An interventional study of V-NOTES Bilateral Tubal Ligation or Salpingectomy and Laparoscopic Bilateral Tubal Ligation or Salpingectomy in Sexual Function Scores and Postoperative Recovery, sponsored by Tepecik Training and Research Hospital. Completed at 1 site in Turkey (Türkiye). Open to female participants aged 30 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-08.
Sponsored by Tepecik Training and Research Hospital · Not applicable, Interventional, and Other
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:
Participants will:
Tepecik Training and Research Hospital is the lead sponsor of 33 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm will undergo sterilization surgery, either bilateral tubal ligation or bilateral salpingectomy, using the V-NOTES approach.
Procedure: V-NOTES Bilateral Tubal Ligation or Salpingectomy
Participants in this arm will undergo bilateral tubal ligation or bilateral salpingectomy for sterilization using conventional laparoscopy.
Procedure: Laparoscopic 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.
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.
Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
The Female Sexual Function Index is a 19-item self-reported questionnaire that evaluates female sexual function across six domains: desire, arousal, lubrication, orgasm, satisfaction, and pain. The total score ranges from 2.0 to 36.0, with higher scores indicating better sexual function. The outcome will be reported as the change in total Female Sexual Function Index score from baseline to 6 weeks and 6 months after surgery. A positive change indicates improvement in sexual function, whereas a negative change indicates worsening.
Time frame: Baseline, postoperative 6th week, and postoperative 6th month
Body mass index (BMI)
Time frame: Baseline
History of previous obstetric and non-obstetric surgery
Previous surgical history will be assessed preoperatively using a structured case report form and review of the participant's medical records. Obstetric surgery includes previous cesarean section or surgery for pregnancy-related indications. Non-obstetric surgery includes previous gynecologic, abdominal, pelvic, or other surgical procedures unrelated to pregnancy. The number and percentage of participants with previous surgery will be compared between the V-NOTES and laparoscopy groups.
Time frame: Baseline/preoperative assessment
Participants With Pre-existing Comorbidities Assessed by Medical History and Medical Record Review
Pre-existing comorbidities will be assessed at baseline using participant medical history and medical record review. Comorbidities will include chronic systemic diseases such as hypertension, diabetes mellitus, cardiovascular disease, thyroid disease, pulmonary disease, and other relevant chronic conditions. The outcome will be reported as the number and percentage of participants with at least one pre-existing comorbidity in each study group.
Time frame: Baseline
Duration of the surgical prosedure
Defined as the time in minutes from the initial incision to completion of skin closure
Time frame: Intraoperative
Estimated intraoperative blood loss volume measured in milliliters
Estimated intraoperative blood loss will be assessed during surgery and recorded in milliliters (mL). Blood loss will be estimated based on the volume of blood collected in the suction canister.
Time frame: Intraoperative
Postoperative inflammatory marker - Neutrophil-to-lymphocyte ratio
Neutrophil-to-lymphocyte ratio
Time frame: Preoperative and postoperative first day
Postoperative inflammatory marker
platelet-to-lymphocyte ratio
Time frame: Preoperative and postoperative first day
Time to return to normal activity (day)
Time frame: Postoperative (up to 6 months)
Length of hospital stay (hour)
Time frame: Postoperative (up to 1 week)
Need for additional analgesic doses
Time frame: Postoperative (up to 3 days)
Complications
Intraoperative (bleeding, organ injury) Postoperative (infection, wound dehiscence, rectovaginal fistula, readmission within the first 6 weeks, dyspareunia)
Time frame: Intraoperative, postoperative (up to 6 months)
Visual analog scale (VAS)
Postoperative pain will be assessed using the Visual Analog Scale, an 11-point pain intensity scale ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain. Higher scores indicate worse postoperative pain. The mean Visual Analog Scale score will be compared between the V-NOTES and conventional laparoscopy groups.
Time frame: Postoperative 6th and 24th hour
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan
Ran from Aug 2025 to primary completion in Sep 2026, 12 months.
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Tepecik Training and Research Hospital