Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 145
- 试验地点
- 2
- 主要终点
- Complications per or post Operative
研究概览
简要总结
During a first consultation with an indication of total hysterectomy for a benign lesion, we will study the patient's eligibility. After explanations of the study and submission of the forms, the patient will benefit from a second consultation with the investigator to give her consent. The surgeon will randomize the patient using RedCap computer software. The patient will then be referred either to the vNOTES group or to the laparoscopy group. The surgery will be performed by surgeons called "expert" in one of the ways first. For this, it will be necessary to have performed at least 25 hysterectomies by laparoscopy or vNOTES. The surgery will take place using the usual techniques. Per and postoperative complications will be studied and noted up to six months postoperatively.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Adult woman eligible for total hysterectomy for benign lesions with or without bilateral adnexectomy.
- •Able to give informed consent to participate in research.
- •Affiliation to a Social Security scheme.
排除标准
- •Pregnant or breastfeeding women
- •Contraindication to the laparoscopic approach
- •Contraindication to first vNOTES, in particular: virginity, history of rectal surgery, rectovaginal endometriosis, high active genital infection
- •Indications for another concomitant surgical procedure (other than procedure on the appendix)
- •Indication of hysterectomy for malignant lesion.
- •Any concomitant pathology deemed incompatible with the study.
- •COVID not cured or SARS-COv2 positivity dating less than 3 days before surgery.
- •Adult patient protected, under guardianship or curatorship or legal safeguard
- •Refusal of participation.
研究组 & 干预措施
vNOTES
In this Arm, patient will have the hysterectomy by vNOTES (vaginal natural orifices Transluminal surgery). It's the new type of surgery that we want prove the no-inferiority.
干预措施: vNOTES (Procedure)
Laparoscopy
In this Arm, patient will have the traditional hysterectomy by laparoscopy. This is the type of surgery that we realize everyday.
干预措施: Laparoscopy (Procedure)
结局指标
主要结局
Complications per or post Operative
时间窗: one month after surgery
Appearance of a per or post operative complication: bleeding, digestive or urinary sore or infection
次要结局
- Measure of pain(Until one month)
- Duration of operation(one day)
- Assessment of quality of life(Six month)
- Assessment of satisfaction(Six month)
- Duration of work stoppage(one month)