Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy

Study Overview
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Brief Summary
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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.

Detailed Description
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Pelvic organ prolapse (POP) is a growing concern for the aging female population, and symptomatic women often require surgical intervention. Approximately 200,000 surgical procedures for POP are performed annually in the United States. This number is anticipated to increase with the growth in the aging population.1 Surgical prolapse repairs are often categorized into either mesh augmented or native tissue repairs. During a native tissue repair, the surgeon uses a woman's natural tissue to repair the prolapse without augmenting the repair with synthetic mesh. Women often have post-operative pain with native tissue posterior colporrhaphy. Native tissue posterior repairs are performed to address symptomatic posterior compartment prolapse, defects in the rectovaginal fibromuscularis, and/or a widened genital hiatus. This type of repair may improve obstructed defecatory dysfunction and bulge symptoms, but can be associated with postoperative pelvic pain and dyspareunia. Paraiso et al evaluated three surgical techniques for posterior colporrhaphy (site-specific, midline plication, and porcine graft) and found no difference in overall symptom improvement, quality of life, and post-operative sexual function. Regardless of the technique used, a posterior colporrhaphy can cause considerable postoperative pain and can contribute to de novo dyspareunia in 9-20% of women. Most studies evaluating pain after posterior colporrhaphy tend to focus on various methods of analgesia and surgical technique rather than the suture materials used. Suture choice may contribute to postoperative pain at the time of posterior colporrhaphy. There are few studies evaluating suture in the posterior compartment with no defined standard suture material for posterior colporrhaphy. Available studies, when comparing subjective bulge and quality of life outcomes, do not demonstrate superiority of one suture type over the other. Delayed absorbable suture has the benefit of retaining tensile strength for approximately 3 months. Delayed absorbable suture material itself, however, can remain in place for up to 8 months. These properties may decrease postoperative pain by decreasing knot burden. Barbed suture has been successfully applied to vaginal cuff closure, myomectomy, sacrocolpopexy mesh attachment, and closure of bowel and bladder injuries with demonstrated reduced operative times. To date, no studies have evaluated the impact of barbed suture on postoperative pain or surgical time after posterior colporrhaphy. The primary objective for this study is 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), at 6 weeks Secondary objectives include a comparison of VAS pain scores in the posterior compartment at 6-months, evaluation of operative time for posterior repair in minutes, evaluation of suture burden and pelvic pain on examination of the posterior compartment, evaluation of pain versus the length of a repair, evaluation of postoperative patient quality of life (QoL) using series of standardized questionnaires, evaluation of suture cost, and a comparison of anatomical and surgical failure in the posterior compartment. Participants will be approached for participation preoperatively. Baseline demographic data will be abstracted from the medical record. A baseline Pelvic Organ Prolapse Quantification (POP-Q) and pelvic myofascial exam will be performed. Baseline VAS and validated questionnaires: Pelvic Floor Distress Inventory-20 (PFDI-20) sub-scales Colorectal-Anal Distress Inventory-8 (CRADI-8) and Pelvic Organ Prolapse Distress Inventory-6 (POPDI-6) and Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire- 12 (PISQ-12 )will be completed. Participants will be randomized in the operating room after posterior vaginal dissection to either barbed or non-barbed suture in a standardized technique. All concurrent minimally invasive pelvic reconstructive surgical procedures are allowed. Randomization will be stratified for minimally invasive (robotic or laparoscopic) versus vaginal surgery. Perioperative care is standardized. Participants will be scheduled for a post-operative follow up visit at approximately 6 weeks. At this visit they will have a structured postoperative interview and pelvic examination, including POP-Q, standardized assessment of suture burden and myofascial trigger points. They will also complete a VAS and validated questionnaires. Participants will be called at approximately 6 months after their original surgery. They will have a structured interview and complete VAS and complete validated questionnaires. Adverse postoperative outcomes will be collected at each visit. Investigators will use a standard deviation estimate of 23.4mm to detect a difference on a 100mm VAS for pain. Accounting for a 15% drop-out rate, the investigators aim to enroll 64 participants with 32 in each group.

Official Title
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Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy: A Randomized Controlled Trial

Conditions
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Rectocele

Intervention / Treatment
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* Device: 2-0 dioxanone, glycolide and trimethylene carbonate
* Device: 2-0 polydioxanone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic | Device: 2-0 dioxanone, glycolide and trimethylene carbonate<br>* delayed absorbable, monofilament barbed suture<br>* Other names: 2-0 V-Loc 90TM (Medtronic);|
| Active Comparator: Control<br>Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon | Device: 2-0 polydioxanone<br>* delayed absorbable, monofilament non-barbed suture<br>* Other names: 2-0 PDS® (Ethicon);|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Posterior Compartment Pain Scores | To compare visual analog scale (VAS) pain scores in the posterior compartment. 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, low pain, moderate pain and high pain. Reported as categorical variable no pain (VAS 0), low pain (VAS 1-33), moderate pain (VAS 34-66), and high pain (VAS 67-100). | Month 6 | 
| Operative Time | To evaluate operative time for posterior repair in minutes. | Time of Surgery | 
| Suture Burden | To evaluate amount of suture burden present at time of surgery in posterior by compartment by measuring total amount of delayed absorbable suture used for posterior colporrhaphy in centimeters. | At time of surgery (Intraoperative) | 
| Change in Bowel Function Scores | To evaluate change in bowel function using the Pelvic Floor Distress Inventory- 20 (PFDI-20) sub-scale Colorectal-Anal Distress Inventory-8 (CRADI-8). Total score (range 0 to 100) with the higher the score the more distress. | Baseline, Week 6, and month 6 | 
| Change in Pelvic Organ Prolapse Symptoms | To evaluate change in pelvic organ prolapse symptoms using the Pelvic Floor Distress Inventory- 20 (PFDI-20) sub-scale the Pelvic Organ Prolapse Distress Inventory- 6 (POPDI-6). Total score (range 0 to 100) with the higher the score the more distress. | Baseline, Week 6, and Month 6 | 
| Change in Postoperative Sexual Function Scores | To evaluate postoperative sexual function using the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Total score (range 0 to 48) with a lower score associated with poorer/worse sexual function. | Month 6 | 
| Number of Patients With Early Anatomic Recurrence | To evaluate anatomical failure of posterior compartment using a standard definition of anatomical cure will be defined as Ba or Bp at </= 0 on POP-Q examination (i.e.at or beyond hymenal ring) | Week 6 | 
| Number of Patients With Subjective Failure | To evaluate subjective failure of posterior compartment using a negative response on POPDI-6 portion of the PFDI-20 questionnaire to questions: Do you usually have a sensation of bulging or protrusion from the vaginal area? and Do you usually have a bulge or something falling out that you can see or feel in the vaginal area? | Week 6 and Month 6 | 
| American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications. | To evaluate differences in adverse outcomes, using number of adverse events (AEs) as defined by the American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day postoperative complications criteria. These criteria were reviewed at the week 6 data collection time interval. | 30 days | 
| Surgery Specific Adverse Events (AEs) Measured at 6-months. | To evaluate differences in adverse outcomes, using number of surgery specific adverse events. | month 6 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pelvic organ prolapse, barbed suture, posterior colporrhaphy, posterior repair, pain