Permanent Versus Delayed-Absorbable Monofilament Suture

Completed

• Conditions: Hysterectomy; Sacrocolpopexy

• Registration Number: NCT04506177
• Lead Sponsor: Wake Forest University Health Sciences

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-07-01
• Study First Submitted: 2020-08-05
• Study First Submitted QC: 2020-08-05
• Study First Posted: 2020-08-10
• Primary Completion: 2023-04-05
• Study Completion: 2023-04-05
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-25
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

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)

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Vaginal Mesh or Suture Exposure	Post Procedure Evaluation at 3 years	Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 3 years or grater time period. Exposure of the suture or mesh will be defined upon the visual examination in the clinic, It is expected to identify \<10% patient population during examination

Secondary Outcome Measures

Name	Time	Method
Subjective success	Post Procedure Evaluation at Minimum 2 years and 3 years	PFDI-20 (Pelvic Floor Disability Index) - Patient denies symptoms of vaginal bulging per question 3, answering "No" or "Yes". Response "Yes" leads to 4 probabilities of bothersome of condition from none to quite a bit (3 scales of symptoms and 0 as "Not at all"). Higher the value indicates a greater degree of bother. It is expected to have \<10% to have bulge symptoms by the end of the study.
Anatomic success	Post Procedure Evaluation at Minimum 2 years and 3 years	Leading edge of the prolapse is at or above the hymen to be evaluate among expected 200 participants. POP-Q assessment will be performed with surgical success being defined as apical descent less than 50% of total vaginal length
Assessment for re-intervention or re-surgery for recurrence of persistence of POP	Post Procedure Evaluation at Minimum 2 years and 3 years	No necessary use or additional surgical treatment for prolapse at any time after the initial procedure among expected 200 participants who have had participated in the original PACT study trial. Usage of pessary will be accounted as retreatment with expected \<1% patient population.

Trial Locations

Locations (5)

Augusta University; 🇺🇸 Augusta, Georgia, United States

Wake Forest Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States

Atrium Health; 🇺🇸 Charlotte, North Carolina, United States