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Active Not Recruiting
NCT07637201
V-NOTES Versus Laparoscopy for Sterilization and Sexual Function
Conditions: Sexual Function Scores, Postoperative Recovery
Sex: Female
Ages: 30 Years – 45 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 118
Sponsor: Tepecik Training and Research Hospital
Location: Izmir Tepecik TRH Izmir Bornova
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.
Eligibility Criteria
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
Source: ClinicalTrials.gov (NCT07637201). StuddyBuddy aggregates publicly available trial information.