Permanent Versus Delayed-Absorbable Monofilament Suture (E-PACT)

Wake Forest University (WFU)

Status: Completed

Conditions: Sacrocolpopexy; Hysterectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04506177

IRB00036663

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who have participated in the PACT Study Trial (Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy: A Randomized Clinical Trial)

Exclusion criteria

• Patient is not willing to sign consent
• Patient does not want to fill-out questionnaires

Trial design

200 participants in 2 patient groups

Permanent Sutures

Description:

Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using permanent (polytetrafluoroethylene, Gore-Tex) suture for vaginal mesh attachment

Delayed Absorbable Monofilament Sutures

Description:

Women who previously received (in the PACT Study Trial) minimally-invasive total hysterectomy and sacrocolpopexy (SCP) with a light-weight polypropylene mesh (Upsylon™ y-mesh) using delayed absorbable monofilament (polydioxanone, PDS) suture for vaginal mesh attachment