Sexuality After Tubal Sterilization by Conventional Abdominal Laparoscopy or Vaginal Natural Orifice Transluminal Endoscopy (vNOTES) : a Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- quality of sexual life
研究概览
简要总结
The goal of this clinical trial is compare the quality of sexual life at 6 months after tubal ligation, depending on whether it was performed by abdominal laparoscopy or by vNOTES, on the basis of a non-inferiority hypothesis. Participants will answer on the FSFI-19 questionnaire and quality of sexual life will be evaluated according to the score obtained at 6 months post-operative compared to pre-operative.
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
- 否
入选标准
- •Adult woman, eligible for tubal ligation by total salpingectomy or tubal section coagulation, sexually active at the time of inclusion
- •Able to give informed consent to participate in research
- •Affiliated to a social security system.
排除标准
- •Current pregnancy or breastfeeding
- •Indications of another concomitant surgical procedure (other than procedure on the appendix)
- •History of upper genital infection
- •Proven or suspected rectovaginal endometriosis on clinical examination
- •History of rectal surgery
- •Virgin patient
- •Any concomitant pathology deemed incompatible with the study.
- •Uncured COVID or SARS-COv2 positivity dated less than 3 days prior to surgery.
- •Protected adult patient, under guardianship or curatorship
- •Patients not affiliated to the social security system
- •Patients who do not speak French
- •Patients under legal protection
- •Refusal to participate.
研究组 & 干预措施
vnotes
干预措施: vnotes (Procedure)
laparoscopic
干预措施: laparoscopy (Procedure)
结局指标
主要结局
quality of sexual life
时间窗: 6 months
To compare, on the basis of a non-inferiority hypothesis, the quality of sexual life at 6 months after tubal ligation, depending on whether it is performed by abdominal laparoscopy or by vNOTES, using the Female Sexual Function Index - 19 (FSFI-19) questionnaire (19 questions with 6 possible answers for each, with scores ranging from 0=worse outcome to 5=better outcome).
次要结局
- patient satisfaction(6 months)
- characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes)(6 months)
- postoperative pain(6 months)
- consumption of peroperative analgesics.(6 months)
- consumption of postoperative analgesics.(6 months)
- per and post-operative complications(6 months)
- quality of life after surgery(6 months)
- number of days of sick leave(6 months)
- characteristics of the course of surgery for tubal ligation (duration of installation and intervention in minutes)(6 months)
- postoperative pain(6 months)
- consumption of peroperative analgesics.(6 months)
- consumption of postoperative analgesics.(6 months)
- per and post-operative complications(6 months)
- patient satisfaction(6 months)
- quality of life after surgery(6 months)
- number of days of sick leave(6 months)