Prospective, Controlled, Randomized Study Evaluating the Success Rate of Outpatient Management of the Total Benign Hysterectomy by Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Compared to Each of the Two Laparoscopic Routes (Conventional and Robot-assisted).
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1
- 试验地点
- 2
- 主要终点
- Compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the robot-assisted laparoscopic route.
研究概览
简要总结
Benign total hysterectomy is one of the most commonly performed gynecological surgery.
Conventionally performed by a classical surgical approach, it is now provided routinely and for several years by laparoscopy and more recently by Robotic-Assisted Laparoscopy.
A third minimally invasive option is currently being developed and proposed to avoid trans-peritoneal access, using a vaginal trans-laparoscopic technique, defined by the name V-NOTES (Vaginal-Natural Orifice Transluminal Endoscopic Surgery).
These minimally invasive approaches have simplified this intervention on many surgical and anesthetic parameters (signing, surgical trauma, pain and post-operative ileus, recovery of autonomy) and consider possible management in the outpatient sector.
This study aims at enrolling women for which a total hysterectomy with or without annexectomy for the treatment of a benign pathology must be scheduled.
The objective of the study is to compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the laparoscopic route assisted robot.
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
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Participant aged 18 years old and over
- •Participant for whom a total hysterectomy with or without adnexectomy for the treatment of a benign pathology must be scheduled
- •Participant with no contraindication to being operated on by one of the three approaches under study (conventional laparoscopy, V-Notes, robot-assisted laparoscopy)
- •Patient eligible for outpatient treatment
- •Participant affiliated or beneficiary of a social security regimen
- •Participant having been informed and having given her free, informed and written consent (at the latest on the day of inclusion and before any examination required by the research)
排除标准
- •Participant with endometriosis with procedure associated with hysterectomy (digestive procedure, extended adhesiolysis, or other procedure)
- •Participant whose physical and/or psychological health is severely impaired, which according to the investigator may affect the participant's understanding and compliance with the study
- •Participant in another research
- •Participant in a period of exclusion from another research still in progress at the time of inclusion
- •Protected participant: adult under guardianship, curatorship or other legal protection, deprived of liberty by judicial or administrative decision
- •Patient hospitalized without consent
研究组 & 干预措施
Robot-assisted laparoscopy
干预措施: Benign Hysterectomy (Procedure)
Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES)
干预措施: Benign Hysterectomy (Procedure)
Conventional laparoscopy
干预措施: Benign Hysterectomy (Procedure)
结局指标
主要结局
Compare the success rate of outpatient treatment of the V-Notes route and the conventional laparoscopic route and to compare the success rate of outpatient treatment of the V-Notes route and the robot-assisted laparoscopic route.
时间窗: 6 hours post-surgery
Success rate of outpatient treatment
次要结局
- Compare the success rate he success rate of outpatient treatment of the conventional laparoscopic route and the robot-assisted laparoscopic route.(6 hours post-surgery)
- Evaluate sequelae for all surgical approaches.(3 months post-surgery)
- Evaluate post-operative pain by Digital scale.(6 hours post-surgery)
- Compare patient's quality of life.(baseline, 1 month post-surgery, 3 months post-surgery)
- Compare the recuperation of sexual function between baseline and 3 months post-surgery.(baseline, 3 months post-surgery)
- Compare the readmission rate within 7 days post-surgery for all patients.(7 days post-surgery)
- Compare patient's Hospital Anxiety and Depression Scale score during their treatment.(baseline, 1 month post-surgery, 3 months post-surgery)
- Compare intraoperative bleeding.(Day of surgery)
- Compare hemoglobin decrease during intervention.(Day of surgery)
- Compare skin-to-skin duration.(Day of surgery)
- Compare room occupancy time.(3 months post-surgery)
- Evaluate the medico-economic value of the use of each technique.(3 months post-surgery)
- Compare the readmission rate in post-operative night for all patients.(24 hours post-surgery)
- Compare patient satisfaction for all technique by 5-modal Likert scale(3 months post-surgery)
- Evaluate the reason for the failure of outpatient treatment(6 hours post-surgery)
- Compare patient satisfaction for all techniques by her opinion on: if this had to be done again (yes/no)(3 months post-surgery)
- Compare the occurence of intraoperative adverse events and up to one month postoperatively.(1 month post-surgery)
- Evaluate the use of analgesic.(8 days post-surgery)
- Compare the resumption of usual activity and work.(3 months post-surgery)