vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.
NCT05228938 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1
Last updated 2024-04-02
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.
Conditions
- Salpingectomy
Interventions
- 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
Sponsors & Collaborators
-
HaEmek Medical Center, Israel
lead OTHER
Principal Investigators
-
meirav braverman, MD · haemek medical center
-
Sivan Witzman · haemek medical center
-
eyal rom, MD · haemek medical center
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-05-29
- Primary Completion
- 2023-12-31
- Completion
- 2023-12-31
Countries
- Israel
Study Locations
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