Randomized Clinical Trial About Vaginal Cuff Dehiscence Following Total Laparoscopic Hysterectomy: Laparoscopic vs. Transvaginal Cuff Suturing
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,408
- 试验地点
- 2
- 主要终点
- VAGINAL DEHISCENCE
研究概览
简要总结
Post-hysterectomy vaginal cuff dehiscence is a rare but threatening complication.
The investigators will compare transvaginal versus laparoscopic closure of the vaginal vault at the end of a total laparoscopic hysterectomy, in order which of these two modalities of suturing is associated with a lower risk of dehiscence.
详细描述
A post-hysterectomy vaginal cuff dehiscence is defined as a partial or total separation of the margins of the vaginal cuff closure, following hysterectomy.
The recognition of the complication is made on a clinical basis. The investigators will compare the percentage of dehiscence among women who had transvaginal vs. laparoscopic suture of the vault.
The investigators will also compare the two modalities in terms of:
- duration of the vaginal closure
- risk of bleeding from the vaginal cuff
- risk of post-operative pelvic infection
- risk of re-operation
- dyspareunia
- total vaginal length
- vaginal cuff prolapse.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- 否
入选标准
- •Patients undergoing total laparoscopic hysterectomy with or without salpingo-oophorectomy
排除标准
- •Patients with gynecological malignancy (uterine and/or adnexal)
研究组 & 干预措施
TRANSVAGINAL SUTURE
INTERVENTION: Transvaginal suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using vaginal valves and needleholders.
干预措施: TRANSVAGINAL SUTURE (Procedure)
LAPAROSCOPIC SUTURE
INTERVENTION: Laparoscopic suturE of the vaginal vault at the end of a total laparoscopic hysterectomy using with laparoscopic needleholders.
干预措施: LAPAROSCOPIC SUTURE (Procedure)
结局指标
主要结局
VAGINAL DEHISCENCE
时间窗: 3 months postoperatively
Vaginal dehiscence defined as any partial or complete separation of the vaginal vault, sutured at the end of a total laparoscopic hysterectomy. This complication is diagnosed clinically, during a gynecologic visit. Every dehiscence (whether partial or total) will be considered as an outcome event and we will measure the presence/absence of dehiscence as a percentage of the total procedures.
次要结局
- VAGINAL CUFF COMPLICATIONS(3 months postoperatively)
- operative time(During Operation)
研究者
Stefano Uccella
Medical Doctor
Università degli Studi dell'Insubria