work-up of several gynaecological problems. A normal sonographic finding has been shown to be accurate for the exclusion of clinically significant intra-cavitary abnormalities.4 Furthermore, this normal sonographic finding is well reproduced in the hands of different examiners.5 In the case of abnormal or inconclusive sonographic findings, however, diagnostic accuracy and reproducibility decline. To improve the image in these cases, sonographic examination using artificial uterine cavity distension was first described at our department.6 Saline infusion sonohysterography (SIS) has been extensively described.7–9 It is accepted that SIS improves the diagnostic accuracy of transvaginal ultrasonography in cases of abnormal or inconclusive findings, and that SIS is an effective early diagnostic step in the evaluation of women with pre- and postmenopausal abnormal uterine bleeding. The only contraindications are pregnancy and pelvic infection. Although the visualisation of the uterine cavity and its linings improves significantly, women experience discomfort resulting from either fluid leakage, while using a catheter without a balloon, or pain with the use of a balloon catheter. In trying to overcome these disadvantages, and to create a more stable filling of the uterine cavity, we modified the technique of SIS by instilling gel instead of flushing or infusing saline. This new technique and first experiences of gel instillation sonohysterography (GIS) have been described.10 Three- and four-dimensional ultrasound images can only be achieved when stable and adequate distension of the uterine cavity is achieved. This can only be achieved by the use of gel. We use the term ‘virtual hysteroscopy’ for such type of imaging. Further improvement of ultrasound technology and computer
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processing will create images revealing diagnostic information that is equal to diagnostic hysteroscopy with comparable or less pain, inconvenience for the woman, or both. The latest development in this field is the method to change the gel during dilution into a stable foam that is fluid enough to pass patent tubes and can be observed as a white echodense contrast during transvaginal ultrasonography in cases of a fertility work-up (hysterosalpingo-foam sonography [HyFoSy]).11
Methods and procedures Preoperative preparation and basic introduction of the hysteroscope The woman is placed in the lithotomy position; skin, intravaginal or intracervical antiseptical measures are not required. Without the need of a speculum and a tenaculum, the hysteroscope can be inserted vaginoscopically into the cervix. The outflow stopcock of the sheath should always be open during insertion to prevent a sudden increase of intrauterine pressure, which is painful in most cases. The hysteroscope is put through the internal cervical orifice under direct endoscopic vision. Ideally, this is carried out with no, or minimal, cervical dilatation, but a tenaculum may be required. Cooper et al.12 examined the effect of a vaginoscopic approach to outpatient hysteroscopy on the patients’ experience of pain, compared with a traditional approach using a vaginal speculum and tenaculum in a metaanalysis of six RCTs (n ¼ 1321). They found that vaginoscopic approach to hysteroscopy was less painful than using the traditional technique (standardised mean difference (SMD) 0.44, 95% CI from 0.65 to 0.22). No significant difference was found in the number of failed procedures between groups. One should be aware that the angle of view of most hysteroscopes is 12–30 fore-oblique; this means that the deepest part of the front-lens of the hysteroscope is normally located at 6 o’clock, and this tip should therefore be located in the centre of the internal orifice during its passage. Although a video camera and monitor is not requisite, it is strongly recommended for the benefit of the surgeon and it is a useful teaching aid. Many women also like to observe the images during the procedure. Ogden et al.13 showed that viewing the screen had no effect on several measures of pain perception, mood, illness cognitions or communication. Women who did not see the screen were more optimistic about the effectiveness of their treatment. Studies examining the use of pharmaceutical (e.g. prostaglandins and antiprogestogens) and mechanical (e.g. osmotic dilators) dilatation of the cervix before hysteroscopy have produced conflicting results on their effect on cervical dilatation and trauma during the procedure. A recent meta-analysis14 of six RCTs examined women undergoing outpatient hysteroscopy. The intervention was the use of cervical preparation compared with a control or placebo. The outcome was pain assessment. No evidence was found to recommend the routine administration of mifepristone or misoprostol to women before outpatient hysteroscopy.14 Cervical priming with vaginal prostaglandins may be considered in postmenopausal women if using hysteroscopic systems greater than 5 mm in diameter. Hysteroscopy is increasingly performed as an outpatient procedure. The primary reason for failure is pain. No consensus exists on the routine use of analgesia during hysteroscopy. In a Cochrane review,15 24 RCTs involving 3155 participants investigated pharmacological interventions for pain relief during hysteroscopy. Meta-analysis (nine RCTs, 1296 participants) revealed a significant reduction in the mean pain score for the use of local anaesthetics during the procedure compared with placebo (SMD 0.45, 95% CI 0.73 to 0.17). Meta-analysis (four RCTs, 454 participants) showed a significant reduction in the mean pain score for the use of local anaesthetics within 30 mins after the procedure compared with placebo (SMD 0.51, 95% CI 0.81 to 0.21). No significant reduction was found in the mean pain score more than 30 mins after the procedure. No significant reduction was reported in the mean pain score with the use of non-steroidal anti-inflammatory drugs or opioid analgesics compared with placebo during, within, or more than 30 mins after the procedure. No significant difference was found between the number of incidents of failure to complete the procedure owing to cervical stenosis between the intervention and control groups (OR 1.31, 95% CI 0.66 to 2.59; six RCTs, 805 participants). Significantly fewer incidents of failure to complete the procedure were reported in the intervention group than in the control group owing to pain (OR 0.29, 95% CI 0.12 to 0.69; two studies, 330
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participants). Meta-analysis showed no significant difference in adverse effects between the intervention and placebo groups. Another systematic review and meta-analysis of 20 RCTs (2851 participants)16 showed that paracervical local anaesthetic injection is the best method of pain control for women undergoing hysteroscopy as outpatients, whereas transcervical and topical application did not show a statistical difference compared with placebo. A vasovagal syncope is usually, but not always, associated with a prodrome of dizziness, nausea, pallor or diaphoresis. Once the procedure has been completed, assumption of the supine position with legs raised or Trendelenburg position at the onset of such symptoms can be helpful. Some women may require atropine.
Operative procedures In this particular field of hysteroscopy, no specific recent new developments have taken place other than mechanical morcellation. Most procedures can be carried out as day surgery. One of the most important factors in carrying out operative hysteroscopy is maintenance of a clear operative field at the lowest intrauterine pressure. This can only be accomplished by the use of a sheath that provides continuous laminar flow of media. Whether the outflow tubing is connected to a vacuum-collecting system, or whether the outflow is passive, is a matter of taste. An accurate assessment of the fluid deficit and lost media in the drapes, towels, or on the operating room floor, ideally by a fluid management system, is mandatory during extensive operative procedures, such as resectoscopy. During diagnostic or minor operative procedures, fluid measurements are not that important, because the risk of intravasation is low during procedures that take only minutes to perform. The uterus is a vascular organ, and its vascularity may be enhanced by uterine myomas or other pathology. Intraoperative bleeding, however, is generally not a significant problem because a rapid liquid flow will clean the image and, after the procedure, uterine contractions will diminish bleeding rapidly. The risk of infection after operative hysteroscopy is low, thus prophylactic antibiotics are not routinely administered during operative procedures. The only RCT17 to study the effect of prophylactic antibiotics on the incidence of bacteraemia after hysteroscopic surgery showed no convincing evidence that antibiotics are of value. Because of its relative simple use and safety, second-generation endometrial ablation techniques have almost completely replaced classical hysteroscopical endometrial resection. Although hysteroscopic polypectomy seems to be effective in the treatment of heavy menstrual bleeding, this has not yet been proven in RCTs,18 and may never be proven because of the lack of participant recruitment. An example of such a failed study was published in 2009.19 If, during hysteroscopy, an endometrial polyp was diagnosed, patients were asked to participate in this trial; after securing informed consent, they were allocated to immediate removal of the polyp or expectant management. This trial suffered from lack of recruitment related to doctors seeking informed consent and patients’ unwillingness to participate in this trial. In other words, it seems that patients want pathology removed even without complaints. Another RCT on subfertility, showed an effect of polypectomy on chances of pregnancy in women scheduled for intrauterine insemination.20 Although international consensus exists about the need for hysteroscopic removal of submucous myomas in cases of heavy menstrual bleeding or subfertility, no RCTs have been conducted to date. Intrauterine adhesions (IUA) are rare and almost always preceded by pregnancy-related intrauterine procedures, such as miscarriage curettage or a puerperal curettage for placental remnants. Intrauterine adhesions never occur spontaneously. In cases of hypomenorrhea or amenorrhea, hysteroscopic treatment is necessary if the woman is wanting to become pregnant. No RCTs have been published on IUA or Asherman’s disease, so the different treatment modalities are based on individual experience. As the condition is so rare, looking for primary prevention measures seems irrational, as the number needed to treat will probably always be too high. The search for adequate measures to prevent recurrent adhesions (secondary prevention), however, seem logical, and trials, preferably randomised, are urgently needed.
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A septated uterus is often associated with recurrent miscarriages or early pregnancy loss. Implantation is thought to be compromised by an abnormal vascularisation of the endometrium covering the septum. Hysteroscopic metroplasty is advised, but this has never been evaluated properly. A national RCT is currently ongoing in The Netherlands (The Randomised Uterine Septum transsection Trial: TRUST).21 Woman who have experienced recurrent miscarriages (minimal two) are asked to participate. The two arms of the trial aim to compare hysteroscopic transsection of the septum immediately or transsection after the next pregnancy. The primary outcome measure is the course of the next pregnancy. According to the Dutch National Guidelines, metroplasty is not advised until TRUST Trial has been completed and evaluated. In two RCTs, the effect of hysteroscopic procedures before embryo transfer (ET) as part of IVF, ICSI, or both, was studied. In one study, 421 participants with two or more failed embryo transfers were randomised to one group who had undergone a previous hysteroscopy and one group who had not before the next ET.22 A total of 154 women had normal cavities and 56 had operative hysteroscopies for small pathologies. In the group without hysteroscopies, 21.6% conceived; in the group with hysteroscopy, 32.5% conceived; and in the group with operative hysteroscopy, 30.5% conceived (P ¼ 0.044). In a similar study with 520 participants, these figures were 26.2%, 44.4% and 39.6%, respectively (P < 0.05).23 As a possible explanation for these differences is thought of an easier cervical passage and therefore more efficacious ET after hysteroscopy or favourable immunological changes in the endometrium caused by the (minimal) trauma after the hysteroscopy. The ongoing Dutch INSIGHT RCT is also assessing the effect of hysteroscopy before ET.24 Postoperative care The woman may immediately resume normal activities if sedatives have not been administered, otherwise she should be driven home and refrain from strenuous activities and those requiring mental alertness. She should contact the surgeon if she develops fever, foul discharge, heavy bleeding, or persistent pain. Later on, imaging studies can be used to determine whether a particular procedure was successful (e.g. ultrasound, control hysteroscopy, or both). The appropriate timing for postoperative evaluation should be individualised, and is based upon the recurrence of symptoms, difficulty of the procedure, and needs of the patient. No RCTs have supported any specific postoperative measures. Conclusion New developments in instrumentation and techniques changed hysteroscopy into a diagnostic and therapeutic tool that can and should be used in every gynaecological practice. Especially the further improvement of instruments for office hysteroscopy changed the field of female sterilization and intrauterine surgery. The introduction of hysteroscopic morcellation opens the option of hysteroscopic surgery for the majority of patients without the need for extensive training and experience for the gynaecologists. The increasing number of RCT’s in this field are helpful in improving the quality of clinical performance of hysteroscopy and are increasing the chances of a favourable outcome for patients. Practice points Reducing the outer diameter of hysteroscopes have made it possible to replace procedures from the operating room to the office. Hydrosalpinges, in cases of IVF or ICSI, can effectively be blocked hysteroscopically. Hysteroscopic morcellation seems to be easier to learn and master than resectoscopy. Improvements of ultrasound technology and computer processing create images that increasingly resemble diagnostic hysteroscopy (virtual hysteroscopy). The vaginoscopic approach is tolerated better than the traditional approach in office hysteroscopy.
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Research agenda Measures for the secondary prevention of intrauterine adhesions should be investigated prospectively and randomised. The effect of hysteroscopic metroplasty on recurrent miscarriage and infertility should be investigated prospectively and randomised. The effect of hysteroscopy before embryo transfer on implantation rate should be investigated further prospectively and randomised.
References *1. Mijatovic V, Veersema S, Emanuel MH et al. Essure hysteroscopic tubal occlusion device for the treatment of hydrosalpinx prior to in vitro fertilization-embryo transfer in patients with a contraindication for laparoscopy. Fertil Steril 2010; 93: 1338–1342. *2. Emanuel MH & Wamsteker K. The intrauterine morcellator: a new hysteroscopic operating technique to remove intrauterine polyps and myomas. J Minim Invasive Gynecol 2005; 12: 62–66. *3. van Dongen H, Emanuel MH, Wolterbeek R et al. Hysteroscopic morcellator for removal of intrauterine polyps and myomas: a randomized controlled pilot study among residents in training. J Minim Invasive Gynecol 2008; 15: 466–471. 4. Emanuel MH, Verdel MJC, Wamsteker K et al. A prospective comparison of transvaginal ultrasonography and diagnostic hysteroscopy in the evaluation of patients with abnormal uterine bleeding; the clinical implications. Am J Obstet Gynaecol 1995; 172: 547–552. 5. Emanuel MH, Ankum WM, Verdel MJC et al. The reproducibility of transvaginal uterine ultrasound results in patients with abnormal uterine bleeding. Ultrasound Obstet Gynecol 1996; 8: 346–349. 6. van Roessel J, Wamsteker K & Exalto N. Sonographic investigation of the uterus during artificial uterine cavity distention. J Clin Ultrasound 1987; 15: 439–450. 7. Syrop CH & Sahakian V. Transvaginal sonographic detection of endometrial polyps with fluid contrast augmentation. Obstet Gynecol 1992; 79: 1041–1043. *8. Breitkopf D, Goldstein SR, Seeds JW, & ACOG Committee on Gynecologic Practice. ACOG technology assessment in obstetrics and gynecology. Number 3, September 2003. Saline infusion sonohysterography. Obstet Gynecol 2003; 102: 659–662. 9. de Kroon CD, de Bock GH, Dieben SW et al. Saline contrast hysterosonography in abnormal uterine bleeding: a systematic review and meta-analysis. Obstet Gynaecol Surv 2004; 59: 265–266. 10. Exalto N, Stappers C, van Raamsdonk LA et al. Gel instillation sonohysterography: first experience with a new technique. Fertil Steril 2007; 87: 152–155. *11. Emanuel MH, van Vliet M, Weber M et al. First experiences with hysterosalpingo-foam sonography (HyFoSy) for office tubal patency testing. Hum Reprod 2012; 27: 114–117. 12. Cooper NA, Smith P, Khan KS et al. Vaginoscopic approach to outpatient hysteroscopy: a systematic review of the effect on pain. BJOG 2010; 117: 532–539. 13. Ogden J, Heinrich M, Potter C et al. The impact of viewing a hysteroscopy on a screen on the patient’s experience: a randomised trial. BJOG 2009; 116: 286–292. 14. Cooper NA, Smith P, Khan KS et al. Does cervical preparation before outpatient hysteroscopy reduce women’s pain experience? A systematic review. BJOG 2011; 118: 1292–1301. 15. Ahmad G, O’Flynn H, Attarbashi S et al. Pain relief for outpatient hysteroscopy. Cochrane Database Syst Rev 2010; 11. CD007710. *16. Cooper NA, Khan KS & Clark TJ. Local anaesthesia for pain control during outpatient hysteroscopy: systematic review and meta-analysis. BMJ 2010; 340: c1130. 17. Bhattacharya S, Parkin DE, Reid TM et al. A prospective randomised study of the effects of prophylactic antibiotics on the incidence of bacteraemia following hysteroscopic surgery. Eur J Obstet Gynecol Reprod Biol 1995; 63: 37–40. *18. Lieng M, Istre O & Qvigstad E. Treatment of endometrial polyps: a systematic review. Acta Obstet Gynecol Scand 2010; 89: 992–1002. 19. Timmermans A, Veersema S, van Kerkvoorde TC et al. Should endometrial polyps be removed in patients with postmenopausal bleeding? An assessment of study designs and report of a failed randomised controlled trial. BJOG 2009; 116: 1391–1395. *20. Pérez-Medina T, Bajo-Arenas J, Salazar F et al. Endometrial polyps and their implication in the pregnancy rates of patients undergoing intrauterine insemination: a prospective, randomized study. Hum Reprod 2005; 20: 1632–1635. *21. Kowalik CR, Goddijn M, Emanuel MH et al. Metroplasty versus expectant management for women with recurrent miscarriage and a septate uterus. Cochrane Database Syst Rev 2011; 6. CD008576. *22. Demirol A & Gurgan T. Effect of treatment of intrauterine pathologies with office hysteroscopy in patients with recurrent IVF failure. Reprod Biomed Online 2004; 5: 590–594. 23. Rama Raju GA, Shashi Kumari G, Krishna KM et al. Assessment of uterine cavity by hysteroscopy in assisted reproduction programme and its influence on pregnancy outcome. Arch Gynecol Obstet 2006; 274: 160–164. 24. Smit JG, Kasius JC, Eijkemans MJ et al. The inSIGHT study: costs and effects of routine hysteroscopy prior to a first IVF treatment cycle. A randomised controlled trial. BMC Womens Health 2012; 12: 22.
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Best Practice & Research Clinical Obstetrics and Gynaecology journal homepage: www.elsevier.com/locate/bpobgyn
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New developments in hysteroscopy Mark Hans Emanuel, MD, PhD, Gynaecologist * Department of Obstetrics and Gynaecology, Spaarne Ziekenhuis, Spaarnepoort 1, 2134TM Hoofddorp, The Netherlands
Keywords: hysteroscopy hysteroscopic sterilisation operative hysteroscopy resectoscopy hysteroscopic morcellation virtual hysteroscopy
Diagnostic and operative hysteroscopy have become standards in gynaecologic practice. Many hysteroscopic procedures have replaced old, invasive techniques, such as dilatation and curettage. As instruments have reduced in size, office hysteroscopy has begun to replace operating-room procedures. New instruments and techniques continue to emerge, and the prospects for improvement seem unlimited. Discussed are hysteroscopic sterilisation, bipolar electrosurgery, hysteroscopic morcellation, and virtual hysteroscopy. Furthermore, the evidence for supporting the vaginoscopic approach, cervical preparation, pain medication and the use of local anaesthetics is presented. Main hysteroscopic procedures, such as polypectomy, myomectomy, adhesiolysis, metroplasty, and the role of hysteroscopy before embryo transfer, are reviewed, and what has been proven is further discussed. Ó 2013 Published by Elsevier Ltd.
Introduction Hysteroscopy uses a transcervical approach to view and operate within the endometrial cavity. The basic instrument is a long, narrow telescope connected to a light source to illuminate the area to be viewed. With the woman in the lithotomy position, the cervix is viewed and the distal end of the telescope is passed into a cervical canal. The instrument is advanced into the uterine cavity. A camera is attached to the proximal end of the hysteroscope to broadcast the image onto a video monitor. Other common modifications are inflow and outflow tracts included in the shaft of the telescope for fluids to distend and irrigate the endometrial cavity. This enables the procedure to be viewed in an enlarged area. Hysteroscopy is a minimally invasive intervention that can be used to diagnose and treat many intrauterine and endocervical problems. Diagnostic hysteroscopy, tubal sterilisation, polypectomy and
* Tel.: þ31 238907563; Fax: þ31 238907541. E-mail address: [email protected]. 1521-6934/$ – see front matter Ó 2013 Published by Elsevier Ltd. http://dx.doi.org/10.1016/j.bpobgyn.2012.11.005
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myomectomy are just a few of the commonly performed procedures. Given their safety and efficacy, diagnostic and operative hysteroscopy have become standards in gynaecologic practice. Over the past few decades, refinements in optic and fibre-optic technology, and inventions of new surgical accessories, have dramatically improved visual resolution and surgical techniques in hysteroscopy. Many hysteroscopic procedures have replaced old, invasive techniques, such as dilatation and curettage. As instruments have reduced in size, office hysteroscopy has begun to replace operating-room procedures. New instruments and techniques continue to emerge, and the prospects for improvement seem unlimited. Although the quality of clinical evidence for such improvements is still limited, an overview of what has been proven is provided here. Technology and instruments Hysteroscopes and sheaths The rigid, direct optical hysteroscope, which is derived from the cystoscope, uses fluid- or gasdistending media to obtain a wide-angle view of the uterine cavity. This hysteroscope takes advantage of a system of lenses and prisms to give the operator a well-illuminated image, with excellent contrast and resolution. The most widely used optical hysteroscopes have an outer diameter of 3–4 mm, but thinner rigid scopes with fibre optics and an outer diameter of 1.9 mm have been developed. Fibre-optic hysteroscopy was developed as a simple mechanism for viewing the uterine cavity with the use of gas as distending media. Fibre-optic hysteroscopy is inferior to the direct optical hysteroscopy for evaluating the uterine cavity because of a lower contrast and resolution of the images that are a composite of individual fibres. Both optical and fibre-optic hysteroscopes are monocular and provide little depth perception. They are available with different viewing angles, from 0–70 . Thirty-degree scopes are most commonly used for diagnostic procedures. Smaller angles of deflection are used in operative procedures. The hysteroscopes are easily attached to video-monitoring systems. The hysteroscope is inserted, securely fastened or permanently affixed into a metallic sleeve or sheath. Removable obturators are available for easy introduction of the sheath into the uterine cavity. Obturators are especially useful when dilatation is difficult or when large sheaths are being used. Diagnostic sheaths generally have an outer diameter between 2.5 and 5.5 mm, and operative sheaths have an outer diameter between 5.5 and 9.0 mm. Both diagnostic and operative sheaths are fitted with stopcocks or ports for the instillation of distending media. Modern diagnostic and operative sheaths have isolated, dual ports, and provide continuous laminar flow of distending media. Continuous flow with separated in- and outflow channels guarantees the optimal irrigation and imaging of the uterine cavity, and allows optimal intrauterine pressure and degree of cavity distension. In- and outflow can be regulated with separate stopcocks. Operative sheaths are designed to allow the passage of one or more operative instruments. A right-angle hysteroscope allows for direct insertion of rigid operating instruments; these sheaths have an outer diameter of 5–9 mm. New developments in hysteroscopes and sheaths were generally dominated by decreasing outer diameter without losing the quality of the image. Although newer hysteroscopes provide separate inand outflow channels, the inflow channel is often also designed as the working channel for the introduction of surgical instruments. In the case of a small outer diameter, the small fluid inflow channel can be mostly obstructed by the introduced instruments in such cases, causing impaired viewing. Therefore, further downsizing the outer diameter of hysteroscopes should not impair channel size further; more can be expected from the introduction of optical chip technology in hysteroscopes, such as the InvisioÒ Digital Hysteroscope (GyrusACMI/Olympus, Tokyo, Japan). Operative instruments and catheters An assortment of rigid, semi-rigid, and flexible instruments have been developed or adapted for hysteroscopic surgery. The rigid and semi-rigid instruments include scissors, grasping forceps, and biopsy forceps. Most instruments are inserted through an operating channel, which is often the
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combined inflow channel for fluid too. Special care should be taken when handling them, as the handle, shaft and tips can be easily damaged. Flexible, specifically adapted catheters, can also be inserted through the hysteroscopic sheath for tubal cannulation, selective chromopertubation, or for tubal sterilisation. The most commonly applied technique is the EssureÒ hysteroscopic sterilisation method (Conceptus, Mountain View CA, USA), which has been distributed for over 10 years. The system comprises two micro-inserts for intraluminal tubal occlusion, which are positioned using a disposable delivery system. Each micro-insert consists of a stainless steel inner coil, a nickel-titanium expanding outer coil, and polyethylene terephthalate fibres wound in and around the inner coil. When released from the delivery system, the outer coil expands to 1.5–2.0 mm in diameter to anchor the micro-insert in the variable diameters and shapes of the proximal fallopian tube. With hysteroscopic guidance, the micro-inserts are placed through the uterotubal junction to reach the more proximal portion of the Fallopian tube. The polyethylene terephthalate fibres incite local fibrocyte proliferation, resulting in luminal occlusion, typically within 3 months. Almost 500,000 women worldwide have been successfully sterilised with the technique, with an effectiveness at 5 years above 99.7% (data Conceptus, Mountain View CA, USA) One of the disadvantages of hysteroscopic techniques, compared with laparoscopic techniques, is that women need a specific reference test (e.g. transvaginal ultrasound or hysterosalpingography) after a few months before they can rely on an effective blocking of their tubes. Another disadvantage is that, in about 5% of women, successful bilateral occlusion at the first procedure is not possible; reasons for failure include inability to view or access the tubal ostia, expulsion, perforation, and malplacement (data Conceptus, Mountain View CA, USA) The clinician should discuss this possibility with the patient. Laparoscopic sterilisation or, alternatively, another attempt of EssureÒ placement, can be attempted at a later date. New developments in instruments and catheters are mainly related to hysteroscopic sterilisation. Recently, an alternative technique, AdianaÒ (Hologic, Bedford MA, USA), based on silicon ingrowth in the intramural tubal lumen after electrocautery, was launched and then withdrawn because of patent infringement problems and disappointing sales. The EssureÒ system has recently been improved further by introducing new catheters with better device-releasing properties. In the near future, techniques that immediately block the tubes, without the need for any reference tests, will be introduced for further clinical testing. A future indication for blocking the intramural part of the tubes will most likely include hydrosalpinges in combination with the need for in-vitro fertilisation (IVF) and intra-cytoplasmic sperm injection (ICSI).1 Resectoscope The hysteroscopic resectoscope is a modification of the urologic resectoscope. Its assembly requires practice and should be mastered before surgical procedures are undertaken. The sheath has an outer diameter of 7–9 mm, and includes both inflow and outflow ports for distending media. The resectoscope is equipped with continuous flow and provides excellent irrigation for operative procedures. If surgical debris or the so-called ‘chips’ block the operative field, the resectoscope can be removed while the sheath is left in place. This allows for removal of large tissue while maintaining cervical dilatation. Electrosurgical instruments or electrodes can be inserted into an attachment to a spring handle, which allows the surgeon to move the surgical electrode inward and outward. In cases of monopolar high-frequency electrosurgery, the woman must be grounded and a nonelectrolyte, non-conducting, distending medium must be used. The more modern bipolar resectoscopes are used with saline-distending media. Although bipolar techniques are less hazardous because of intravasation and electrolyte blood-imbalances, more gas-bubbles may hamper visualisation, and gas-emboli might even cause spasms in the lung capillaries, potentially disturbing gas diffusion in the lungs. New developments in resectoscopy are based on smaller outer diameter and bipolar electrosurgery. The use of bipolar techniques with saline irrigation and distention reduces the effects of fluid intravasation, as no electrolyte changes occur. Fluid input and output should still also be monitored. If excessive intravasation occurs, the isotonic fluid overload is generally readily treatable with diuretics (e.g. furosemide 20 mg intravenously). Therefore, a higher amount of intravasation during surgery can be accepted. Generally, most protocols and guidelines mention about 2500 ml as the upper limit of saline intravasation.
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Electrocautery and laser Electrocautery instruments, such as a loop or needle electrode, roller ball, and button (or ‘mushroom’) electrode, have been adapted for the hysteroscope or resectoscope. Both the roller ball and the loop electrode can be used for endometrial ablation. In addition, the loop can be used for excision of submucous myomas, endometrial polyps, and the needle for the resection of uterine septa and small polyps. The button electrode is applied for coagulation of vessels or areas of endometrial lining. Bipolar electrodes are preferred nowadays, as they have the same less hazardous intravasation risks as resectoscopy with the use of saline for irrigation and distension of the cavity. Lasers (e.g. neodymium: yttrium–aluminum–garnet; potassium-titanyl-phosphate, and argon) offer no advantages over electrocoagulation. As these lasers are more expensive and more dangerous, the use of them has almost disappeared. No new significant developments have taken place in electrocautery instruments or lasers. The main disadvantage of bipolar compared with monopolar electrodes is the higher number of gasbubbles that are created and disturbing visibility. Although electrodes have improve, the problem has not been solved completely. Morcellation Tissue that has been cut must be removed from the uterine cavity by taking out the hysteroscope after grasping the loose tissue elements with forceps or the loop-electrode in the case of the resectoscope. Although the removal of tissue under visual control, instead of using a curette, is the most effective way, it takes a number of steps, which can be tiring in the long run, inconvenient to carry out, and consequently hard to learn. For these reasons, operative hysteroscopy has a long learning curve, and the number of gynaecologists that carry out operative hysteroscopy is still low. Therefore, alternative techniques are needed that are easier to learn and have less associated risks. The hysteroscopic morcellator could resolve some of the above-mentioned difficulties. I developed The TRUCLEARÔ (Smith and Nephew, Andover MA, USA) technique, which is based on an instrument that consists of a set of two metal hollow rigid tubes that fit into each other.2 The inner tube rotates within the outer tube, is driven mechanically by an electrically powered control unit, and is controlled by a foot pedal that activates the rotation and regulates the direction of rotation of the inner tube. The control unit is connected to a handheld motor drive unit in which the morcellator is inserted. Both tubes have a window-opening at the end with cutting edges. By means of a vacuum source connected to the inner tube, the tissue is sucked into the window-opening, cut and ‘shaved’ as the inner tube is rotated.2 The system uses no electrocoagulation, and there is no lateral thermal or electrical energy spread. Haemostasis occurs by spontaneous myometrial contraction. The removed tissue is discharged through the device, is collected in a tissue-trap, and is available for pathology analysis. As only one introduction is needed, the number of perforations is extremely low. The 4.0-mm morcellator is introduced in the uterine cavity through a straight-forward working-channel of a continuous flow 8–9 mm rigid hysteroscope. After dilatation of the internal orifice of the uterine cervix, atraumatic insertion is accomplished with the use of an obturator in the outer sheath of the hysteroscope. Saline solution is used for distension and irrigation. Van Dongen et al.3 conducted a randomised-controlled trial (RCT) to compare conventional resectoscopy and hysteroscopic morcellation among residents in training. The mean operating time for resectosocpy and morcellation was 17.0 (95% confidence interval [95% CI] 14.1 to 17.9, standard deviation (SD) 8.4) and 10.6 (95% CI 7.3 to 14.0, SD 9.5) mins, respectively (P ¼ 0.008). Subjective surgeon and trainer scores for convenience of technique on a visual analogue scale were in favour of the morcellator. A new development in hysteroscopic morcellation is the recent availability of a smaller outer diameter TRUCLEARÔ system, with a 2.9-mm cutting-blade and a 5.0-mm hysteroscope for office or ambulatory use with no or local anaesthesia. Polyps, small myomas, and retained products of pregnancy can be removed in that way. A new morcellator system MyoSureÒ was recently introduced by Hologic (Bedford MA, USA). A recent patent infringement US jury-verdict could jeopardise its future availability. Another company that recently introduced an alternative device is Storz (Tuttlingen, Germany).
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Distension and irrigation Carbon dioxide (CO2) is rapidly absorbed and easily cleared from the body by respiration. The gas easily flows through narrow channels in small-diameter scopes that can be used for office-based diagnostic hysteroscopy. This method, however, offers no way to clear blood from the scope. With CO2, a hysteroscopic insufflator is required to regulate flow and limit maximal intrauterine pressure. The advantage of fluid over gas is the symmetric distention of the uterus with fluid and its effective ability to flush blood, mucus, bubbles, and small tissue fragments out of the visual field. A pressure of 60–80 mm Hg is usually adequate for uterine distention with low viscosity fluids like saline. Various delivery systems are designed to suit the media used for uterine distention and to accurately record volumes of inflow and outflow. This recording is important because fluid can leave the uterus by means of a fluid outflow channel, a mechanical morcellator, cervical or tubal leakage, or intravasation. Hanging, gravity-fed containers to deliver fluid can be raised or compressed with a cuff; however, these can be unreliable in estimating intrauterine pressures. Pumps are available to monitor pressure and volume for liquid media. Media then usually flow into the uterine cavity through an inner sheath around the hysteroscope. A perforated outer sheath is used for collection or outflow of media. This design creates laminar flow, which keeps the visual field clear. Normal saline and lactated Ringer solution are isotonic, conductive, low-viscosity fluids, which can be used for diagnostic hysteroscopy and for mechanical and bipolar operative procedures. The hypotonic, non-conductive, low-viscosity fluids mannitol (5%), sorbitol (3–5%), and glycine (1.5%), should be used only with monopolar operative procedures. Absorption of large volumes of electrolyte-free, low-viscosity fluid may result in volume overload with water intoxication, pulmonary oedema, hyponatraemia, hypo-osmolarity, and cerebral oedema, but these are extremely rare in office procedures. Nausea and malaise are the earliest findings, and may be seen when the plasma sodium concentration falls to 5 mmol/l (this relates to an intravasation of 500 ml of electrolyte-free fluids). This may be followed by headache, lethargy, and obtundation, and eventually seizures, coma and respiratory arrest if the plasma sodium concentration falls between 10 and 15 mmol/l. New developments are the availability of newer fluid-management systems that are more reliable and precise in measuring in- and outflow fluids, and therefore improve patient safety. Furthermore, most improvements result in better ergonomy and, therefore, systems become less inconvenient for hospital staff. Virtual hysteroscopy During the past decade, transvaginal ultrasonography of the uterus has become a routine procedure in the diagnostic work-up of several gynaecological problems. A normal sonographic finding has been shown to be accurate for the exclusion of clinically significant intra-cavitary abnormalities.4 Furthermore, this normal sonographic finding is well reproduced in the hands of different examiners.5 In the case of abnormal or inconclusive sonographic findings, however, diagnostic accuracy and reproducibility decline. To improve the image in these cases, sonographic examination using artificial uterine cavity distension was first described at our department.6 Saline infusion sonohysterography (SIS) has been extensively described.7–9 It is accepted that SIS improves the diagnostic accuracy of transvaginal ultrasonography in cases of abnormal or inconclusive findings, and that SIS is an effective early diagnostic step in the evaluation of women with pre- and postmenopausal abnormal uterine bleeding. The only contraindications are pregnancy and pelvic infection. Although the visualisation of the uterine cavity and its linings improves significantly, women experience discomfort resulting from either fluid leakage, while using a catheter without a balloon, or pain with the use of a balloon catheter. In trying to overcome these disadvantages, and to create a more stable filling of the uterine cavity, we modified the technique of SIS by instilling gel instead of flushing or infusing saline. This new technique and first experiences of gel instillation sonohysterography (GIS) have been described.10 Three- and four-dimensional ultrasound images can only be achieved when stable and adequate distension of the uterine cavity is achieved. This can only be achieved by the use of gel. We use the term ‘virtual hysteroscopy’ for such type of imaging. Further improvement of ultrasound technology and computer
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processing will create images revealing diagnostic information that is equal to diagnostic hysteroscopy with comparable or less pain, inconvenience for the woman, or both. The latest development in this field is the method to change the gel during dilution into a stable foam that is fluid enough to pass patent tubes and can be observed as a white echodense contrast during transvaginal ultrasonography in cases of a fertility work-up (hysterosalpingo-foam sonography [HyFoSy]).11
Methods and procedures Preoperative preparation and basic introduction of the hysteroscope The woman is placed in the lithotomy position; skin, intravaginal or intracervical antiseptical measures are not required. Without the need of a speculum and a tenaculum, the hysteroscope can be inserted vaginoscopically into the cervix. The outflow stopcock of the sheath should always be open during insertion to prevent a sudden increase of intrauterine pressure, which is painful in most cases. The hysteroscope is put through the internal cervical orifice under direct endoscopic vision. Ideally, this is carried out with no, or minimal, cervical dilatation, but a tenaculum may be required. Cooper et al.12 examined the effect of a vaginoscopic approach to outpatient hysteroscopy on the patients’ experience of pain, compared with a traditional approach using a vaginal speculum and tenaculum in a metaanalysis of six RCTs (n ¼ 1321). They found that vaginoscopic approach to hysteroscopy was less painful than using the traditional technique (standardised mean difference (SMD) 0.44, 95% CI from 0.65 to 0.22). No significant difference was found in the number of failed procedures between groups. One should be aware that the angle of view of most hysteroscopes is 12–30 fore-oblique; this means that the deepest part of the front-lens of the hysteroscope is normally located at 6 o’clock, and this tip should therefore be located in the centre of the internal orifice during its passage. Although a video camera and monitor is not requisite, it is strongly recommended for the benefit of the surgeon and it is a useful teaching aid. Many women also like to observe the images during the procedure. Ogden et al.13 showed that viewing the screen had no effect on several measures of pain perception, mood, illness cognitions or communication. Women who did not see the screen were more optimistic about the effectiveness of their treatment. Studies examining the use of pharmaceutical (e.g. prostaglandins and antiprogestogens) and mechanical (e.g. osmotic dilators) dilatation of the cervix before hysteroscopy have produced conflicting results on their effect on cervical dilatation and trauma during the procedure. A recent meta-analysis14 of six RCTs examined women undergoing outpatient hysteroscopy. The intervention was the use of cervical preparation compared with a control or placebo. The outcome was pain assessment. No evidence was found to recommend the routine administration of mifepristone or misoprostol to women before outpatient hysteroscopy.14 Cervical priming with vaginal prostaglandins may be considered in postmenopausal women if using hysteroscopic systems greater than 5 mm in diameter. Hysteroscopy is increasingly performed as an outpatient procedure. The primary reason for failure is pain. No consensus exists on the routine use of analgesia during hysteroscopy. In a Cochrane review,15 24 RCTs involving 3155 participants investigated pharmacological interventions for pain relief during hysteroscopy. Meta-analysis (nine RCTs, 1296 participants) revealed a significant reduction in the mean pain score for the use of local anaesthetics during the procedure compared with placebo (SMD 0.45, 95% CI 0.73 to 0.17). Meta-analysis (four RCTs, 454 participants) showed a significant reduction in the mean pain score for the use of local anaesthetics within 30 mins after the procedure compared with placebo (SMD 0.51, 95% CI 0.81 to 0.21). No significant reduction was found in the mean pain score more than 30 mins after the procedure. No significant reduction was reported in the mean pain score with the use of non-steroidal anti-inflammatory drugs or opioid analgesics compared with placebo during, within, or more than 30 mins after the procedure. No significant difference was found between the number of incidents of failure to complete the procedure owing to cervical stenosis between the intervention and control groups (OR 1.31, 95% CI 0.66 to 2.59; six RCTs, 805 participants). Significantly fewer incidents of failure to complete the procedure were reported in the intervention group than in the control group owing to pain (OR 0.29, 95% CI 0.12 to 0.69; two studies, 330
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participants). Meta-analysis showed no significant difference in adverse effects between the intervention and placebo groups. Another systematic review and meta-analysis of 20 RCTs (2851 participants)16 showed that paracervical local anaesthetic injection is the best method of pain control for women undergoing hysteroscopy as outpatients, whereas transcervical and topical application did not show a statistical difference compared with placebo. A vasovagal syncope is usually, but not always, associated with a prodrome of dizziness, nausea, pallor or diaphoresis. Once the procedure has been completed, assumption of the supine position with legs raised or Trendelenburg position at the onset of such symptoms can be helpful. Some women may require atropine.
Operative procedures In this particular field of hysteroscopy, no specific recent new developments have taken place other than mechanical morcellation. Most procedures can be carried out as day surgery. One of the most important factors in carrying out operative hysteroscopy is maintenance of a clear operative field at the lowest intrauterine pressure. This can only be accomplished by the use of a sheath that provides continuous laminar flow of media. Whether the outflow tubing is connected to a vacuum-collecting system, or whether the outflow is passive, is a matter of taste. An accurate assessment of the fluid deficit and lost media in the drapes, towels, or on the operating room floor, ideally by a fluid management system, is mandatory during extensive operative procedures, such as resectoscopy. During diagnostic or minor operative procedures, fluid measurements are not that important, because the risk of intravasation is low during procedures that take only minutes to perform. The uterus is a vascular organ, and its vascularity may be enhanced by uterine myomas or other pathology. Intraoperative bleeding, however, is generally not a significant problem because a rapid liquid flow will clean the image and, after the procedure, uterine contractions will diminish bleeding rapidly. The risk of infection after operative hysteroscopy is low, thus prophylactic antibiotics are not routinely administered during operative procedures. The only RCT17 to study the effect of prophylactic antibiotics on the incidence of bacteraemia after hysteroscopic surgery showed no convincing evidence that antibiotics are of value. Because of its relative simple use and safety, second-generation endometrial ablation techniques have almost completely replaced classical hysteroscopical endometrial resection. Although hysteroscopic polypectomy seems to be effective in the treatment of heavy menstrual bleeding, this has not yet been proven in RCTs,18 and may never be proven because of the lack of participant recruitment. An example of such a failed study was published in 2009.19 If, during hysteroscopy, an endometrial polyp was diagnosed, patients were asked to participate in this trial; after securing informed consent, they were allocated to immediate removal of the polyp or expectant management. This trial suffered from lack of recruitment related to doctors seeking informed consent and patients’ unwillingness to participate in this trial. In other words, it seems that patients want pathology removed even without complaints. Another RCT on subfertility, showed an effect of polypectomy on chances of pregnancy in women scheduled for intrauterine insemination.20 Although international consensus exists about the need for hysteroscopic removal of submucous myomas in cases of heavy menstrual bleeding or subfertility, no RCTs have been conducted to date. Intrauterine adhesions (IUA) are rare and almost always preceded by pregnancy-related intrauterine procedures, such as miscarriage curettage or a puerperal curettage for placental remnants. Intrauterine adhesions never occur spontaneously. In cases of hypomenorrhea or amenorrhea, hysteroscopic treatment is necessary if the woman is wanting to become pregnant. No RCTs have been published on IUA or Asherman’s disease, so the different treatment modalities are based on individual experience. As the condition is so rare, looking for primary prevention measures seems irrational, as the number needed to treat will probably always be too high. The search for adequate measures to prevent recurrent adhesions (secondary prevention), however, seem logical, and trials, preferably randomised, are urgently needed.
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A septated uterus is often associated with recurrent miscarriages or early pregnancy loss. Implantation is thought to be compromised by an abnormal vascularisation of the endometrium covering the septum. Hysteroscopic metroplasty is advised, but this has never been evaluated properly. A national RCT is currently ongoing in The Netherlands (The Randomised Uterine Septum transsection Trial: TRUST).21 Woman who have experienced recurrent miscarriages (minimal two) are asked to participate. The two arms of the trial aim to compare hysteroscopic transsection of the septum immediately or transsection after the next pregnancy. The primary outcome measure is the course of the next pregnancy. According to the Dutch National Guidelines, metroplasty is not advised until TRUST Trial has been completed and evaluated. In two RCTs, the effect of hysteroscopic procedures before embryo transfer (ET) as part of IVF, ICSI, or both, was studied. In one study, 421 participants with two or more failed embryo transfers were randomised to one group who had undergone a previous hysteroscopy and one group who had not before the next ET.22 A total of 154 women had normal cavities and 56 had operative hysteroscopies for small pathologies. In the group without hysteroscopies, 21.6% conceived; in the group with hysteroscopy, 32.5% conceived; and in the group with operative hysteroscopy, 30.5% conceived (P ¼ 0.044). In a similar study with 520 participants, these figures were 26.2%, 44.4% and 39.6%, respectively (P < 0.05).23 As a possible explanation for these differences is thought of an easier cervical passage and therefore more efficacious ET after hysteroscopy or favourable immunological changes in the endometrium caused by the (minimal) trauma after the hysteroscopy. The ongoing Dutch INSIGHT RCT is also assessing the effect of hysteroscopy before ET.24 Postoperative care The woman may immediately resume normal activities if sedatives have not been administered, otherwise she should be driven home and refrain from strenuous activities and those requiring mental alertness. She should contact the surgeon if she develops fever, foul discharge, heavy bleeding, or persistent pain. Later on, imaging studies can be used to determine whether a particular procedure was successful (e.g. ultrasound, control hysteroscopy, or both). The appropriate timing for postoperative evaluation should be individualised, and is based upon the recurrence of symptoms, difficulty of the procedure, and needs of the patient. No RCTs have supported any specific postoperative measures. Conclusion New developments in instrumentation and techniques changed hysteroscopy into a diagnostic and therapeutic tool that can and should be used in every gynaecological practice. Especially the further improvement of instruments for office hysteroscopy changed the field of female sterilization and intrauterine surgery. The introduction of hysteroscopic morcellation opens the option of hysteroscopic surgery for the majority of patients without the need for extensive training and experience for the gynaecologists. The increasing number of RCT’s in this field are helpful in improving the quality of clinical performance of hysteroscopy and are increasing the chances of a favourable outcome for patients. Practice points Reducing the outer diameter of hysteroscopes have made it possible to replace procedures from the operating room to the office. Hydrosalpinges, in cases of IVF or ICSI, can effectively be blocked hysteroscopically. Hysteroscopic morcellation seems to be easier to learn and master than resectoscopy. Improvements of ultrasound technology and computer processing create images that increasingly resemble diagnostic hysteroscopy (virtual hysteroscopy). The vaginoscopic approach is tolerated better than the traditional approach in office hysteroscopy.
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Research agenda Measures for the secondary prevention of intrauterine adhesions should be investigated prospectively and randomised. The effect of hysteroscopic metroplasty on recurrent miscarriage and infertility should be investigated prospectively and randomised. The effect of hysteroscopy before embryo transfer on implantation rate should be investigated further prospectively and randomised.
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