N/A
Completed N=72
Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy
Rectocele
Source: ClinicalTrials.gov NCT04658784 ↗
Enrolled (actual)
72
Serious AEs
2.8%
Results posted
Oct 2022
Primary outcomePrimary: Post-operative Posterior Compartment Pain Scores - Posterior Repair — 32; 29; 2; 4 Participants — p=0.32
Summary
The aim of this randomized clinical trial is to compare barbed suture versus non-barbed suture at the time of posterior repair on postoperative pain scores as measured by a visual analog scale (VAS) at 6 weeks.
Study participants are randomized to use of barbed suture (2-0 V-Loc 90TM, Medtronic) or non-barbed suture (2-0 Polydioxanone, PDS® EthiconTM) in a standardized technique for posterior colporrhaphy at the time of posterior repair.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Post-operative Posterior Compartment Pain Scores - Posterior Repair |
32; 29; 2; 4; 1; 2 | 0.32 |
| SECONDARY Post-operative Posterior Compartment Pain Scores |
33; 26; 1; 1; 0; 1 | 1.0 |
| SECONDARY Operative Time |
146; 168; 21; 20.5 | — |
| SECONDARY Suture Burden |
10.5; 26.9 | — |
| SECONDARY Change in Bowel Function Scores |
36.4; 36.6; 18.1; 18.1; -18.2; -18.6 | 1.0 |
| SECONDARY Change in Pelvic Organ Prolapse Symptoms |
53.4; 52.1; 13.8; 11.2; -39.6; -40.9 | 1.0 |
| SECONDARY Change in Postoperative Sexual Function Scores |
28.1; 26.9; 33.1; 31.7; 3.9; 4.6 | 1.0 |
| SECONDARY Number of Patients With Early Anatomic Recurrence |
0; 0 | — |
| SECONDARY Number of Patients With Subjective Failure |
0; 0; 1; 2 | — |
| SECONDARY American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. |
5; 3; 0; 1; 1; 0 | — |
| SECONDARY Surgery Specific Adverse Events (AEs) Measured at 6-months. |
4; 5; 1; 4; 2; 1 | — |
Eligibility Criteria
Inclusion Criteria
- Women
- Age 18yo or older
- English speaking
- Planned posterior colporrhaphy with or without perineorrhaphy with concomitant surgical procedures allowed
Exclusion Criteria
- Documented allergy or contraindication to use of suture material
- Prior mesh in posterior compartment
- Planned colpocleisis
- Current or prior rectovaginal fistula
- Planned sacrospinous ligament fixation procedure
- Chronic pelvic pain diagnosis
- Chronic narcotic medication use
- Active vulvodynia
- Non-English speaking
- Inability to provide informed consent
- Planned combined colorectal/anorectal surgery
Data sourced from ClinicalTrials.gov (NCT04658784). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.