CompletedNot Applicable

Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy

United States72 participantsStarted 2020-08-14

Plain-language 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.

Who can participate

Age range18 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Post-operative Posterior Compartment Pain Scores - Posterior Repair

Timeframe: Week 6

Trial details

NCT IDNCT04658784

SponsorWake Forest University Health Sciences

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-11-05

Results submitted2022-07-01

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