Spots Global Cancer Trial Database for vNOTES in Elective Bilateral Salpingectomy for Sterilization

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Trial Identification

Brief Title: vNOTES in Elective Bilateral Salpingectomy for Sterilization

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

Study ID: NCT04809428

Conditions

Sterility, Female

Interventions

vNOTES salpingectomy

Laparoscopic salpingectomy

Study Description

Brief 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.