TY - JOUR
T1 - How common are complications following polypropylene mesh, biological xenograft and native tissue surgery for pelvic organ prolapse?
T2 - A secondary analysis from the PROSPECT trial
AU - Reid, F. M.
AU - Elders, A.
AU - Breeman, S.
AU - Freeman, R. M.
AU - Glazener, C. M.A.
AU - Hemming, C.
AU - Cooper, K. G.
AU - Smith, A. R.B.
AU - Hagen, S.
AU - Montgomery, I.
AU - Kilonzo, M.
AU - Boyers, D.
AU - McDonald, A.
AU - McPherson, G.
AU - MacLennan, G.
AU - Norrie, J.
AU - the PROSPECT study group
N1 - Funding
The project was funded by the National Institute for Health Research Health Technology Assessment Programme (Project Number 07/60/18). The Health Services Research Unit is funded by the Chief Scientist Office of the Scottish Government Health and Social Care Directorates.
Acknowledgements
The authors wish to thank the women who participated in the PROSPECT study. We also thank Margaret MacNeil for her secretarial support and data management, the programming team in CHaRT and the staff at the recruitment sites who facilitated the recruitment, treatment and follow up of study participants.
PY - 2021/12/1
Y1 - 2021/12/1
N2 - Objective: To report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs. Design: Secondary analysis of the PROSPECT randomised controlled trial and cohort study. Setting: Thirty-five UK hospitals. Population: A total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair. Methods: Event rates were calculated for all complications. Analysis was by treatment received. Main outcome measures: IUGA/ICS classification of complications and validated patient reported outcome measures. Results: At baseline, 8.4% of women had ‘generic’ pain/discomfort; at 2 years following surgery, there was an improvement in all four groups; however, 3.0% of women developed de novo extreme generic pain. At 24 months de novo vaginal tightness occurred in 1.6% of native tissue, 1.2% of biological xenograft, 0.3% of mesh inlay and 3.6% of mesh kit. Severe dyspareunia occurred in 4.8% of native tissue, 4.2% of biological xenograft, 3.4% of mesh inlay repairs and 13.0% of mesh kits. De novo severe dyspareunia occurred in 3.5% of native tissue, 3.5% of biological xenograft, 1.4% of mesh inlays and 4.8% of mesh kits. Complications requiring re-admission to hospital, unrelated to mesh, affected 1 in 24 women; the most common reasons for re-admission were vaginal adhesions, urinary retention, infection and constipation. Conclusions: This is the first study to address the complications of vaginal mesh used for prolapse surgery alongside data from both native tissue and biological xenograft. It demonstrates the complexity of assessing pain and that all types of prolapse surgery have low surgical morbidity and a low rate of severe complications. Tweetable abstract: A prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.
AB - Objective: To report complication rates following prolapse surgery using polypropylene mesh inlay, polypropylene mesh kit, biological collagen xenografts and native tissue repairs. Design: Secondary analysis of the PROSPECT randomised controlled trial and cohort study. Setting: Thirty-five UK hospitals. Population: A total of 2632 women undergoing anterior and/or posterior vaginal prolapse repair. Methods: Event rates were calculated for all complications. Analysis was by treatment received. Main outcome measures: IUGA/ICS classification of complications and validated patient reported outcome measures. Results: At baseline, 8.4% of women had ‘generic’ pain/discomfort; at 2 years following surgery, there was an improvement in all four groups; however, 3.0% of women developed de novo extreme generic pain. At 24 months de novo vaginal tightness occurred in 1.6% of native tissue, 1.2% of biological xenograft, 0.3% of mesh inlay and 3.6% of mesh kit. Severe dyspareunia occurred in 4.8% of native tissue, 4.2% of biological xenograft, 3.4% of mesh inlay repairs and 13.0% of mesh kits. De novo severe dyspareunia occurred in 3.5% of native tissue, 3.5% of biological xenograft, 1.4% of mesh inlays and 4.8% of mesh kits. Complications requiring re-admission to hospital, unrelated to mesh, affected 1 in 24 women; the most common reasons for re-admission were vaginal adhesions, urinary retention, infection and constipation. Conclusions: This is the first study to address the complications of vaginal mesh used for prolapse surgery alongside data from both native tissue and biological xenograft. It demonstrates the complexity of assessing pain and that all types of prolapse surgery have low surgical morbidity and a low rate of severe complications. Tweetable abstract: A prospective study of 2362 women undergoing vaginal mesh, xenograft or native tissue repair found low surgical morbidity and low rates of severe complications.
KW - Cumberlege report
KW - dyspareunia
KW - IUGA/ICS complications classification
KW - pain
KW - polypropylene mesh
KW - prolapse
KW - surgery
KW - surgical complications
UR - http://www.scopus.com/inward/record.url?scp=85116812093&partnerID=8YFLogxK
U2 - 10.1111/1471-0528.16897
DO - 10.1111/1471-0528.16897
M3 - Article
C2 - 34473896
AN - SCOPUS:85116812093
VL - 128
SP - 2180
EP - 2189
JO - BJOG-An International Journal of Obstetrics and Gynaecology
JF - BJOG-An International Journal of Obstetrics and Gynaecology
SN - 1470-0328
IS - 13
ER -