CompletedNot Applicable

vNOTES in Elective Bilateral Salpingectomy for Sterilization

Turkey (Türkiye)98 participantsStarted 2021-02-12

Plain-language 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

Who can participate

Age range

18 Years – 50 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Patient satisfaction at first week

Timeframe: The first week after the surgical procedure

Patient satisfaction at first month

Timeframe: The first month after the surgical procedure

Postoperative pain at 6th hours

Timeframe: At the 6th hours after the surgical procedure

Postoperative pain at 24th hours

Timeframe: At the 24th hours after the surgical procedure

Trial details

NCT IDNCT04809428

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

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2021-05-09

View on ClinicalTrials.gov More Sterility, Female trials