Postoperative Recovery, Sexual Function Scores
Conditions
Keywords
FSFI, V-NOTES, Laparoscopy, Sterilization
Brief 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.
Interventions
PROCEDUREV-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.
PROCEDURELaparoscopic 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.
Sponsors
Tepecik Training and Research Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in postoperative sexual function as assessed by the Female Sexual Function Index total score | Baseline, postoperative 6th week, and postoperative 6th month | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Body mass index (BMI) | Baseline | — |
| History of previous obstetric and non-obstetric surgery | Baseline/preoperative assessment | 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. |
| Participants With Pre-existing Comorbidities Assessed by Medical History and Medical Record Review | Baseline | 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. |
| Duration of the surgical prosedure | Intraoperative | Defined as the time in minutes from the initial incision to completion of skin closure |
| Estimated intraoperative blood loss volume measured in milliliters | Intraoperative | 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. |
| Postoperative inflammatory marker - Neutrophil-to-lymphocyte ratio | Preoperative and postoperative first day | Neutrophil-to-lymphocyte ratio |
| Postoperative inflammatory marker | Preoperative and postoperative first day | platelet-to-lymphocyte ratio |
| Time to return to normal activity (day) | Postoperative (up to 6 months) | — |
| Length of hospital stay (hour) | Postoperative (up to 1 week) | — |
| Need for additional analgesic doses | Postoperative (up to 3 days) | — |
| Complications | Intraoperative, postoperative (up to 6 months) | Intraoperative (bleeding, organ injury) Postoperative (infection, wound dehiscence, rectovaginal fistula, readmission within the first 6 weeks, dyspareunia) |
| Visual analog scale (VAS) | Postoperative 6th and 24th hour | 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. |
Countries
Turkey (Türkiye)
Outcome results
None listed