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Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT)
- Source :
- 2020, ' Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery : randomised controlled trial (PROSPECT) ', BJOG: An International Journal of Obstetrics and Gynaecology . https://doi.org/10.1111/1471-0528.16197, Glazener, C, Freeman, R, Breeman, S & Reid, F 2020, ' Mesh inlay, mesh kit or native tissue repair for women having repeat anterior or posterior prolapse surgery: randomised controlled trial (PROSPECT) ', BJOG: an international journal of obstetrics and gynaecology . https://doi.org/10.1111/1471-0528.16197
- Publication Year :
- 2020
- Publisher :
- Wiley, 2020.
-
Abstract
- Objective To compare standard (native tissue) repair with synthetic mesh inlays or mesh kits. Design Randomised controlled trial. Setting Thirty-three UK hospitals. Population Women having surgery for recurrent prolapse. Methods Women recruited using remote randomisation. Main outcome measures Prolapse symptoms, condition-specific quality-of-life and serious adverse effects. Results A Mean Pelvic Organ Prolapse Symptom Score at 1 year was similar for each comparison (standard 6.6 versus mesh inlay 6.1, mean difference [MD] -0.41, 95% CI -2.92 to 2.11: standard 6.6 versus mesh kit 5.9, MD -1.21 , 95% CI -4.13 to 1.72) but the confidence intervals did not exclude a minimally important clinical difference. There was no evidence of difference in any other outcome measure at 1 or 2 years. Serious adverse events, excluding mesh exposure, were similar at 1 year (standard 7/55 [13%] versus mesh inlay 5/52 [10%], risk ratio [RR] 1.05 [0.66-1.68]: standard 3/25 [12%] versus mesh kit 3/46 [7%], RR 0.49 [0.11-2.16]). Cumulative mesh exposure rates over 2 years were 7/52 (13%) in the mesh inlay arm, of whom four women required surgical revision; and 4/46 in the mesh kit arm (9%), of whom two required surgical revision. Conclusions We did not find evidence of a difference in terms of prolapse symptoms from the use of mesh inlays or mesh kits in women undergoing repeat prolapse surgery. Although the sample size was too small to be conclusive, the results provide a substantive contribution to future meta-analysis. Tweetable abstract There is not enough evidence to support use of synthetic mesh inlay or mesh kits for repeat prolapse surgery.
- Subjects :
- medicine.medical_specialty
education.field_of_study
030219 obstetrics & reproductive medicine
Inlay
business.industry
Prolapse surgery
Population
Obstetrics and Gynecology
Confidence interval
law.invention
Surgery
03 medical and health sciences
0302 clinical medicine
Randomized controlled trial
law
Sample size determination
Relative risk
Prolapse
Medicine
business
education
Adverse effect
Subjects
Details
- ISSN :
- 14710528 and 14700328
- Volume :
- 127
- Database :
- OpenAIRE
- Journal :
- BJOG: An International Journal of Obstetrics & Gynaecology
- Accession number :
- edsair.doi.dedup.....857e85bb07563af6bb138cc5c1b4ecda