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V-NOTES Versus Laparoscopy for Sterilization and Sexual Function (VNOTES-LS-FSFI)

3 september 2026 uppdaterad av: Onur Ada, Tepecik Training and Research Hospital

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Studietyp

Interventionell

Inskrivning (Faktisk)

108

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen

Tar emot friska volontärer

Ja

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Parallellt uppdrag
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Experimentell: V-NOTES
Participants assigned to this arm will undergo sterilization surgery, either bilateral tubal ligation or bilateral salpingectomy, using the V-NOTES approach.
Procedur: 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.
Aktiv komparator: Laparoscopy
Participants in this arm will undergo bilateral tubal ligation or bilateral salpingectomy for sterilization using conventional laparoscopy.
Procedur: 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
Tidsram: 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.
Baseline, postoperative 6th week, and postoperative 6th month

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Body mass index (BMI)
Tidsram: Baslinje
Baslinje
History of previous obstetric and non-obstetric surgery
Tidsram: 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.
Baseline/preoperative assessment
Participants With Pre-existing Comorbidities Assessed by Medical History and Medical Record Review
Tidsram: 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.
Baseline
Duration of the surgical prosedure
Tidsram: Intraoperative
Defined as the time in minutes from the initial incision to completion of skin closure
Intraoperative
Estimated intraoperative blood loss volume measured in milliliters
Tidsram: 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.
Intraoperative
Postoperative inflammatory marker - Neutrophil-to-lymphocyte ratio
Tidsram: Preoperative and postoperative first day
Neutrophil-to-lymphocyte ratio
Preoperative and postoperative first day
Postoperative inflammatory marker
Tidsram: Preoperative and postoperative first day
platelet-to-lymphocyte ratio
Preoperative and postoperative first day
Time to return to normal activity (day)
Tidsram: Postoperative (up to 6 months)
Postoperative (up to 6 months)
Length of hospital stay (hour)
Tidsram: Postoperative (up to 1 week)
Postoperative (up to 1 week)
Need for additional analgesic doses
Tidsram: Postoperative (up to 3 days)
Postoperative (up to 3 days)
Complications
Tidsram: Intraoperative, postoperative (up to 6 months)
Intraoperative (bleeding, organ injury) Postoperative (infection, wound dehiscence, rectovaginal fistula, readmission within the first 6 weeks, dyspareunia)
Intraoperative, postoperative (up to 6 months)
Visual analog scale (VAS)
Tidsram: 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.
Postoperative 6th and 24th hour

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Tepecik Training and Research Hospital

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Allmänna publikationer

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

6 augusti 2025

Primärt slutförande (Faktisk)

3 september 2026

Avslutad studie (Faktisk)

3 september 2026

Studieregistreringsdatum

Först inskickad

1 juni 2026

Först inskickad som uppfyllde QC-kriterierna

5 juni 2026

Första postat (Faktisk)

9 juni 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

8 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • VNOTES-LAP-STER-FSFI-2025
  • 2025/07-17 (Annan identifierare: The Ethics Committee of Izmir Tepecik Training and Research Hospital)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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