NCT04809428

vNOTES in Elective Bilateral Salpingectomy for Sterilization

The Use of vNOTES Approach in Elective Bilateral Salpingectomy for Sterilization as a Cancer Prevention Strategy

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 98 (actual)
• Sponsor: Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

Objective: To compare the vNOTES approach versus conventional laparoscopic approach to be used in elective bilateral salpingectomy for sterilisation as an opportunistic cancer prevention strategy. Study design: Prospective cohort, two-centred trial. Study population: All women aged over 18 who are planned to undergo for definitive surgical sterilisation regardless of parity with a non-prolapsed uterus. Primary outcomes: (1) Patient satisfaction (at 1st week and 1st month of the surgery) measured by The Patient Global Imression of Improvement (PGI-I), (2) Postoperative early pain (Visual Analog Score (VAS) at 6th and 24th hours of the surgery). Secondary outcomes: (1) Conversion to laparoscopy or laparotomy, (2) duration of the procedure, (3)total amount of analgesics used, (4) New-onset dyspareunia at first coitus measured by the Pain subdomain of Female Sexual Function Index (FSFI), (5) intraoperative complications, (6) postoperative complications

Detailed description

Women who are indicated or seek for surgical sterilisation are routinely offered salpingectomy rather than tubal ligation for cancer prevention purposes as a local protocol. Those patients will be offered for vNOTES approach after detailed patient counselling and will be enrolled to the study upon acceptation.

Conditions

• Sterility, Female

Interventions

Type	Name	Description
PROCEDURE	vNOTES salpingectomy	Surgical removal of both salpinx by vNOTES with using a 3-cm of posterior colpotomy and either glove port or Gel point V path. Colpotomy will be closed with using 2.0 rapid vicryl.
PROCEDURE	Laparoscopic salpingectomy	Surgical removal of both salpinx by conventional laparoscopy in a standardised fashion: with using one 10-mm umbilical and two 5-mm lateral ports.

Timeline

• Start date: 2021-02-12
• Primary completion: 2021-05-09
• Completion: 2021-05-09
• First posted: 2021-03-22
• Last updated: 2021-06-11

Locations

2 sites across 1 country: Turkey (Türkiye)