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ACTIVE NOT RECRUITING
NCT07637201
NA

V-NOTES Versus Laparoscopy for Sterilization and Sexual Function

Sponsor: Tepecik Training and Research Hospital

View on ClinicalTrials.gov

Summary

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.

Official title: Randomised Prospective Comparison of Sexual Function and Postoperative Recovery Following V-NOTES Versus Laparoscopic Bilateral Tubal Ligation and Salpingectomy

Key Details

Gender

FEMALE

Age Range

30 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

118

Start Date

2025-08-06

Completion Date

2026-12

Last Updated

2026-06-09

Healthy Volunteers

Yes

Interventions

PROCEDURE

V-NOTES Bilateral Tubal Ligation or Salpingectomy

Transvaginal natural orifice transluminal endoscopic surgery (V-NOTES) will be used to perform bilateral tubal ligation or bilateral salpingectomy for sterilization. In this approach, the peritoneal cavity will be accessed through a posterior vaginal fornix incision. A single-port transvaginal access platform will be inserted, and the sterilization procedure will be completed under endoscopic visualization. At the end of the procedure, the posterior vaginal fornix incision will be closed with absorbable suture.

PROCEDURE

Laparoscopic Bilateral Tubal Ligation or Salpingectomy

Laparoscopy will be used to perform bilateral tubal ligation or bilateral salpingectomy for sterilization. In this approach, the procedure will be performed through standard abdominal trocar access, including an umbilical trocar for laparoscope insertion and two additional lower abdominal trocars for surgical instruments. The sterilization procedure will be completed under laparoscopic visualization, and the abdominal skin incisions will be closed at the end of the procedure.

Locations (1)

Izmir Tepecik TRH

Izmir, Bornova, Turkey (Türkiye)