vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

Not Applicable

Terminated

• Conditions: Salpingectomy
• Interventions: Procedure: laparoscopic; Procedure: VNOTES

• Registration Number: NCT05228938
• Lead Sponsor: HaEmek Medical Center, Israel

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.

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 Timeline

• Study First Submitted: 2021-11-02
• Study First Submitted QC: 2022-02-05
• Study First Posted: 2022-02-08
• Study Start: 2022-05-29
• Primary Completion: 2023-12-31
• Study Completion: 2023-12-31
• Status Verified: 2024-03
• Last Update Submitted: 2024-03-31
• Last Update Posted: 2024-04-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group: Laparoscopic	laparoscopic	Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy
Study group: vNOTES	VNOTES	Elective bilateral salpingectomy or Salpingo-oophorectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach

Primary Outcome Measures

Name	Time	Method
Successful removal of the fallopian tubes or adnexa without a need to convert to another technique.	Intraoperative	Number of Participants With Removal of the ovaries and/or fallopian tubes according to the allocated technique.

Secondary Outcome Measures

Name	Time	Method
Intra- Operative Complications	Intraoperative	Intra- operative complications according to the Clavien- Dindo classification detected during the first six weeks of surgery, as a dichotomous outcome
Postoperative Complications	During the first six weeks after the surgical intervention	Postoperative complications detected during the first 6 weeks of surgery, as a dichotomous outcome
Duration of surgical intervention	Intraoperative	(Between incision and closure) in minutes
The use of analgetic drugs for postoperative pain	During the first week after the surgical intervention	Postoperative pain defined by the total amount of analgesics used, as a continuous outcome.
Hospital Readmission	During the first six weeks after the surgical intervention	The number of women readmitted to hospital within six weeks following surgery, as a dichotomous outcome.
Patient satisfaction from the surgical procedure	At 3 months after the surgical intervention	rate of satisfacation estimated with Patient Global Impression of Improvement questionnaire (PGI-I) . (score 1-7)
Duration of hospital admission after surgical intervention	from time of admission up to time of discharge from hospital	Between surgery and time of discharge - in days
Bleeding assessment during surgical intervention	Intraoperative	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
Post operation infection	detected during the first six weeks of surgery	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
Vaginal Pain During Sexual Intercourse at Three Months	At 3 months after the surgical intervention	Incidence of vaginal dyspareunia recorded by the participants at 3 months by self-reporting using a simple questionnaire, as a dichotomous outcome
Postoperative pain scores	During the first seven days after the surgical intervention	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.

Trial Locations

Locations (1)

Haemek Medical Center; 🇮🇱 Afula, Israel