Barbed Versus Standard Suture for Vaginal Cuff Closure After Total Laparoscopic Hysterectomy: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,614
- 试验地点
- 2
- 主要终点
- Vaginal cuff dehiscence
研究概览
简要总结
Hysterectomy is one of the most common surgical procedures performed worldwide, with more than 400,000 hysterectomies performed annually in the United States. As a consequence, even uncommon complications can affect large numbers of patients. Among potentially life-threatening events, vaginal cuff dehiscence complicates 0.14-1.38% of procedures, and any vaginal cuff complications (dehiscence, hematoma, bleeding, infection) are estimated to affect 4.7-9.8% of patients. In this scenario, any preventive strategy can provide clinically relevant benefits. Regarding colporrhaphy, only the adoption of a laparoscopic approach instead of a vaginal approach is supported by high-quality evidence. Our group demonstrated that the laparoscopic closure of the vaginal cuff after total laparoscopic hysterectomy reduces the incidence of vaginal cuff complications.
Among other potentially effective interventions, the use of barbed sutures was associated with a lower incidence of vaginal cuff dehiscence than the standard suture. In a recent meta-analysis, the use of barbed sutures has been associated with a pooled incidence of vaginal cuff dehiscence of 0.4% versus 2% after a traditional vaginal suture. However, this evidence is limited because most pooled studies were retrospective, and only two were randomized controlled trials. Moreover, these two randomized controlled trials had a very small sample size and were not powered to detect clinically relevant differences. On that basis, despite the promising utility of barbed sutures for vaginal cuff closure after total laparoscopic hysterectomy, the choice of the type of suture is not evidence-based but still guided by personal opinions, as well as by the preference and habits of the operators.
Therefore, this study aims to investigate whether the laparoscopic vaginal cuff closure with barbed suture determines a lower incidence of vaginal cuff dehiscence and complications than conventional sutures after total laparoscopic hysterectomy.
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)
盲法说明
The surgeon will not be blinded. Conversely, patients and co-investigators who will assess study outcomes and perform patients' follow-ups will be masked regarding the allocation arm until the study's conclusion.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients undergoing elective total laparoscopic hysterectomy
- •Surgery performed for the treatment of benign pathology
- •Age > 18 years
- •Surgery performed by laparoscopy
- •Signature of informed consent
排除标准
- •Patients undergoing emergent surgery
- •Patients candidates for hysterectomy for oncological indication
- •Patients who underwent previous radiation therapy
- •Patients allergic to the suture material used in the study
- •Patients unable to express adequate informed consent to participate in the study
结局指标
主要结局
Vaginal cuff dehiscence
时间窗: 90 days after surgery
Any partial or total separation of the vaginal cuff
次要结局
- Vaginal cuff complications(90 days after surgery)
- Intraoperative blood loss(During surgery)
- 30-day post-surgical morbidity(30 days after surgery)
- Hospital stay(From the date of hospital admission to the date of hospital discharge.)
- Operative time(During surgery)
- Quality of life index(90 days after surgery)
- Sexual function(90 days after surgery)
研究者
Stefano Uccella
Associate Professor
Universita di Verona