跳至主要内容
临床试验/NCT04012710
NCT04012710尚未招募不适用

Transvaginal Natural Orifice Transluminal Endoscopic Surgery- A New Approach to Salpingo-oophorectomy

Sheba Medical Center2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月3日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
100
试验地点
2
主要终点
Intra - Operative complication rate

研究概览

简要总结

The aim of this study is to compare the common approach of laparoscopy for bilateral salpingo - oophorectomy to a new approach via transvaginal natural orifice transluminal endoscopic surgery (vNOTES).

详细描述

Natural Orifice Transluminal Endoscopic Surgery (NOTES) is an emerging field in minimally invasive surgery. NOTES can be performed via a variety of approaches, including through the stomach, esophagus, bladder, and rectum, but the majority of cases have been performed transvaginally (vNOTES).

The vNOTES technique includes conventional, laparoscopic instruments that are inserted through a single-port device that enables the insertion of 1 10-mm trocar, and 4 5-mm trocars. The operation in carried out placing the patient in the lithotomy position. After completing general anaesthesia, a 2.5-cm posterior colpotomy is made. The pouch of Douglas is opened and the transvaginal natural orifice transluminal endoscopic surgery (vNOTES) port is inserted transvaginally. A pneumoperitoneum is created, and the pelvic cavity, including the uterus and the adnexa is demonstrated. Only then, the conventional laparoscopic instruments are inserted.

By incorporating the advantages of endoscopic surgery, the vNOTES approach avoids abdominal wall wounds and trocar-related complications, including reducing post operation pain. Moreover, recent studies report, shorter hospital stay, improved visibility, and the possibility to circumvent extensive lysis of adhesion to reach the pelvic cavity. It should be mentioned that operative risks such as : anesthesia complications, excessive blood loss, damage to near organs ( intestines or bladder), and vasculature damage exists in both conventional laparoscopy and vNOTES approach.

vNOTES technique has been used for hysterectomy and was proven to be just as good as laparoscopy with the advantage of daycare surgery. The use of vNOTES for salpingo-oophorectomy without concomitant hysterectomy has been questioned due to challenging accessibility. To the best of our knowledge, data concerning the experience using this technique for salpingo-oophorectomy is scarce and based on few published case-reports.

Therefore, the aim of this study is to compare the common approach of laparoscopy for bilateral salpingo - oophorectomy to a new approach via transvaginal natural orifice transluminal endoscopic surgery (vNOTES).

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
None

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

入选标准

  • Elective surgery
  • Benign indication for surgery

排除标准

  • Severe endometriosis
  • Past pelvic operations
  • Suspected malignancy
  • Combined planned hysterectomy
  • Recurrent Pelvic Inflammatory disease (PID)
  • Vaginal anomaly

结局指标

主要结局

Intra - Operative complication rate

时间窗: Intra - Operative

Complications during operation as a compound outcome including - bleeding. damage to neer organs and vasculature damage

次要结局

  • Woman satisfaction rate post operation(Estimated on post operation day -1- through study completion, an average of 1 year)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Dr. Aya Mohr-Sasson

Principle Investigator

Sheba Medical Center

研究点 (2)

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相似试验

vNOTES for Salpingo-oophorectomy | 临床试验