Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy

Overview

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.

Full Title of Study: “Barbed Suture Versus Non-Barbed Suture for Posterior Colporrhaphy: A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: October 22, 2021

Detailed Description

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.

Interventions

  • Device: 2-0 dioxanone, glycolide and trimethylene carbonate
    • delayed absorbable, monofilament barbed suture
  • Device: 2-0 polydioxanone
    • delayed absorbable, monofilament non-barbed suture

Arms, Groups and Cohorts

  • Experimental: Intervention
    • Receives posterior colporrhaphy closure using standardized technique with 2-0 V-Loc 90TM, Medtronic
  • Active Comparator: Control
    • Receives posterior colporrhaphy closure using standardized technique with conventional 2-0 PDS® Ethicon

Clinical Trial Outcome Measures

Primary Measures

  • Post-operative posterior compartment pain scores
    • Time Frame: 6-weeks
    • 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.

Secondary Measures

  • Post-operative posterior compartment pain scores
    • Time Frame: 6-months
    • 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.
  • Operative time
    • Time Frame: 6-weeks
    • To evaluate operative time for posterior repair in minutes
  • Postoperative suture burden
    • Time Frame: 6-weeks
    • To evaluate suture burden and pelvic pain on examination of the posterior by compartment number by measuring total amount of delayed absorbable suture used for posterior colporrhaphy in cm.
  • Change in bowel function
    • Time Frame: 6-weeks, 6-months
    • 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 is obtained by the mean value of all of the answered items within the corresponding scale (possible value 0 to 4). Score can range from 0-80. Then multiply by 25 to obtain the scale score (range 0 to 100). The higher the score the more distress.
  • Change in pelvic organ prolapse symptoms
    • Time Frame: 6-weeks, 6-months
    • 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 is obtained by the mean value of all of the answered items within the corresponding scale (possible value 0 to 4). The score can range from 0-80. Then multiply by 25 to obtain the scale score (range 0 to 100). The higher the score the more distress.
  • Change in postoperative sexual function
    • Time Frame: 6-months
    • To evaluate postoperative sexual function using the Pelvic Organ Prolapse-Urinary Incontinence Sexual Function Questionnaire (PISQ-12). Score is obtained from 0-48. To compare to the long form of the PSIQ, multiple the total score by 2.58. A lower score is associated with poorer sexual function.
  • Difference in cost of delayed absorbable sutures
    • Time Frame: 6-weeks
    • To evaluate cost of delayed absorbable suture choice based on sutures used
  • Number of patients with anatomic failure
    • Time Frame: 6 weeks
    • 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)
  • Number of patients with subjective failure
    • Time Frame: 6-weeks, 6-months
    • 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?”
  • Number of patients with adverse outcomes
    • Time Frame: 6-weeks, 6-months
    • To evaluate differences in adverse outcomes using modified Clavien-Dindo classification system

Participating in This Clinical Trial

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

Gender Eligibility: Female

This study involves women undergoing surgery for pelvic organ prolapse.

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Atrium Health
  • Provider of Information About this Clinical Study
    • Principal Investigator: Amanda Merriman, FPMRS Fellow, Junior Faculty – Atrium Health
  • Overall Contact(s)
    • Amanda L Merriman, MD, 704-304-1160, amanda.merriman@atriumhealth.org

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