OBJECTIVE: To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. METHODS: Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. RESULTS:From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event. CONCLUSION: Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. FUNDING SOURCE: Boston Scientific Corporation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02277925.
RCT Entities:
OBJECTIVE: To compare mesh and permanent suture exposure rates in the first year after minimally invasive total hysterectomy and sacrocolpopexy with a light-weight polypropylene mesh using permanent or delayed absorbable sutures. METHODS: Across five centers in the United States, women were randomized to permanent or delayed absorbable suture for vaginal attachment of a Y-mesh during hysterectomy and sacrocolpopexy for stage II prolapse and worse. The primary outcome was mesh or permanent suture exposure in the first year after surgery. The secondary outcome was to compare a composite measure for success defined as leading edge of prolapse not beyond the hymen and apex not descended more than one third vaginal length, and no subjective bulge and no prolapse retreatment. Patients completed a pelvic examination including the pelvic organ prolapse quantification system and questionnaires at baseline, 6 weeks and 1 year postsurgery. A sample size of 80 per group was planned to compare the rate of mesh or permanent suture exposure in the permanent compared with delayed absorbable groups. RESULTS: From April 2015 to May 2019, 204 patients (n=102 permanent; n=102 delayed absorbable) were randomized. One hundred ninety-eight women had follow-up data, with 182 (93%) completing 1-year follow-up: 95 of 99 (96%) permanent, 87 of 101 (86%) delayed absorbable. The total rate of mesh or permanent suture exposure was 12 of 198 (6.1%): 5.1% for permanent compared with 7.0% for delayed absorbable (risk ratio 0.73, 95% CI 0.24-2.22). The majority (9/12) were asymptomatic. Composite success was 93% for permanent compared with 95% for delayed absorbable suture, P=.43). Six (3.0%) women had a serious adverse event. CONCLUSION: Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. FUNDING SOURCE: Boston Scientific Corporation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT02277925.
Authors: Deepanjana Das; Allison Carroll; Margaret Mueller; Kimberly Kenton; Christina Lewicky-Gaupp; Sarah Collins; Julia Geynisman-Tan; C Emi Bretschneider Journal: Int Urogynecol J Date: 2022-06-06 Impact factor: 1.932
Authors: Katherine L Woodburn; Amr Sherif El Haraki; Andrew I Sokol; Robert E Gutman; Catherine A Matthews Journal: Int Urogynecol J Date: 2022-02-14 Impact factor: 1.932
Authors: C Emi Bretschneider; Kimberly Kenton; Elizabeth J Geller; Jennifer M Wu; Catherine A Matthews Journal: Int Urogynecol J Date: 2020-08-26 Impact factor: 2.894