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Barbed-suture Efficiency Study for Sacrocolpopexy (BEST)

Primary Purpose

Prolapse; Female

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Non-barbed delayed absorbable suture
Barbed delayed absorbable suture
Sponsored by
Wake Forest University Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prolapse; Female focused on measuring sacrocolpopexy, pelvic organ prolapse, vaginal mesh attachment

Eligibility Criteria

21 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Wake Forest University Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Non-barbed delayed absorbable suture

Barbed delayed absorbable suture

Arm Description

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

Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP

Outcomes

Primary Outcome Measures

Time to complete vaginal graft attachment
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)

Secondary Outcome Measures

Composite success rate
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
Vaginal mesh exposure at 1 year
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.
Adverse outcome scores
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
Surgeon satisfaction with technique
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
Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory
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)
Patient change in quality of life, symptom bother, and sexual functioning - (PISQ-sf) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form
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.
Patient change in quality of life, symptom bother, and sexual functioning - (PFIQ-sf7) Pelvic Floor Impact Questionnaire Short form
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.

Full Information

First Posted
February 25, 2023
Last Updated
June 28, 2023
Sponsor
Wake Forest University Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05760794
Brief Title
Barbed-suture Efficiency Study for Sacrocolpopexy
Acronym
BEST
Official Title
BEST: Barbed-suture Efficiency Study for Sacrocolpopexy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 21, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
August 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prolapse; Female
Keywords
sacrocolpopexy, pelvic organ prolapse, vaginal mesh attachment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Plan to enroll 52 participants with intention to treat 26 in each group - Participants will be randomized to delayed-absorbable barbed suture (2-0 V-Loc) versus delayed-absorbable interrupted suture (2-0 PDS).
Masking
ParticipantOutcomes Assessor
Masking Description
Patient will be masked to their allocation and post-operative examiners will be masked at the 6 week, 6 month, and 12 month visits
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-barbed delayed absorbable suture
Arm Type
Experimental
Arm Description
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
Arm Title
Barbed delayed absorbable suture
Arm Type
Experimental
Arm Description
Participants assigned to Barbed delayed absorbable suture group will have Barbed delayed absorbable suture used for vaginal mesh attachment at time of SCP
Intervention Type
Procedure
Intervention Name(s)
Non-barbed delayed absorbable suture
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Barbed delayed absorbable suture
Intervention Description
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.
Primary Outcome Measure Information:
Title
Time to complete vaginal graft attachment
Description
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)
Time Frame
Day 1
Secondary Outcome Measure Information:
Title
Composite success rate
Description
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
Time Frame
Year 1
Title
Vaginal mesh exposure at 1 year
Description
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.
Time Frame
Year 1
Title
Adverse outcome scores
Description
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
Time Frame
Week 6
Title
Surgeon satisfaction with technique
Description
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
Time Frame
Day 1
Title
Patient change in quality of life, symptom bother, and sexual functioning - (PFDI-20) Pelvic Floor Distress Inventory
Description
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)
Time Frame
Year 1
Title
Patient change in quality of life, symptom bother, and sexual functioning - (PISQ-sf) Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire short form
Description
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.
Time Frame
Year 1
Title
Patient change in quality of life, symptom bother, and sexual functioning - (PFIQ-sf7) Pelvic Floor Impact Questionnaire Short form
Description
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.
Time Frame
Year 1
Other Pre-specified Outcome Measures:
Title
Mesh related adverse events and surgical success compared to PACT trial
Description
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.
Time Frame
Year 1

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
women with symptomatic uterovaginal or vaginal vault prolapse, without a prior history of mesh repair, who have completed childbearing, are seeking surgical management, and are willing to proceed with abdominal placement of permanent synthetic mesh.
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sachin Vyas, PhD
Phone
336-713-4098
Email
svyas@wakehealth.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katherine L Woodburn, MD
Organizational Affiliation
Wake Forest University Health Sciences
Official's Role
Principal Investigator
Facility Information:
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sachin N Vyas, MS, PhD
Phone
336-713-4098
Email
svyas@wakehealth.edu

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
23633316
Citation
Maher C, Feiner B, Baessler K, Schmid C. Surgical management of pelvic organ prolapse in women. Cochrane Database Syst Rev. 2013 Apr 30;(4):CD004014. doi: 10.1002/14651858.CD004014.pub5.
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Results Reference
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PubMed Identifier
15902189
Citation
Paraiso MF, Walters MD, Rackley RR, Melek S, Hugney C. Laparoscopic and abdominal sacral colpopexies: a comparative cohort study. Am J Obstet Gynecol. 2005 May;192(5):1752-8. doi: 10.1016/j.ajog.2004.11.051.
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Barbed-suture Efficiency Study for Sacrocolpopexy

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