Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy

NCT04658784 | Completed Results DMC FDA Device

• 2 other identifiers: IRB00082745#04-20-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rectocele

Keywords

pelvic organ prolapse; barbed suture; posterior colporrhaphy; posterior repair; pain

Outcome Measures

Primary Outcomes (1)

• Post-operative Posterior Compartment Pain Scores - Posterior Repair

  To compare delayed absorbable barbed suture versus non-barbed delayed absorbable suture at the time of posterior repair on post-operative posterior compartment pain scores, as measured by the Visual Analog Scale (VAS).The VAS is a validated scale that is ranges from 0-100mm. 0mm is equivalent to "no pain" and is located on the left. 100mm is equivalent to "worst possible pain" and is located on the right. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100).

  Week 6

Secondary Outcomes (10)

• Post-operative Posterior Compartment Pain Scores

  Month 6

• Operative Time

  Time of Surgery

• Suture Burden

  At time of surgery (Intraoperative)

• Change in Bowel Function Scores

  Baseline, Week 6, and month 6

• Change in Pelvic Organ Prolapse Symptoms

  Baseline, Week 6, and Month 6

Study Arms (2)

Intervention

EXPERIMENTAL

Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic

Device: 2-0 dioxanone, glycolide and trimethylene carbonate

Control

ACTIVE COMPARATOR

Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon

Device: 2-0 polydioxanone

Interventions

2-0 dioxanone, glycolide and trimethylene carbonate DEVICE

delayed absorbable, monofilament barbed suture

Also known as: 2-0 V-Loc 90TM (Medtronic)

Intervention

2-0 polydioxanone DEVICE

delayed absorbable, monofilament non-barbed suture

Also known as: 2-0 PDS® (Ethicon)

Control

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: This study involves women undergoing surgery for pelvic organ prolapse.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women
• Age 18yo or older
• English speaking
• Planned posterior colporrhaphy with or without perineorrhaphy with concomitant surgical procedures allowed

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead

Study Sites (1)

Atrium Health

Charlotte, North Carolina, 28207, United States

Location

Related Publications (28)

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MeSH Terms

Conditions

Rectocele; Pelvic Organ Prolapse; Pain

Condition Hierarchy (Ancestors)

Rectal Diseases; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Prolapse; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Dr. Amanda Merriman
• Organization: Ascension Saint Thomas Medical Group

amanda.yacko@gmail.com

615-397-6919

Study Officials

• Amanda L Merriman, MD

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2020
• First Posted: December 8, 2020
• Study Start: August 14, 2020
• Primary Completion: November 5, 2021
• Study Completion: December 15, 2022
• Last Updated: May 6, 2023
• Results First Posted: October 5, 2022

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)