Barbed-suture Efficiency Study for Sacrocolpopexy

Study Overview
=================
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.

Official Title
-----------------
BEST: Barbed-suture Efficiency Study for Sacrocolpopexy

Conditions
-----------------
Prolapse; Female

Intervention / Treatment
-----------------
* Procedure: Non-barbed delayed absorbable suture
* Procedure: Barbed delayed absorbable suture


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Non-barbed delayed absorbable suture<br>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<br>* 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.<br>|
| Experimental: Barbed delayed absorbable suture<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Year 1 | 
| 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. | Year 1 | 
| 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 | Week 6 | 
| 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 | Day 1 | 
| 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) | Year 1 | 
| 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. | Year 1 | 
| 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. | Year 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sacrocolpopexy, pelvic organ prolapse, vaginal mesh attachment