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临床试验/NCT04658784
NCT04658784已完成不适用

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

Wake Forest University Health Sciences2 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2020年8月14日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
2
主要终点
Post-operative Posterior Compartment Pain Scores - Posterior Repair

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Age 18yo or older
  • English speaking
  • Planned posterior colporrhaphy with or without perineorrhaphy with concomitant surgical procedures allowed

排除标准

  • 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

结局指标

主要结局

Post-operative Posterior Compartment Pain Scores - Posterior Repair

时间窗: Week 6

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).

次要结局

  • Surgery Specific Adverse Events (AEs) Measured at 6-months.(month 6)
  • Post-operative Posterior Compartment Pain Scores(Month 6)
  • Change in Postoperative Sexual Function Scores(Month 6)
  • Operative Time(Time of Surgery)
  • Suture Burden(At time of surgery (Intraoperative))
  • Change in Bowel Function Scores(Baseline, Week 6, and month 6)
  • Number of Patients With Subjective Failure(Week 6 and Month 6)
  • Change in Pelvic Organ Prolapse Symptoms(Baseline, Week 6, and Month 6)
  • Number of Patients With Early Anatomic Recurrence(Week 6)
  • American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) 30-day Postoperative Complications.(30 days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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