Barbed-suture Efficiency Study for Sacrocolpopexy (BEST)

January 24, 2024 updated by: Wake Forest University Health Sciences

BEST: Barbed-suture Efficiency Study for Sacrocolpopexy

Minimally invasive sacrocolpopexy (SCP) performed laparoscopically or with robotic assistance is associated with improved patient-centered outcomes such as faster recovery times, less pain, less bleeding, and shorter hospital stay, however at the expense of longer operating times. One of the time consuming parts of the procedure is vaginal mesh attachment.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The purpose of this research study is to compare two different suture types that are used to attach vaginal mesh that is typically used in women undergoing robotic or laparoscopic sacrocolpopexy (attachment of the vagina to the sacral promontory). The barbed suture is one continuous suture, while the delayed absorbable suture involves placing individual sutures and tying a knot for each. All women will have permanent sutures that attach the mesh to the sacral promontory, which is standard of care. The goal is to determine if the barbed delayed absorbable suture decreases the time of vaginal mesh attachment.

Study Type

Interventional

Enrollment (Estimated)

52

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • North Carolina
      • Winston-Salem, North Carolina, United States, 27157
        • Recruiting
        • Wake Forest University Health Sciences
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age ≥21
  • Subject must have apical with anterior or posterior vaginal prolapse with leading edge of prolapse to or beyond the hymen
  • Subject reports a bothersome bulge they can see or feel per Pelvic Floor Disability Index (PFDI-20), question 3, response of 2 or higher
  • Eligible for laparoscopic or robotic sacrocolpopexy
  • Desires surgical treatment for symptomatic uterovaginal or vaginal vault prolapse
  • English speaking

Exclusion Criteria:

  • Patients who are not surgical candidates due to medical comorbidities
  • Current foreign body complications (including but not limited to erosion, fistula, abscess). This covers foreign bodies of any type (e.g. synthetic and biologic including allograft, xenograft).
  • Inability to give informed consent or to complete the testing or data collection.
  • Anticipated circumstances resulting in an inability to follow up (geographic relocation, etc.).
  • Active systemic infection including any gynecologic infection, untreated Urinary Tract Infection (UTI) or tissue necrosis.
  • History of pelvic organ cancer (e.g. uterine, ovarian, bladder, or cervical).
  • Prior or currently undergoing radiation, laser therapy, or chemotherapy in the pelvic area.
  • Subject has taken systemic steroids (within the last month, steroid inhalers OK), or immunosuppressive or immunomodulatory treatment (within the last 3 months)
  • Systemic connective tissue disease (e.g. scleroderma, Marfan's syndrome, Ehlers Danhlos, collagenosis, polymyositis or polymyalgia rheumatic, lupus)
  • Chronic systemic pain that includes the pelvic area or chronic focal pain that involves the pelvis
  • Poorly controlled diabetes mellitus (DM), as indicated by Hemoglobin A1c > 9
  • Those requiring concomitant rectopexy
  • Subject is not able to conform to steep Trendelenburg position
  • Known sensitivity to polypropylene
  • History of prior prolapse repair utilizing vaginal or abdominal mesh
  • Planned vaginal mesh attachment placed transvaginally
  • History of diverticulitis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non-barbed delayed absorbable suture
Participants assigned to Non-barbed delayed absorbable suture group will have Non-barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP
Procedure: Non-barbed delayed absorbable suture
The non-barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 PDS (polydioxanone). The vaginal mesh will be attached with at least four interrupted sutures on the anterior vagina and posterior vagina.
Experimental: Barbed delayed absorbable suture
Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP
Procedure: Barbed delayed absorbable suture
The barbed delayed absorbable suture group vaginal mesh attachment will be performed with 2-0 V-Loc. The vaginal mesh will be attached with a running V-Loc on the anterior and posterior vagina.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to complete vaginal graft attachment
Time Frame: Day 1
To determine if delayed-absorbable barbed suture (2-0 V-Loc) produces a decrease in the time to achieve vaginal mesh attachment during minimally invasive SCP (with or without concomitant total hysterectomy) compared to delayed- absorbable polydioxanone (2-0 PDS) interrupted suture - time (in minutes and seconds)
Day 1

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Composite success rate
Time Frame: Year 1

To compare the 1-year composite success rates of minimally invasive sacrocolpopexy (SCP) between the two groups:

  • Anatomic success: leading edge of prolapse is at or above the hymen (POP-Q point Ba and Bp less than or equal to and vaginal apex less than 1/3 of the total vaginal length
  • Subjective success: patient denies symptoms of vaginal bulging per Pelvic Floor Distress Inventory (PFDI)-20 question 3, answering "No" or "Yes" but "Not at all" bothersome
  • Assessment for re-intervention or re-operation for recurrence or persistence of pelvic organ prolapse: No need for pessary use or additional surgical treatment for prolapse at any time after the initial procedure
Year 1
Vaginal mesh exposure at 1 year
Time Frame: Year 1
To compare the 1 year rate of vaginal mesh exposure between the two groups - Signs and symptoms of mesh exposure include vaginal or pelvic pain, vaginal discharge or bleeding, odor, recurrent infection, abscess development, dyspareunia, or pain experienced by the sexual partner. Pain is the most common presenting symptom.
Year 1
Adverse outcome scores
Time Frame: Week 6
To compare adverse outcomes, classified according to the Clavien-Dindo system, between the two groups - It consists of 7 grades (I, II, IIIa, IIIb, IVa, IVb and V) - the higher the grade; the worse the complication
Week 6
Surgeon satisfaction with technique
Time Frame: Day 1
To compare intraoperative surgeon satisfaction with technique between the two groups - satisfaction with technique will be assessed with a 10 point visual analog scale (VAS) for ease of placement, appearance of mesh attachment, and global satisfaction with the attachment type - 0 meaning difficult and 10 meaning easy
Day 1
Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory
Time Frame: Year 1
Assessment of participant changes in quality of life, symptom bother, and sexual functioning at 1 year compared to baseline - The total PFDI-20 score was classified as the absence of symptoms (score zero), symptoms with mild distress (1 to 15 points), symptoms with moderate distress (16 to 34 points), and symptoms with severe distress (35 to 40 points)
Year 1
Patient change in quality of life, symptom bother, and sexual functioning - (PISQ-sf) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form
Time Frame: Year 1
Assessment of participant changes in quality of life, symptom bother, and sexual functioning at 1 year compared to baseline - a validated general questionnaire widely used in clinical practice as a screening tool for female sexual dysfunction, as well as in clinical trials as an outcome measure. It consists of 19 items, grouped into six domains: Desire, Arousal, Lubrication, Orgasm, Satisfaction, and Pain. The total score is obtained by adding the six domain scores (range: 2.0-36.0). Higher scores in particular domains and total score indicate better sexual function.
Year 1
Patient change in quality of life, symptom bother, and sexual functioning - (PFIQ-sf7) Pelvic Floor Impact Questionnaire Short form
Time Frame: Year 1
Assessment of participant changes in quality of life, symptom bother, and sexual functioning at 1 year compared to baseline - scores range from 0-300. A lower score means there is a lesser effect on quality of life.
Year 1

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mesh related adverse events and surgical success compared to PACT trial
Time Frame: Year 1
To compare mesh-related adverse events (mesh exposure, pain) and surgical success within the first post-operative year in the BEST trial compared to historical data collected in the PACT trial.
Year 1

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Katherine L Woodburn, MD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 21, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

August 1, 2025

Study Registration Dates

First Submitted

February 25, 2023

First Submitted That Met QC Criteria

February 25, 2023

First Posted (Actual)

March 8, 2023

Study Record Updates

Last Update Posted (Actual)

January 26, 2024

Last Update Submitted That Met QC Criteria

January 24, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00093867

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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