NCT05228938

vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

Vaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic Approach. Prospective Study-A New Approach.

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 1 (actual)
• Sponsor: HaEmek Medical Center, Israel · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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).

Conditions

• Salpingectomy

Interventions

Type	Name	Description
PROCEDURE	VNOTES	vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
PROCEDURE	laparoscopic	laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy

Timeline

• Start date: 2022-05-29
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2022-02-08
• Last updated: 2024-04-02

Locations

1 site across 1 country: Israel