Permanent Versus Delayed-Absorbable Monofilament Suture

Hysterectomy Clinical Trial

— E-PACT  

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 Details — Status: Completed

Administrative data

• NCT number: NCT04506177
• Other study ID #: IRB00036663
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: April 5, 2023

Study information

• Verified date: January 2024
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 5, 2023
• Est. primary completion date: April 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hysterectomy
• Sacrocolpopexy

Locations

Country	Name	City	State
United States	Augusta University	Augusta	Georgia
United States	University of North Carolina	Chapel Hill	North Carolina
United States	Atrium Health	Charlotte	North Carolina
United States	Northwestern University	Chicago	Illinois
United States	Wake Forest Health Sciences	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaginal Mesh or Suture Exposure	Total number of participants (96% with permanent and 86% absorbable suture) will be examined and evaluated for vaginal mesh and/or suture exposure at 2 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	Post Procedure Evaluation at Minimum 2 years
Primary	Vaginal Mesh or Suture Exposure	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	Post Procedure Evaluation at 3 years
Secondary	Anatomic success	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	Post Procedure Evaluation at Minimum 2 years and 3 years
Secondary	Subjective success	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.	Post Procedure Evaluation at Minimum 2 years and 3 years
Secondary	Assessment for re-intervention or re-surgery for recurrence of persistence of POP	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.	Post Procedure Evaluation at Minimum 2 years and 3 years