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临床试验/NCT05174988
NCT05174988已完成不适用

Reducing Postoperative Bleeding After Hysterectomy Via Independent Closure of Vaginal Cuff Angles

Texas Tech University Health Sciences Center, El Paso2 个研究点 分布在 1 个国家目标入组 117 人开始时间: 2022年1月31日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
117
试验地点
2
主要终点
postoperative bleeding frequency

研究概览

简要总结

The investigators propose prospectively evaluating if adding separate sutures to the angles of the vaginal cuff before running barbed suture reduces the incidence of patient's perception of bleeding after surgery.

详细描述

Hysterectomy is the most common surgical procedure in the United States, with over 600,000 performed annually.1 There has been a dramatic improvement in expected postoperative course secondary to the advancement of minimally invasive gynecologic surgery.2 With the advent of laparoscopy and robotic surgery, even the most complex cases can be successfully performed via a minimally invasive approach. What used to be a major surgery that required a prolonged inpatient stay has become an outpatient procedure where patients are discharged home a few hours after the operation.3 Although the recovery period is shorter than in the past, there are still some postoperative complaints that are relatively common, and can impair quality of life. One of them is postoperative vaginal bleeding. Although this can be a sign of a more serious problem such as vaginal cuff dehiscence, the grand majority of times it is related to granulation tissue in the vaginal cuff that although may be self-limiting, can be bothersome and concerning to patients. Not only does this bleeding impair quality of life, but it's one of the most common reasons for emergency room visits after surgery. Multiple studies have shown that postoperative vaginal bleeding and return to the hospital significantly affect patient satisfaction. 4,5 Anecdotally, bleeding originates from granulation tissue at the angles of the closure, although there hasn't been any studies specifically investigating this. A common approach to laparoscopic cuff closure involves a running barbed suture, with or without separate closure of the lateral angles.6,7 Recently, laparoscopic closure of the vaginal cuff was found to be superior when compared to vaginal closure in terms of vaginal cuff dehiscence8. This RCT also evaluated vaginal cuff bleeding as a secondary outcome, but this was recorded as he presence of bleeding at 3 months after surgery. The closure technique in this study was a running non-barbed suture, without independent suturing of the angles. Although a running suture placed laparoscopically may provide adequate tensile strength throughout the cuff to promote healing, the tension at the corners may be less than at the center when using barbed suture, hence potentially increasing the risk of bleeding. Furthermore, the second angle may be more difficult to access when the remainder of the cuff is re-approximated.

The investigators propose prospectively evaluating if adding separate sutures to the angles of the vaginal cuff before running barbed suture reduces the incidence of patient's perception of bleeding after surgery.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 60 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • • Pre-menopausal patients scheduled to undergo hysterectomy via laparoscopic/robotic approach for benign indications (Ages 18-60, who have had at least one menstrual cycle in the last year).

排除标准

  • Patient's that incur in an intraoperative bowel or urologic injury during the hysterectomy that requires repair. If injury occurs after randomization (during vaginal cuff closure), this will be recorded and reviewed by the study's safety officer
  • Patients scheduled to undergo a concomitant vaginal procedure (Mid-urethral sling, anterior/posterior repair)
  • Patients scheduled to undergo pelvic floor repair (utero-sacral ligament suspension)
  • Patients with known preoperative malignancy
  • Patients in which a total hysterectomy is not completed

结局指标

主要结局

postoperative bleeding frequency

时间窗: 10-20 days post intervention

Survey regarding postoperative vaginal bleeding- only if they are experiencing bleeding (categorical including Daily \| Most days \| Infrequent

postoperative bleeding volume

时间窗: 10-20 days post intervention

Survey regarding postoperative vaginal bleeding- only if they are experiencing bleeding (categorical including Only when using restroom\| Spotting throughout day \| More than spotting

pain quantification on 0-10 scale

时间窗: 10-20 days post intervention

Pelvic pain scale from 0-10 assessed at postoperative visit, with 10 representing worse pain imaginable, and 0 representing no pain

prolonged bleeding

时间窗: 90-110 days after intervention

yes or no if any vaginal bleeding in the last 2 weeks

次要结局

  • ER visits(90-110 days)
  • PainSF36(90-110 days)
  • Pain with sex on a 0-10 scale(90-110 days after intervention)
  • General healthSF36(90-110 days)
  • Physical functioningSF36(90-110 days)
  • Role limitations due to physical healthSF36(90-110 days)
  • Operative time(During the surgery. Start time begins when first suture and sewing instruments are in abdomen with the intention of closing vaginal cuff. Stop time is when last suture pertaining to vaginal cuff closure/apex stitches is cut.)

研究者

发起方
Texas Tech University Health Sciences Center, El Paso
申办方类型
Other
责任方
Principal Investigator
主要研究者

Steven Radtke

Assistant Professor

Texas Tech University Health Sciences Center, El Paso

研究点 (2)

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