vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

NCT05228938 | Terminated

• 1 other identifier: 114-21
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

VNOTES; laparoscopic; Salpingo-oophorectomy; salpingectomy

Outcome Measures

Primary Outcomes (1)

• Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.

  Number of Participants With Removal of the ovaries and/or fallopian tubes according to the allocated technique.

  Intraoperative

Secondary Outcomes (11)

• Duration of surgical intervention

  Intraoperative

• 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

• Postoperative pain scores

  During the first seven days after the surgical intervention

Study Arms (2)

Study group: vNOTES

EXPERIMENTAL

Elective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach

Procedure: VNOTES

Control group: Laparoscopic

OTHER

Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy

Procedure: laparoscopic

Interventions

VNOTES PROCEDURE

vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy

Study group: vNOTES

laparoscopic PROCEDURE

laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy

Control group: Laparoscopic

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• history of rectal surgery.
• rectovaginal endometriosis
• suspected malignancy
• History of pelvic inflammatory disease.
• active lower genital tract infection.
• Virgo women
• pregnancy
• Failure to provide written informed consent prior to surgery

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Haemek Medical Center

Afula, Israel

Location

MeSH Terms

Interventions

Laparoscopy

Intervention Hierarchy (Ancestors)

Endoscopy; Diagnostic Techniques, Surgical; Diagnostic Techniques and Procedures; Diagnosis; Minimally Invasive Surgical Procedures; Surgical Procedures, Operative

Study Officials

• meirav braverman, MD

  haemek medical center

  PRINCIPAL INVESTIGATOR

• Sivan Witzman

  haemek medical center

  STUDY DIRECTOR

• eyal rom, MD

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: CARE PROVIDER, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 2, 2021
• First Posted: February 8, 2022
• Study Start: May 29, 2022
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: April 2, 2024

Record last verified: 2024-03

Locations

IL (1)