The goal of this randomized clinical trial is to compare two minimally invasive surgical approaches, transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) and conventional laparoscopy, in women undergoing bilateral tubal ligation or bilateral salpingectomy for sterilization.
The main questions it aims to answer are:
* Does V-NOTES have a different effect on postoperative sexual function compared with conventional laparoscopy?
* Does V-NOTES improve postoperative recovery, including pain, discharge time, and return to normal activity?
* What surgical or medical problems occur with each surgical approach?
* Researchers will compare V-NOTES with conventional laparoscopy to see whether one approach provides better postoperative sexual function and recovery outcomes after sterilization surgery.
Participants will:
* Undergo bilateral tubal ligation or bilateral salpingectomy using either V-NOTES or conventional laparoscopy.
* Complete sexual function questionnaires before surgery, at 6 weeks after surgery, and at 6 months after surgery.
* Be evaluated for postoperative pain, discharge time, return to normal activity, need for additional pain medication, complications, and perioperative laboratory changes.
* Attend scheduled postoperative follow-up visits at 6 weeks and 6 months after surgery.
Who can participate
Age range
30 Years – 45 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 30 to 45 years
* Sexually active women
* Women who have completed childbearing and request permanent surgical sterilization
* Scheduled to undergo bilateral tubal ligation or bilateral salpingectomy for contraceptive purposes
* Able and willing to attend scheduled postoperative follow-up visits at 6 weeks and 6 months
* Able to provide written informed consent
Exclusion Criteria:
* Stage 2 or higher pelvic organ prolapse
* Active vaginal infection
* History of rectal surgery
* Suspected rectovaginal endometriosis
* Suspected malignancy
* Pregnancy
* Menopause
* Unable or unwilling to attend scheduled postoperative follow-up visits
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.
1This trial compares V-NOTES sterilization to laparoscopy — can you explain what V-NOTES actually involves and how the surgical approach differs from the laparoscopic procedure in terms of where incisions are made and how my body recovers?
2Since the trial is no longer recruiting new participants, does that affect whether I could access either of these sterilization approaches outside of the study, and which one would you recommend for my situation?
3The main thing this study is measuring is how sterilization affects sexual function using a specific scoring tool called the Female Sexual Function Index — is there existing data from standard care that already shows how laparoscopic sterilization tends to affect sexual function, so I can understand what's already known?
4Because this trial doesn't have a listed phase, it seems to be comparing two established surgical techniques rather than testing a new drug — does that mean the safety profile of both procedures is already reasonably well understood, or are there still unknowns I should be aware of?
5How would my postoperative recovery realistically compare between these two approaches based on what your clinical experience shows, and are there factors in my health history that would make one option safer or more suitable for me than the other?
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
1
Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
Timeframe: Baseline, postoperative 6th week, and postoperative 6th month