vNOTES in Elective Bilateral Salpingectomy for Sterilization

Sehit Prof. Dr. Ilhan Varank Sancaktepe Training and Research Hospital

Status: Completed

Conditions: Sterility, Female

Treatments: Procedure: Laparoscopic salpingectomy; Procedure: vNOTES salpingectomy

Study type: Observational

Funder types: Other

Identifiers

NCT04809428

vNOTES Salpingectomy

Details and patient eligibility

About

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

Full 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.

Enrollment: 98 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Women aged over 18 years regardless of parity with a non-prolapsed uterus
• Patients who are indicated or seek for definitive surgical sterilisation
• Patients who prefers salpingectomy over tubal ligation after considering its possible cancer prevention effect
• Written informed consent obtained prior to surgery

Exclusion criteria

• Any malignancy
• Suspected rectovaginal endometriosis
• History of pelvic inflammatory disease, pouch of Douglas abscess
• Being Virgo or Pregnant
• Failure to provide written informed consent prior to surgery

Trial design

98 participants in 2 patient groups

vNOTES Salpingectomy

Description:

Elective bilateral salpingectomy by vaginal Natural Orifice Transluminal Endoscopic Surgery approach

Treatment:

Procedure: vNOTES salpingectomy

LS Salpingectomy

Description:

Elective bilateral salpingectomy by conventional laparoscopy

Treatment:

Procedure: Laparoscopic salpingectomy