Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic Approach. Prospective Study-A New Approach.
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 1
- 试验地点
- 1
- 主要终点
- Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.
研究概览
简要总结
Objective: To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization.
Study design: Prospective cohort, randomized controlled trial.
Study population: Planned Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.
Primary outcome - Adherence to planned surgical route, intra-operative parameters & complications, post-operative parameters & complications, rate of satisfaction.
详细描述
Objective
To compare the vNOTES approach versus conventional laparoscopic approach used in elective Salpingo-oophorectomy surgery for benign disease or bilateral salpingectomy for sterilization.
Study design: Prospective cohort, randomized controlled trial.
Study population: women aged over 18 who are planned to elective Salpingo-oophorectomy for benign disease or bilateral salpingectomy for sterilization.
Primary outcome - Removal of the ovaries and/or fallopian tubes according to the allocated technique, without conversion.
Secondary outcome - Duration of the surgical procedure, Duration of hospital admission (after surgery), The need for analgesics, and pain Numerical Rating Scale score , Post operation infection (up to 4 weeks from surgery), Need for medical examination/treatment or appearance of surgical complication up to 4 weeks form surgery (using Clavin Dindo Class), Bleeding assessment during surgery, Dyspareunia assessment - up to 3 months from surgery, Patient satisfaction from the surgical procedure will be measured with Patient Global Impression of Improvement (PGI-I).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women aged between 18 and 80 years.
- •women who seek for definitive surgical sterilisation.
- •women who planed for Elective bilateral salpingectomy or Salpingo-oophorectomy for a non-malignant indication
排除标准
- •history of rectal surgery.
- •rectovaginal endometriosis
- •suspected malignancy
- •History of pelvic inflammatory disease.
- •active lower genital tract infection.
- •Virgo women
- •Failure to provide written informed consent prior to surgery
结局指标
主要结局
Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.
时间窗: Intraoperative
Number of Participants With Removal of the ovaries and/or fallopian tubes according to the allocated technique.
次要结局
- Intra- Operative Complications(Intraoperative)
- Postoperative Complications(During the first six weeks after the surgical intervention)
- Duration of surgical intervention(Intraoperative)
- The use of analgetic drugs for postoperative pain(During the first week after the surgical intervention)
- Hospital Readmission(During the first six weeks after the surgical intervention)
- Patient satisfaction from the surgical procedure(At 3 months after the surgical intervention)
- Duration of hospital admission after surgical intervention(from time of admission up to time of discharge from hospital)
- Bleeding assessment during surgical intervention(Intraoperative)
- Post operation infection(detected during the first six weeks of surgery)
- Vaginal Pain During Sexual Intercourse at Three Months(At 3 months after the surgical intervention)
- Postoperative pain scores(During the first seven days after the surgical intervention)
研究者
Meirav Braverman
Principal Investigator
HaEmek Medical Center, Israel