Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation

Transcription

1 BJOG: an International Journal of Obstetrics and Gynaecology November 2005, Vol. 112, pp DOI: /j x Female sterilisation: a cohort controlled comparative study of ESSURE versus laparoscopic sterilisation Sean Duffy, a Fiona Marsh, a Lynne Rogerson, a Heather Hudson, a Kevin Cooper, b Stuart Jack, b David Hunter, c Graham Philips c Objective To compare patient satisfaction, discomfort, procedure time, success rate and adverse events of hysteroscopic (ESSURE, Conceptus Inc, San Carlos, USA) versus laparoscopic sterilisation. Design Cohort controlled comparative study. Setting The day surgery and outpatient unit of three large UK hospitals. Population Eighty-nine women requesting sterilisation were enrolled into the study. Methods A 2:1 ratio of ESSURE placement to laparoscopic sterilisation was undertaken. Laparoscopic sterilisation was carried out under general anaesthesia in the day surgery unit whereas all ESSURE procedures were carried out in a dedicated outpatient facility. All patients completed a self-assessment diary on days 7 and 90 post-operatively. Patient satisfaction, tolerance and discomfort were measured using an ordinal Likert style scale. Data were analysed using the m 2 test for statistical significance. Main outcome measures The primary outcome measure is patient satisfaction with ESSURE versus laparoscopic sterilisation. This included satisfaction with the decision to proceed with the relevant sterilisation method, recovery from the procedure and overall satisfaction following either ESSURE or laparoscopic sterilisation. Secondary outcome measures include successful completion of procedure, procedure time, tolerance, patient discomfort and post-operative adverse events. Results All women who underwent laparoscopic sterilisation had the procedure successfully completed whereas the overall bilateral device placement rate for ESSURE was 81%. Patient satisfaction with their decision to undergo either ESSURE or laparoscopic sterilisation was high with 94% of the ESSURE group being very or somewhat satisfied at 90 days post-procedure versus 80% in the laparoscopic sterilisation group. At 90 days post-procedure 100% of women in the ESSURE group were very satisfied with their speed of recovery versus 80% in the laparoscopic sterilisation group. The procedure time (defined from the time of insertion of the hysteroscope or laparoscope to its removal) took significantly longer for ESSURE than laparoscopic sterilisation (mean ¼ 13.2 vs 9.7 minutes, P ¼ 0.045). However, the time required for insertion of a Verres needle and insufflation of the abdominal cavity is a necessary part of the laparoscopic sterilisation and had it been included would bring the procedures times more in line with each other. The mean time spent in hospital was significantly shorter for the ESSURE group than the laparoscopic group (188.7 vs minutes, P < 0.005). Eighty-two percent of women in the ESSURE group described their tolerance of the procedure between good and excellent compared with only 41% of the laparoscopic sterilisation group (P ¼ ). Only 31% of the ESSURE group reported moderate or severe pain following the procedure compared with 63% of the laparoscopic sterilisation group (P ¼ 0.08). Only 11% of patients had problems immediately post-operatively in the ESSURE group compared with 27% in the laparoscopy group. Finally, in the more medium term (three months post-operatively), patients still had an advantage in terms of post-procedure adverse events in the ESSURE group (21% vs 50%). Conclusions This study provides evidence that ESSURE can be performed in the majority of women and, when successful, is associated with a greater overall patient satisfaction rate than laparoscopic sterilisation. Women also spend less time in hospital, have better tolerance of the procedure and describe less severe postoperative pain. However, the devices cannot be bilaterally placed in all cases and some women do not tolerate the procedure awake. INTRODUCTION a St. James s University Hospital, Leeds, UK b Aberdeen Royal Infirmary, Foresterhill, Aberdeen, UK c James Cook University Hospital, Middlesbrough, UK Correspondence: F. Marsh, St James s University Hospital, Beckett Street, Leeds LS9 7TF, UK. D RCOG 2005 BJOG: an International Journal of Obstetrics and Gynaecology A total of 49,000 women per year in the UK choose to undergo permanent sterilisation as their chosen method of contraception. The proportion of women who make this choice has been remarkably consistent over the last 20 years. 1,2 The most common method of permanent female sterilisation in

2 this country is laparoscopic sterilisation often carried out as a day case procedure under general anaesthesia (GA). Laparoscopic sterilisation requires two abdominal wall skin incisions followed by the introduction of a laparoscopic trocar and cannula through these incisions. As well as the small risk associated with GA, laparoscopic sterilisation has specific complications associated with it, which can be serious. 3 The most common quoted risks are those related to perforation or damage to small and large bowel and damage to major abdominal wall vessels. 4 A new method of hysteroscopic sterilisation has been developed and investigated through phase 2 and phase 3 trials. The ESSURE micro-insert allows the placement of microcoils into the fallopian tubes hysteroscopically and can be successfully carried out in an outpatient setting. 5 Hysteroscopic placement of these micro-inserts does not normally require GA or an operating theatre facility. The ESSURE micro-insert incites a tissue response, which, in a correctly placed device, results in permanent sterilisation within three months of insertion. 6 To provide evidence that this new method of female sterilisation confers an advantage, in terms of patient satisfaction, over the traditional method of laparoscopic sterilisation a comparative study was proposed. The study is unusual in that it is comparing not only two different methods of sterilisation but is also investigating the environment in which the procedures are carried out (day case GA vs outpatient no anaesthesia). Although the pros and cons of outpatient versus day case procedures are inextricably linked to patient satisfaction with the procedure itself, one of the advantages of this study is that it measures and compares the entire experience, for the woman, of both sterilisation methods. METHODOLOGY A preliminary pilot study was undertaken to assess the feasibility of conducting this comparative study in a randomised fashion. 7 Because of the general lack of knowledge on this new technique and because anaesthesia is different (day case GA vs outpatient no anaesthesia), it was anticipated that patients perceptions and preferences might be very different between the two approaches for permanent sterilisation. This in turn could lead to difficulties in patient recruitment. This turned out to be the case during the pilot study with less than 8% of women approached willing to be randomised. 7 The majority of women expressed a preference for laparoscopic sterilisation, the most common reason being a desire to be asleep. The main reason women preferred hysteroscopic sterilisation was the quick recovery period. For this reason a cohort controlled comparative study design was employed. As much of the information about laparoscopic female sterilisation already exists, it was important that the weight of the cohorts was in favour of the newer ESSURE micro-insert technique. The investigators chose to undertake a 2:1 ratio of ESSURE placement to laparoscopic sterilisation. Ethics approval was obtained for patients to participate in this study. A total of 89 patients, from three centres, were enrolled in the study, of which 59 underwent an ESSURE microinsert procedure. Twenty-four patients underwent laparoscopic sterilisation. Six patients either failed on the screening visit or changed their mind about participation in the study. The patient tree for those entering and progressing through the study is set out in Fig. 1. The patients undergoing laparoscopic sterilisation all had the procedure carried out successfully. Laparoscopic female sterilisation was carried out in the standard format. Patients were admitted on the morning of surgery and underwent sterilisation under GA. Female sterilisation was achieved using the Filshie clip (Femcare, UK). All patients recovered sufficiently after the procedure to be discharged home on the day of surgery. All ESSURE procedures were carried out in a dedicated outpatient facility. Continuous flow hysteroscopy was employed using a 5.5-mm hysteroscope (Olympus, Key- Med, UK). ESSURE micro-insert hysteroscopic sterilisation involves the bilateral placement of a coiled micro-insert into the proximal section of the fallopian tube, under hysteroscopic visualisation. 5 The device then induces an inflammatory process, which leads to occlusion of the fallopian tubes. Seventy percent of the ESSURE placements were carried out without anaesthesia with 30% of patients undergoing some form of local anaesthesia prior to insertion of the hysteroscope. This usually took the form of intracervical lignocaine in a four-quadrant block. All women who underwent ESSURE were discharged homeonthesamedayastheprocedure. As part of this study design all patients completed a selfassessment diary and were contacted by the study team following discharge. The primary outcome, patient satisfaction, was judged by patients completing questionnaires on days 7 and 90. The patient diary recorded satisfaction with the sterilisation decision, speed of recovery after the procedure and overall satisfaction with the procedure chosen. Patients used a verbal rating scale as follows:. Very satisfied. Somewhat satisfied. Neither satisfied nor dissatisfied. Somewhat dissatisfied. Very dissatisfied ESSURE VERSUS LAPAROSCOPIC STERILISATION 1523 Secondary outcome measures include successful completion of procedure, procedure time, tolerance, patient discomfort and post-operative adverse events. Patient tolerance and discomfort were also measured using an ordinal Likert style scale and determined while

3 1524 S. DUFFY ET AL. Fig. 1. Patient tree of women entering study. patients were in the recovery room. All patients were required to rate their tolerance as follows:. Poor. Fair. Good. Very good. Excellent Women were then asked to describe the discomfort they experienced during the procedure. The following pain rating categories were used to record this information:. None. Mild. Moderate. Severe Adverse events (unintended injuries or complications as a result of the sterilisation) were recorded at the following time points:. Recovery room. Day of procedure. One week post-procedure. Three months post-procedure Data were analysed using the m 2 test for statistical significance. RESULTS The mean age for both techniques was similar (35.1 years for the ESSURE patients and 36.1 years for the laparoscopy patients). The median parity was also similar in both groups (2.3 for ESSURE patients and 2.4 for laparoscopy patients). Table 1. Bilateral placement rate for ESSURE device. Bilateral placement first attempt 76% (45/59) Unilateral placement first attempt 7% (4/59) Unilateral bilateral placement second attempt 67% (2/3) No placement first attempt 12% (7/59) No placement bilateral placement, second attempt 50% (1/2)

4 ESSURE VERSUS LAPAROSCOPIC STERILISATION 1525 Fig. 2. Patient satisfaction at 7 and 90 days post-operative with decision to undergo ESSURE or laparoscopic sterilisation. All patients who chose laparoscopic sterilisation had the procedure successfully completed. The overall bilateral placement rate for the ESSURE device was 81% (48/59). Table 1 provides information on the micro-insert placement attempts. The study protocol following unilateral or bilateral placement required that a hysterosalpingogram (HSG) be carried out after three months. In the case of unilateral placement, if the HSG showed tubal patency the investigator was allowed to re-attempt the placement procedure. Of the four patients who had a unilateral placement, three had tubal patency and all three had the second placement attempt. Two of the three were successful. Seven patients had failure of bilateral device placement on the first attempt and of these four women underwent a follow up HSG. Two of these patients had bilateral occlusion on HSG and were terminated from the study. The other two had second placement attempts, one of which was successful. Of the remaining three patients the investigators were unable to enter the uterine cavity with the hysteroscope. Two patients had a stenotic cervix and one patient experienced pain all resulting in abandoning of the procedure. These three patients did not wish any further follow up or re-attempts. Patient satisfaction with the ESSURE method (documented for those who had successful bilateral placement) of sterilisation and the decision to undergo ESSURE was high (Fig. 2). The trend was for an increase in satisfaction over time, culminating in a 94% rate of either very satisfied or somewhat satisfied among this study group. Even though six patients indicated they were very dissatisfied on day 7 this trend did not continue and they indicated that they were satisfied with all other aspects of the ESSURE procedure. The reasons for persistent dissatisfaction in two patients on day 90 were post-procedure pain and bleeding. Patient satisfaction with laparoscopic sterilisation was also high, up to a maximum of 80 81% either expressing very satisfied or somewhat satisfied on day 90. The difference in satisfaction rates between the two groups did not reach statistical significance. Satisfaction with speed of recovery following the procedures is summarised in Fig. 3. Satisfaction with speed of recovery was consistently higher from the outset with the ESSURE procedure and increasing over time to 100% on Fig. 3. Patient satisfaction at 7 and 90 days with speed of recovery following ESSURE or laparoscopic sterilisation.

5 1526 S. DUFFY ET AL. Fig. 4. Patient satisfaction at 7 and 90 days with their chosen sterilisation procedure following ESSURE or laparoscopic sterilisation. day 90. Satisfaction with speed of recovery was somewhat less in the laparoscopic group reaching 80% on day 90, although this did not reach statistical significance. Overall patient satisfaction with their own chosen method of sterilisation was also collated (Fig. 4). The main reason for not being satisfied on day 90 in the laparoscopy group was related to abdominal pain and bleeding. The ESSURE patients exhibited higher rates of satisfaction at the outset, which continued throughout the evaluation period. The procedure time (defined from the time of insertion of either hysteroscope or laparoscope to the time of its removal) differed between the two groups being significantly longer for the ESSURE group than the laparoscopic sterilisation group. The ESSURE micro-insert placement took, on average, approximately 13.2 [7.73] minutes (mean [SD]), whereas the Filshie clip placement took, on average, 9.7 [4.3] minutes (P ¼ 0.045). The time required for insertion of a Verres needle and insufflation of the abdominal cavity is a necessary part of the laparoscopic sterilisation and had it been included would bring the procedures times more in line with each other. Overall time spent in hospital was considerably different being almost twice as long for laparoscopic sterilisation, [141.1] minutes (mean [SD]) compared with [181.2] minutes for the ESSURE procedure (P < 0.005). Patient tolerance of the procedures was also recorded. The ESSURE procedure recorded 82% good excellent tolerance of the procedure compared with 41% in the laparoscopy group (P ¼ ). Patients who rated their pain as moderate or severe were categorised in Table 2. Laparoscopic sterilisation was associated with significantly more patients experiencing either moderate or severe pain in the recovery room. The proportion of reported adverse events are summarised in Table 3. In the recovery room six patients in each group experienced an adverse event. Two of the ESSURE patients experienced a vasovagal reaction, one patient had cervical bleeding, one had a suspected tubal perforation and two had post-operative pain. In the laparoscopy group one patient described nausea and vomiting, one had severe postoperative pain, three experienced a cervical tear and one had a uterine fundal perforation. The same adverse events reported in the recovery room were also reported as occurring on the day of the procedure. There were no additional adverse events beyond those reported in the recovery room. At one week post-procedure three ESSURE patients reported the following adverse events:. One patient reported pain, infection in perineum, prolonged bleeding, thrush and mood swings.. A second patient reported a headache.. The third patient reported vaginal spotting. The following adverse events were reported in the laparoscopic sterilisation:. One patient had inflammation of the umbilicus and also retention of urine.. One patient had backache and cramp.. One patient suffered from constipation haemorrhoids and wound infection.. One patient had headaches, dizziness and abdominal pain. Table 2. Patient discomfort during and after sterilisation. Women who categorised pain as moderate or severe during the procedure Women who categorised pain as moderate or severe after the procedure (i.e. in recovery room) ESSURE sterilisation (n ¼ 55) Laparoscopic sterilisation (n ¼ 22) 65% N/A (under general anaesthetic) N/A 31% 63% P

6 Table 3. Adverse events following sterilisation. Point of occurrence At three months, six patients in each group described additional symptoms. In the ESSURE group one patient described mild pain in the region of the left side of the abdomen. One patient complained of bilateral pelvic pain. Two patients reported right-sided abdominal pain. One patient reported musculoskeletal pain in the right lower quadrant and one patient had possible salpingitis. In the laparoscopy group one patient reported lower abdominal pain. One patient reported inflammation of the umbilicus. Two patients reported definitive wound infection. The fifth patient reported a wound that was weeping. The sixth patient reported headaches and reflux oesophagitis. In addition to these adverse events one ESSURE patient became pregnant during the study. At the end of the device placement a review X-ray showed that the device on the left-hand side was suspiciously sited. The patient failed to attend on two occasions for HSG. She therefore had not complied with the protocol. It is likely that she had an immediate expulsion post-placement of the left-sided device. DISCUSSION ESSURE (%) Laparoscopy (%) Recovery room 11 (n ¼ 55) 27 (n ¼ 22) N/S Day of procedure 11 (n ¼ 55) 27 (n ¼ 22) N/S One week post-procedure 5 (n ¼ 55) 18 (n ¼ 22) N/S Three months post-procedure 21 (n ¼ 29) 50 (n ¼ 12) N/S This is the first comparative study of a new hysteroscopic method of sterilisation against a laparoscopic method of sterilisation. The authors investigated the feasibility of undertaking a randomised controlled trial of hysteroscopic versus laparoscopic sterilisation in order to minimise bias. However, only 8% of women were in equipoise when questioned about their preference for either laparoscopic sterilisation under general anaesthetic or hysteroscopic sterilisation awake in the outpatient setting. Thus, had a randomised controlled trial been undertaken, recruitment would have been difficult and protracted and the participants within the trial would represent only a small percentage of women eligible for either laparoscopic or hysteroscopic sterilisation. Therefore, a cohort controlled comparative trial was chosen as the design of this study in order to have the opportunity of recruiting all patients who are suitable for either form of sterilisation but would not consent to be randomised. Although a power calculation was not undertaken the study was designed to recruit a 2:1 ratio of ESSURE placement to laparoscopic sterilisation. This method was chosen in order to gather the majority of information from the newer hysteroscopic sterilisation technique. This is a prospective longitudinal study that not only compares two P ESSURE VERSUS LAPAROSCOPIC STERILISATION 1527 methods of sterilisation but also compares an outpatient with a day case general anaesthetic-based procedure. Overall, the vast majority of patients expressed satisfaction with both types of techniques. There were differences, however, between the two groups and it is important to note that in the ESSURE group only those women who had successful bilateral placement responded (81% of those allocated to ESSURE) completed satisfaction questionnaires about this method of sterilisation (Fig. 1). This may potentially be biasing the satisfaction results in favour of ESSURE and should be considered when interpreting the results. In terms of satisfaction with the sterilisation decision there tended to be a higher level of satisfaction from the time of the procedure persisting through to 90 days with the ESSURE procedure. Overall, the reasons for dissatisfaction seemed to be similar in both (pain and bleeding). Similarly, in terms of speed of recovery, patients were more likely to be immediately satisfied following the ESSURE procedure compared with the laparoscopic procedure and this difference persisted up to 90 days. Overall patient satisfaction was reflected in the increased proportion of those in the ESSURE group expressing satisfaction within a week of the procedure compared with that of the laparoscopic group. The proportion of patients expressing good or excellent tolerance in the ESSURE group was significantly more in fact double that of the laparoscopic group. The failure of placement of the ESSURE device was slightly greater than had previously been reported from the earlier phase 2 and 3 studies. 8 The latter studies reported an 88 90% bilateral placement rate whereas this study reports an 81% bilateral placement rate. This is most likely due to the relative inexperience and learning curve of three of the four investigators who participated in this study. This still, however, translates to 8 out of 10 patients being able to undergo the procedure, thus avoiding a general anaesthetic and hospital stay. The procedure time for the hysteroscopic procedure represents a greater proportion of the time the patient was in hospital compared with the procedure time for the laparoscopic sterilisation, which, as a proportion, was small. The difference is that women undergoing laparoscopic sterilisation needed considerable support from the other services within the hospital, such as anaesthetic, theatre and recovery services. This will obviously have an implication to service costs, which are likely to be far greater in the laparoscopic group. Hysteroscopic sterilisation offers obvious advantages to patients as the time required to be in hospital is significantly less than for laparoscopic sterilisation. This shorter time in hospital did not in any way detract from overall satisfaction. Patient tolerance for the hysteroscopic procedure was high. This was also reflected in the proportion of patients post-procedure that had average or severe pain. In the ESSURE group half the number of patients were in this

7 1528 S. DUFFY ET AL. category compared with the laparoscopy group a finding that reached statistical significance. Further advantages of the hysteroscopic technique were seen when the adverse events were looked at in detail. Only 11% of patients had problems immediately post-operatively in the ESSURE group compared with 27% in the laparoscopy group. In addition, in the more medium term, patients still had an advantage in terms of post-procedure adverse events in the ESSURE group (21% vs 50%). It is interesting that the majority of patients who had problems in the laparoscopy group at three months were those who developed inflammation or infection from their surgical wounds (four out of six patients). Obviously the patient who became pregnant in the ESSURE group was a serious adverse event. However, at the end of the procedure it was recognised that the placement of the device was suboptimal, and within the protocol follow up by HSG was mandatory. The patient failed to comply with the follow up arrangements and became pregnant. When micro-insert placement is not ideal the most likely outcome is that it will be expelled spontaneously. This new method of hysteroscopic sterilisation will not suit every patient. There are some in which the device cannot be placed and some patients who do not tolerate the procedure. However, this only occurs in a minority of patients. CONCLUSION This study provides evidence that a hysteroscopic method of permanent female sterilisation can be performed in the majority of women and, when successful, is associated with a significantly higher satisfaction rate than that for the traditional method of laparoscopic female sterilisation. In addition, the hysteroscopic procedure is well tolerated; women spend significantly less time in hospital and experience less severe post-operative pain than with laparoscopic sterilisation. The ESSURE micro-insert therefore confers a number of advantages to women and this should facilitate the transfer of a traditional theatre-based procedure into an outpatient setting. References 1. Omnibus Survey. Office for National Statistics, Available: www. statistics.gov.uk. 2. NHS Hospital Data. Office for National Statistics, Available: 3. Escobedo LG, Peterson HB, Grubb GS, Franks AL. Case fatality notes for tubal sterilisation in US hospitals 1979 to Am J Obstet Gynecol 1989;160: Garry R. Towards evidence-based laparoscopic entry techniques: clinical problems and dilemmas. Gynaecol Endosc 1999;8: Rogerson L, Hudson H, Duffy S. UK Experience using the ESSURE micro-insert for hysteroscopic sterilisation. Rev Gynaecol Pract 2003; 3: Kerin JF, Carignan CS, Cher D. The safety and effectiveness of a new hysteroscopic method for permanent birth control: results of the first Essure (TM) pbc clinical study. Aust N Z J Obstet Gynaecol 2001; 41: (November). 7. Baxter N, Hudson H, Duffy S. Hysteroscopic sterilisation: a study of women s attitudes to a novel procedure. BJOG 2005;112(3): DOI: /j x. 8. Kerin J, et al. Hysteroscopic sterilisation using a micro-insert device: results of a multicentre phase II study. Hum Reprod 2003;18(6): (June). Accepted 11 May 2005