Complications after laparoscopic sacrocolpopexy
Research type
Research Study
Full title
A cross sectional study of mesh related complications after laparoscopic sacrocolpopexy
IRAS ID
317105
Contact name
Matthew Izett-Kay
Contact email
Sponsor organisation
Oxford University Hospitals Foundation Trust
Duration of Study in the UK
1 years, 0 months, 0 days
Research summary
Research Summary:
Vaginal vault prolapse (the top of the vagina bulging down) is a common condition that is often associated with problems with the bladder, bowel and/or sex. It can affect Quality of Life (QoL). Laparoscopic sacrocolpopexy (LSC) is a keyhole procedure performed to treat vaginal vault prolapse. Research has shown LSC to be efficacious and safe; it is approved by the National Institute for Health and Care Excellence (NICE) in the United Kingdom (UK). LSC involves suspending the vagina to the base of the spine using a polypropylene mesh. The mesh used is placed into the abdomen in a similar fashion to hernia repair, the safety of which is well established. This is in contrast to transvaginal mesh for prolapse which has been largely abandoned in the UK due to significant complications and which no longer is supported within NICE guidance for routine clinical practice. Despite increasing scrutiny of mesh use in gynaecological surgery, there are few published studies designed to ascertain the incidence and nature of complications associated with mesh used during LSC. It is therefore important that safety, particularly with reference to mesh, is well understood.
In this study, patient notes will be accessed to identify women who have undergone LSH at the study centre. A comprehensive questionnaire will be used to collect data by post and telephone. Those women who have experienced complications will be asked for further details and for access to their clinical information regarding the mesh complication. It will allow calculation of the incidence and nature of patient reported mesh related complications following LSC.Summary of Results:
The primary outcome was patient-reported mesh complication requiring reoperation. Secondary outcomes included use of pain services, Patient Global Impression of Improvement (PGI-I) scores and reoperation for prolapse or incontinence.
There was a 58% (n = 334) completion rate from 574 eligible women identified. The median follow-up was 116 months (range 11–221). The rate of reoperation for a mesh-related AE was 1.5% (n = 5) and 3% (n = 10) were under the care of a pain specialist due to mesh-related pain. When asked how their prolapse symptoms were compared to pre-LSC, 5.7% reported them as ‘very much worse’ or ‘much worse’, compared to 70.4% who rated their symptoms ‘very much better’ or ‘much better’.
The operative rate for recurrent prolapse was 12% (n = 41) and for stress incontinence 7% (n = 23).REC name
West Midlands - Black Country Research Ethics Committee
REC reference
22/WM/0267
Date of REC Opinion
15 Mar 2023
REC opinion
Further Information Favourable Opinion