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NCT02888093 · ClinicalTrials.gov registry record · NA
A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension
A NA study, sponsored by Joseph Kowalski.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT02888093 is a NA study that has completed, run by Joseph Kowalski. The registered enrollment target is 44 participants.
The verdict
NCT02888093, a NA study, has completed, sponsored by Joseph Kowalski.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. However, permanent suture use in this vaginal application can result in some minor complication such as persistent vaginal spotting, vaginal discharge and dyspareunia. Subsequent reports on this procedure have utilized delayed-absorbable sutures in order to avoid these complications. Retrospective studies are conflicting as to whether or not absorbable suture provides as durable an anatomic outcome as permanent suture. There are currently no high-quality, prospective studies that have evaluated outcomes of permanent and absorbable suture for uterosacral ligament suspension. This study will recruit women scheduled to undergo USLS with or without other prolapse or anti-incontinence procedures. Participants will be randomized 1:1 to permanent or absorbable suture. Follow up will occur at 6 weeks and 12 months post-operatively. The primary outcome will be Pelvic Organ Prolapse Quantification Exam (POP-Q) point C as measured at the 12 month follow up visit. Subjects and assessors will be blinded.
Interventions
- DEVICE Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-10 |
| Est. Completion | 2018-11 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02888093
The ClinicalTrials.gov registry entry for NCT02888093 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Joseph Kowalski, which has 2 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) is the first listed.
NCT02888093 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02888093 about?
NCT02888093 is a clinical study titled "A Randomized Controlled Trial of Permanent vs Absorbable Suture for Uterosacral Ligament Suspension". Uterosacral ligament suspension (USLS) is a commonly performed, vaginal surgery for the correction of female pelvic organ prolapse. The original description of this procedure included the use of permanent sutures. However, permanent suture use in this vaginal application can result in some minor com...
What is the current status of trial NCT02888093?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2016-10. Estimated completion is 2018-11.
What interventions are being tested in trial NCT02888093?
The interventions under investigation include: Absorbent suture (polydioxanone) and Permanent suture (Gore-Tex CV2) (DEVICE).
Who is sponsoring clinical trial NCT02888093?
This trial is sponsored by Joseph Kowalski, which has 2 total clinical trials registered on ClinicalTrials.gov.
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