Clinical trial NCT04506177: Permanent Versus Delayed-Absorbable Monofilament Suture
Official title: E-PACT: Extension Trial of Permanent Versus Delayed-absorbable Monofilament Suture for Vaginal Graft Attachment During Minimally-invasive Total Hysterectomy and Sacrocolpopexy
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hysterectomy
Sacrocolpopexy
Keywords: Pelvic Organ Prolapse
Vaginal mesh
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
First posted: 2020-08-10
Enrollment: 200
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Study Patients who have participated in the PACT Study Trial at one of the following Research Sites:

1. Wake Forest University, Winston-Salem (22 subject participants)
2. University of North Carolina, Chapel Hill
3. Northwestern Medical Center, Chicago
4. Augusta University, Augusta
5. Atrium Health, Charlotte

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vaginal Mesh or Suture Exposure
timeFrame: Post Procedure Evaluation at Minimum 2 years
measure: Vaginal Mesh or Suture Exposure
timeFrame: Post Procedure Evaluation at 3 years
Secondary outcomes:
measure: Anatomic success
timeFrame: Post Procedure Evaluation at Minimum 2 years and 3 years
measure: Subjective success
timeFrame: Post Procedure Evaluation at Minimum 2 years and 3 years
measure: Assessment for re-intervention or re-surgery for recurrence of persistence of POP
timeFrame: Post Procedure Evaluation at Minimum 2 years and 3 years
Other outcomes:
Locations:
city: Augusta
country: United States
facility: Augusta University
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Charlotte
country: United States
facility: Atrium Health
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Health Sciences
state: North Carolina
Study officials:
affiliation: Wake Forest Health Sciences
name: Catherine A Matthews, MD
role: PRINCIPAL_INVESTIGATOR
References: