Barbed-suture Efficiency Study for Sacrocolpopexy
NCT05760794 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 52
Last updated 2025-12-02
Summary
Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.
Conditions
- Prolapse; Female
Interventions
- PROCEDURE
-
Non-barbed delayed absorbable suture
The non-barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 PDS (polydioxanone). The vaginal mesh will be attached with at least four interrupted sutures on the anterior vagina and posterior vagina.
- PROCEDURE
-
Barbed delayed absorbable suture
The barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 V-Loc. The vaginal mesh will be attached with a running V-Loc on the anterior and posterior vagina.
Sponsors & Collaborators
-
Wake Forest University Health Sciences
lead OTHER
Principal Investigators
-
Katherine L Woodburn, MD · Wake Forest University Health Sciences
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-06-21
- Primary Completion
- 2027-12-31
- Completion
- 2027-12-31
Countries
- United States
Study Locations
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