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.

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.

Study Overview

• Status: Terminated
• Conditions: Salpingectomy
• Intervention / Treatment: Procedure: VNOTES; Procedure: laparoscopic

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).

• Study Type: Interventional
• Enrollment (Actual): 1
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Israel
  • Afula, Israel
    • HaEmek Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Women aged between 18 and 80 years.
2. women who seek for definitive surgical sterilisation.
3. women who planed for Elective bilateral salpingectomy or Salpingo-oophorectomy for a non-malignant indication

Exclusion Criteria:

1. history of rectal surgery.
2. rectovaginal endometriosis
3. suspected malignancy
4. History of pelvic inflammatory disease.
5. active lower genital tract infection.
6. Virgo women
7. pregnancy
8. Failure to provide written informed consent prior to surgery

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Study group: vNOTES; Elective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach	Procedure: VNOTES; vaginal Natural Orifice Transluminal Endoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy
Other: Control group: Laparoscopic; Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy	Procedure: laparoscopic; laparoscopic Surgery approach for Elective bilateral salpingectomy or Salpingo-oophorectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgical intervention	(Between incision and closure) in minutes	Intraoperative
Duration of hospital admission after surgical intervention	Between surgery and time of discharge - in days	from time of admission up to time of discharge from hospital
Bleeding assessment during surgical intervention	Estimation by the major surgeon of the quantity of bleeding during surgery - in ml The amount of blood in the vacuum container in the end of the surgery	Intraoperative
Post operation infection	Postoperative infection defined by lower abdominal pain with fever > 38°C and positive clinical signs or laboratory findings, detected during the first six weeks of surgery, as a dichotomous outcome	detected during the first six weeks of surgery
Postoperative pain scores	Postoperative pain scores, measured using a Visual Analogue Scale (VAS) twice daily (morning and evening) from day 1 till 7 selfreported by the participating women. VAS scores from 0 to 10 with 0 = no pain and 10= worst pain ever imaginable.	During the first seven days after the surgical intervention
The use of analgetic drugs for postoperative pain	Postoperative pain defined by the total amount of analgesics used, as a continuous outcome.	During the first week after the surgical intervention
Intra- Operative Complications	Intra- operative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome	Intraoperative
Postoperative Complications	Postoperative complications detected during the first 6 weeks of surgery, as a dichotomous outcome	During the first six weeks after the surgical intervention
Vaginal Pain During Sexual Intercourse at Three Months	Incidence of vaginal dyspareunia recorded by the participants at 3 months by self-reporting using a simple questionnaire, as a dichotomous outcome	At 3 months after the surgical intervention
Patient satisfaction from the surgical procedure	rate of satisfacation estimated with Patient Global Impression of Improvement questionnaire (PGI-I) . (score 1-7)	At 3 months after the surgical intervention
Hospital Readmission	The number of women readmitted to hospital within six weeks following surgery, as a dichotomous outcome.	During the first six weeks after the surgical intervention

Collaborators and Investigators

• Sponsor: HaEmek Medical Center, Israel
• Investigators: Principal Investigator: meirav braverman, MD, HaEmek Medical Center; Study Director: Sivan Witzman, HaEmek Medical Center; Principal Investigator: eyal rom, MD, HaEmek Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2022
• Primary Completion (Actual): December 31, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: November 2, 2021
• First Submitted That Met QC Criteria: February 5, 2022
• First Posted (Actual): February 8, 2022

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 31, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: laparoscopic; Salpingo-oophorectomy; salpingectomy; VNOTES
• Other Study ID Numbers: 114-21

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No