vNOTES Salpingo-oophorectomy or Bilateral Salpingectomy Compared With Laparoscopic.

HaEmek Medical Center, Israel

Status: Terminated

Conditions: Salpingectomy

Treatments: Procedure: VNOTES; Procedure: laparoscopic

Study type: Interventional

Funder types: Other

Identifiers

NCT05228938

114-21

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1 patient

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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1 participants in 2 patient groups

Study group: vNOTES

Experimental group

Description:

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

Treatment:

Procedure: VNOTES

Control group: Laparoscopic

Other group

Description:

Elective bilateral salpingectomy or Salpingo-oophorectomy by conventional laparoscopy

Treatment:

Procedure: laparoscopic