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

Abstract

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 396.1 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 0.0002). 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 mor...

Success rate and patient satisfaction with the Essure™ sterilisation in an outpatient setting: a prospective study of 857 women

“…A high insertion success rate appears to be related to the hysteroscopist's experience, good technique and with the use of oral contraceptives and NSAIDs prior to the procedure. Essure tubal sterilisation is a favourable replacement for laparoscopic tubal occlusion 8 as it is less invasive, can be performed without hospital admission and has a low rate of failure and complications. The insertion is quick and well tolerated, and it permits a rapid return to normal activity producing a very high degree of patient satisfaction.…”

Contraception in women over 40 years of age

“…81 Hysteroscopic sterilization is less invasive than traditional laparoscopic techniques, presumably leading to a lower risk of serious complications. 82 Hysteroscopic tubal occlusion is advantageous for many older women who may not be good candidates for laparoscopic tubal sterilization because of intra-abdominal adhesions, medical comorbidities or obesity. 82 …”

“…82 Hysteroscopic tubal occlusion is advantageous for many older women who may not be good candidates for laparoscopic tubal sterilization because of intra-abdominal adhesions, medical comorbidities or obesity. 82 …”

The effect of menstrual phase and hormonal contraception on successful bilateral placement of the Essure micro-insert tubal coil

“…As more physicians adopt the Essure method for sterilization, they continue to look for techniques to improve the rate of successful bilateral coil placement on the first attempt. The reported bilateral placement rate ranges from 81% [1] to 98% [2]. It has been suggested that the procedure be completed in the follicular phase to improve visualization of the tubal ostia, and thus the successful placement of the coils [3][4][5].…”