Permanent Versus Delayed-Absorbable Monofilament Suture

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04506177

Acronym

E-PACT

Enrollment

200

Registered

2020-08-10

Start date

2020-07-01

Completion date

2023-04-05

Last updated

2024-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hysterectomy, Sacrocolpopexy

Keywords

Pelvic Organ Prolapse, Vaginal mesh

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Vaginal Mesh or Suture Exposure	Post Procedure Evaluation at Minimum 2 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 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

Secondary

Measure	Time frame	Description
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
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.
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.

Countries

United States

Outcome results