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Permanent Versus Delayed-Absorbable Monofilament Suture — E-PACT  

Hysterectomy Clinical Trial

Official title:
E-PACT: Extension Trial of Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy

Clinical Trial Summary

This is an extension study of a prospective, multicenter, randomized, single-blind trial whose purpose is to compare mesh-related complications and effectiveness of pelvic organ prolapse (POP) repair in women undergoing minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) versus delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment through at least 3 years after surgery.

Clinical Trial Description

This is an extension study of a randomized controlled trial that will be conducted at the same 5 clinical sites as the primary study - All subjects who participated in the original randomization and did not withdraw from the study are eligible for the extension study including those with a history of secondary treatment following PACT RCT study participation. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04506177
Study type Observational
Source Wake Forest University Health Sciences
Contact
Status Completed
Phase
Start date July 1, 2020
Completion date April 5, 2023
View Details
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