Permanent Compared With Absorbable Suture for Vaginal Mesh Fixation During Total Hysterectomy and Sacrocolpopexy: A Randomized Controlled Trial.
Aged
Female
Humans
Hysterectomy
/ methods
Laparoscopy
/ methods
Middle Aged
Pelvic Organ Prolapse
/ surgery
Polydioxanone
/ therapeutic use
Polytetrafluoroethylene
/ therapeutic use
Robotic Surgical Procedures
/ methods
Surgical Mesh
Suture Techniques
/ instrumentation
Sutures
Treatment Outcome
Vagina
/ surgery
Journal
Obstetrics and gynecology
ISSN: 1873-233X
Titre abrégé: Obstet Gynecol
Pays: United States
ID NLM: 0401101
Informations de publication
Date de publication:
08 2020
08 2020
Historique:
pubmed:
11
7
2020
medline:
13
11
2020
entrez:
11
7
2020
Statut:
ppublish
Résumé
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. 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. 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. Suture type used for vaginal graft attachment did not influence mesh or permanent suture exposure rates. Boston Scientific Corporation. ClinicalTrials.gov, NCT02277925.
Identifiants
pubmed: 32649494
doi: 10.1097/AOG.0000000000003884
pii: 00006250-202008000-00021
doi:
Substances chimiques
Polydioxanone
31621-87-1
Polytetrafluoroethylene
9002-84-0
Banques de données
ClinicalTrials.gov
['NCT02277925']
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
355-364Références
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