Barbed Suture Versus Traditional Suture Material for Laparoscopic Myomectomy: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Operative time
研究概览
简要总结
The objective of this study is to determine if the use of a new type of barbed suture material for laparoscopic myomectomy (surgical removal of fibroids) versus the traditional approach of suturing with conventional suture material to close the uterine defect once the fibroid has been removed, improves surgical outcomes. Specifically, the investigators will investigate the effect of barbed suture on operative time, blood loss, adverse post-operative events and hospital stay.
详细描述
Although the laparoscopic myomectomy has benefits over the abdominal approach, such as less blood loss, less hemoglobin drop post-operatively, decreased post-operative pain and fewer overall complications, it is a difficult procedure, which often requires greater operative time to perform. In the current climate of attempting to reduce health care expenditures, even though the minimally invasive approach offers the advantage of reduced hospital stay, a deterrent for hospital administration and surgeons may be the increased operative time it may require. Barbed suture is a relatively new material available in gynecologic surgery. Barbs are cut into the suture with the barbs facing in a direction opposite that of the needle. The barbs allow for anchoring of the suture in tissues, which prevents migration and allows suturing without knot tying. This study will be a single-centre non-blinded randomized controlled trial comparing laparoscopic myomectomy with barbed suture versus traditional suture material.
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
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •women who are planning to undergo laparoscopic myomectomy
排除标准
- •greater than five fibroids
- •uterus extending beyond the umbilicus
- •major medical comorbidity or psychiatric illness, which could affect follow-up and/or compliance
- •patients undergoing concomitant surgical procedures at the time of myomectomy (such as resection of endometriosis or ovarian cystectomy)
- •pregnancy (all patients will have serum pregnancy testing prior to surgery)
- •patients with any suggestion of abnormal pathology on imaging or endometrial biopsy
研究组 & 干预措施
Barbed suture
干预措施: Laparoscopic myomectomy with unidirectional barbed suture (Procedure)
Traditional suture material
干预措施: Traditional suture material (Procedure)
结局指标
主要结局
Operative time
We will record the operative time from beginning to completion of suturing each fibroid separately, as well as total operative time for the entire procedure.
次要结局
- Hospital stay
- Blood loss(Intra-operative)
- Adverse events(Intra-operatively until 6 weeks post-operatively)
- Fertility and pregnancy-related outcomes(2 and 5 years post-operatively)