Complications after laparoscopic sacrohysteropexy
Research type
Research Study
Full title
Complications after laparoscopic sacrohysteropexy with a focus on mesh, a multi-centre retrospective cohort study.
IRAS ID
235195
Contact name
Arvind Vashisht
Contact email
Sponsor organisation
University College London
Clinicaltrials.gov Identifier
Z6364106/2017/11/98, UCL Data Protection Registration reference Number; 18/LO/0637, REC
Duration of Study in the UK
0 years, 6 months, 0 days
Research summary
This study has been developed to ascertain the incidence and nature of mesh related complications requiring surgery in women who have been treated for prolapse using key-hole prolapse surgery. Uterine (womb) prolapse is a common condition impacting bladder, bowel and sexual function as well as quality of life. Studies estimate 20% of women will undergo surgery for vaginal prolapse in their lifetime. The most commonly performed operation is a vaginal hysterectomy, however as many as 30% of women will require repeat surgery due to recurrence.
Laparoscopic (key-hole) sacrohysteropexy (LSH) is a relatively novel, womb sparing, minimally invasive procedure performed to treat such prolapse. The procedure utilises a synthetic mesh to suspend the womb and restore normal anatomical position of the womb within the pelvis. However, despite increasing concerns over the involvement of mesh in gynaecological surgery there are no published studies designed to ascertain the incidence and nature of complications associated with mesh used during LSH.
This study will utilise a questionnaire that has been developed with input from experts in field. It will be sent to all women who have undergone the ‘wrap round’ variant of LSH in enrolled centres. The questionnaire has been designed to ascertain the timing, nature and incidence of complications associated with the placement of mesh as part of the LSH procedure. It ascertain rates of re-operation and overall satisfaction with the procedure. It will be sent via post with patients able to fill in a secure online questionnaire, return a postal questionnaire or request a telephone questionnaire. Non-responders will receive one further postal questionnaire.REC name
London - City & East Research Ethics Committee
REC reference
18/LO/0637
Date of REC Opinion
11 May 2018
REC opinion
Further Information Favourable Opinion