N/A N=72 Randomized Double-blind Treatment

Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy

Rectocele

Bottom Line

View on ClinicalTrials.gov: NCT04658784 ↗

Enrolled (actual)

Serious AEs

2.8%

Results posted

Oct 2022

Primary outcome: Primary: Post-operative Posterior Compartment Pain Scores - Posterior Repair — 32; 29; 2; 4 Participants — p=0.32

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: 2-0 dioxanone, glycolide and trimethylene carbonate (Device); 2-0 polydioxanone (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Wake Forest University Health Sciences
Primary completion: Nov 2021

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	—

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.

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

View full record on ClinicalTrials.gov →

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.