V-NOTES Versus Laparoscopy for Sterilization and Sexual Function (VNOTES-LS-FSFI)
3. september 2026 oppdatert 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.
Studieoversikt
Status
Fullført
Studietype
Intervensjonell
Registrering (Faktiske)
108
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Bornova
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Izmir, Bornova, Tyrkia (Türkiye)
- Izmir Tepecik TRH
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Ja
Beskrivelse
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Annen
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: V-NOTES
Participants assigned to this arm will undergo sterilization surgery, either bilateral tubal ligation or bilateral salpingectomy, using the V-NOTES approach.
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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.
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Aktiv komparator: Laparoscopy
Participants in this arm will undergo bilateral tubal ligation or bilateral salpingectomy for sterilization using conventional laparoscopy.
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
Tidsramme: Baseline, postoperative 6th week, and postoperative 6th month
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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.
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Baseline, postoperative 6th week, and postoperative 6th month
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Kroppsmasseindeks (BMI)
Tidsramme: Grunnlinje
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Grunnlinje
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History of previous obstetric and non-obstetric surgery
Tidsramme: 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.
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Baseline/preoperative assessment
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Participants With Pre-existing Comorbidities Assessed by Medical History and Medical Record Review
Tidsramme: Baseline
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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.
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Baseline
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Duration of the surgical prosedure
Tidsramme: Intraoperative
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Defined as the time in minutes from the initial incision to completion of skin closure
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Intraoperative
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Estimated intraoperative blood loss volume measured in milliliters
Tidsramme: Intraoperative
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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.
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Intraoperative
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Postoperative inflammatory marker - Neutrophil-to-lymphocyte ratio
Tidsramme: Preoperative and postoperative first day
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Neutrophil-to-lymphocyte ratio
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Preoperative and postoperative first day
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Postoperative inflammatory marker
Tidsramme: Preoperative and postoperative first day
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platelet-to-lymphocyte ratio
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Preoperative and postoperative first day
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Time to return to normal activity (day)
Tidsramme: Postoperative (up to 6 months)
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Postoperative (up to 6 months)
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Length of hospital stay (hour)
Tidsramme: Postoperative (up to 1 week)
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Postoperative (up to 1 week)
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Need for additional analgesic doses
Tidsramme: Postoperative (up to 3 days)
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Postoperative (up to 3 days)
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Complications
Tidsramme: Intraoperative, postoperative (up to 6 months)
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Intraoperative (bleeding, organ injury) Postoperative (infection, wound dehiscence, rectovaginal fistula, readmission within the first 6 weeks, dyspareunia)
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Intraoperative, postoperative (up to 6 months)
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Visual analog scale (VAS)
Tidsramme: Postoperative 6th and 24th hour
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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.
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Postoperative 6th and 24th hour
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.
- Lee CL, Wu KY, Su H, Wu PJ, Han CM, Yen CF. Hysterectomy by transvaginal natural orifice transluminal endoscopic surgery (NOTES): a series of 137 patients. J Minim Invasive Gynecol. 2014 Sep-Oct;21(5):818-24. doi: 10.1016/j.jmig.2014.03.011. Epub 2014 Mar 25.
- Baekelandt J. Total Vaginal NOTES Hysterectomy: A New Approach to Hysterectomy. J Minim Invasive Gynecol. 2015 Sep-Oct;22(6):1088-94. doi: 10.1016/j.jmig.2015.05.015. Epub 2015 May 22.
- Coomber RS, Sodergren MH, Clark J, Teare J, Yang GZ, Darzi A. Natural orifice translumenal endoscopic surgery applications in clinical practice. World J Gastrointest Endosc. 2012 Mar 16;4(3):65-74. doi: 10.4253/wjge.v4.i3.65.
- Ahn KH, Song JY, Kim SH, Lee KW, Kim T. Transvaginal single-port natural orifice transluminal endoscopic surgery for benign uterine adnexal pathologies. J Minim Invasive Gynecol. 2012 Sep-Oct;19(5):631-5. doi: 10.1016/j.jmig.2012.04.001. Epub 2012 Jul 3.
- Myles PS, Myles DB, Galagher W, Boyd D, Chew C, MacDonald N, Dennis A. Measuring acute postoperative pain using the visual analog scale: the minimal clinically important difference and patient acceptable symptom state. Br J Anaesth. 2017 Mar 1;118(3):424-429. doi: 10.1093/bja/aew466.
- Tanaka M, Sagawa T, Yamazaki R, Myojo S, Dohi S, Inoue M. Evaluation of transvaginal peritoneal surgery in young female patients. Surg Endosc. 2013 Jul;27(7):2619-24. doi: 10.1007/s00464-012-2749-7. Epub 2013 Feb 7.
- Li YC, Ku FC, Kuo HH, Tseng HJ, Wang CJ. Transvaginal endoscopic surgery-assisted versus conventional laparoscopic adnexectomy (TVEA vs. CLA): A propensity-matched study and literature review. Taiwan J Obstet Gynecol. 2017 Jun;56(3):336-341. doi: 10.1016/j.tjog.2017.04.013.
- Linke GR, Luz S, Janczak J, Zerz A, Schmied BM, Siercks I, Warschkow R, Beutner U, Tarantino I. Evaluation of sexual function in sexually active women 1 year after transvaginal NOTES: a prospective cohort study of 106 patients. Langenbecks Arch Surg. 2013 Jan;398(1):139-45. doi: 10.1007/s00423-012-0993-x. Epub 2012 Aug 26.
- Huang YT, Yang LY, Pan YB, Huang HY, Wu KY, Wang CJ, Weng CH. Learning Curve Analysis of Transvaginal Natural Orifice Adnexal Surgery. J Minim Invasive Gynecol. 2020 Feb;27(2):489-497. doi: 10.1016/j.jmig.2019.04.009. Epub 2019 Apr 10.
- Kaya C, Alay I, Cengiz H, Baghaki S, Aslan O, Ekin M, Yasar L. Conventional Laparoscopy or Vaginally Assisted Natural Orifice Transluminal Endoscopic Surgery for Adnexal Pathologies: A Paired Sample Cross-Sectional Study. J Invest Surg. 2021 Nov;34(11):1185-1190. doi: 10.1080/08941939.2020.1789246. Epub 2020 Jul 7.
- Kaya C, Aktoz F, Gunes AC, Tercan C, Sacinti KG, Yassa M, AlAli H. Evaluating the efficacy and benefits of vNOTES for ovarian cystectomy: a systematic review and meta-analysis. Eur J Obstet Gynecol Reprod Biol. 2025 Sep;313:114596. doi: 10.1016/j.ejogrb.2025.114596. Epub 2025 Jul 22.
- Zhang Y, Jia Y, Dai X, Wang F, Gong Y. Transvaginal natural orifice transluminal endoscopic surgery-assisted versus transumbilical laparoendoscopic single-site ovarian cystectomy for ovarian mature cystic teratoma. A randomized controlled trial. Ginekol Pol. 2024;95(5):343-349. doi: 10.5603/gpl.95422. Epub 2023 Dec 15.
- Yan J, Zhou D, Zhang S, Zhang B, Tuo X, Meng Q, Lv Q. Clinical efficacy and safety of transvaginal natural orifice transluminal endoscopic surgery for benign adnexal disease: a prospective trial. BMC Womens Health. 2024 Jul 5;24(1):390. doi: 10.1186/s12905-024-03226-5.
- Mollahuseyinoglu Kullac F, Ozdemir AZ, Yildiz C. A single center retrospective study of vNOTES hysterectomy, laparoscopic hysterectomy and vaginal hysterectomy operations. Medicine (Baltimore). 2024 Dec 13;103(50):e40881. doi: 10.1097/MD.0000000000040881.
- Kalloo AN, Singh VK, Jagannath SB, Niiyama H, Hill SL, Vaughn CA, Magee CA, Kantsevoy SV. Flexible transgastric peritoneoscopy: a novel approach to diagnostic and therapeutic interventions in the peritoneal cavity. Gastrointest Endosc. 2004 Jul;60(1):114-7. doi: 10.1016/s0016-5107(04)01309-4.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
6. august 2025
Primær fullføring (Faktiske)
3. september 2026
Studiet fullført (Faktiske)
3. september 2026
Datoer for studieregistrering
Først innsendt
1. juni 2026
Først innsendt som oppfylte QC-kriteriene
5. juni 2026
Først lagt ut (Faktiske)
9. juni 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
8. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
3. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- VNOTES-LAP-STER-FSFI-2025
- 2025/07-17 (Annen identifikator: The Ethics Committee of Izmir Tepecik Training and Research Hospital)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
JA
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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