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临床试验/NCT01262573
NCT01262573已完成4 期

Barbed Suture vs Smooth Suture for Vaginal Cuff Closure, a Randomized Trial

Brigham and Women's Hospital2 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2010年12月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
64
试验地点
2
主要终点
Vaginal Cuff Closure Time

研究概览

简要总结

This study compares outcomes among patients having a total laparoscopic hysterectomy. This involves removing the uterus and cervix using a laparoscopic or keyhole technique. The top of the vagina is routinely sutured closed after this procedure and this study is comparing two different suture materials for this purpose. One suture material is a barbed suture that has the advantage of maintaining good tension and closure on the wound. The other is a standard smooth suture that is commonly used for this procedure. The investigators are comparing the time it takes to close the vaginal cuff, as well as bleeding after surgery and the healing of the top of the vagina.

详细描述

Barbed suture has been used to close the vaginal vault for almost 3 years now, and a few preliminary studies report positive outcomes. Unfortunately, the retrospective nature of these studies may present outcomes in an overly positive light, since some of the patients may not be able to remember all the potential complications or problems they may have had in the immediate postoperative period (recall bias). The current standard of care for vaginal cuff closure appears to be to use Vicryl suture although practices vary widely.

The specific aim of this study is to evaluate whether the use of barbed suture facilitates the laparoscopic closure of the vaginal cuff during a total laparoscopic hysterectomy.

The inclusion criteria for our study include all patients who are planned for a total laparoscopic hysterectomy due to benign conditions such as symptomatic uterine fibroids, abnormal uterine bleeding, endometriosis and pelvic pain.

The laparoscopic hysterectomy will proceed as per routine. For vaginal cuff closure with barbed suture we will use a 0 polydioxanone (PDO) bidirectional barbed suture on a 36 mm half-circle taper point needle. For cuff closure with Vicryl, we plan to use 2/0 Vicryl with the vaginal cuff closure proceeding in a similar fashion as with the barbed suture. Regardless of suture material used it is important to obtain a full thickness bite with a 1 cm margin on the vagina mucosa on each bite.

Patients will be stratified to either closure by the attending or the resident or fellow under the supervision of the attending. The resident or fellow will have 15 minutes to complete the vaginal cuff closure. If they are not able to complete it within that time frame, the attending will take over and complete the vaginal cuff closure. This is to avoid adding excess operating time to the procedure due to having a trainee performing a portion of the procedure. Patients will also be asked to complete a short survey regarding dyspareunia as well as a standardized sexual function questionnaire (FSFI) prior to surgery and 3 months after surgery to evaluate if the use of barbed suture affects this in any way. Further we will also inquire about male dyspareunia before and after surgery for the same reason.

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
Single (Participant)

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

  • Patients having a total laparoscopic hysterectomy for benign conditions

排除标准

  • Malignancy

结局指标

主要结局

Vaginal Cuff Closure Time

时间窗: During the surgical procedure

Average time (measured in minutes)

次要结局

  • Dyspareunia(Postoperative)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jon I. Einarsson

Chief, Division of Minimally Invasive Gynecology

Brigham and Women's Hospital

研究点 (2)

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