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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
118
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.
Izmir Tepecik TRH
Izmir, Bornova, Turkey (Türkiye)
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
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.