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Sexual Function ScoresVNOTES-LS-FSFINCT07637201

V-NOTES Versus Laparoscopy for Sterilization and Sexual Function

A study testing V-NOTES Bilateral Tubal Ligation or Salpingectomy and Laparoscopic Bilateral Tubal Ligation or Salpingectomy in people with Sexual Function Scores and Postoperative Recovery, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 30 to 45 years, women onlyHealthy volunteers can take part
What is being tested?
V-NOTES Bilateral Tubal Ligation or Salpingectomy and Laparoscopic Bilateral Tubal Ligation or Salpingectomy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
108 participants
Where
1 siteTurkey (Türkiye)
Study dates
6 Aug 2025to 3 Sep 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 30 to 45 years
  • Women only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Turkey (Türkiye)1 site
  • Izmir Tepecik TRH

    Izmir, Bornova

Other trials in Turkey (Türkiye)

About this study

Official title: 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:

Read more
  • 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.
Being tested
V-NOTES Bilateral Tubal Ligation or Salpingectomy, Laparoscopic Bilateral Tubal Ligation or Salpingectomy
Keywords
FSFI, V-NOTES, Laparoscopy, Sterilization

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V-NOTES Bilateral Tubal Ligation or SalpingectomyProcedure or surgery

    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.

  • Laparoscopic Bilateral Tubal Ligation or SalpingectomyProcedure or surgery

    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.

Study groups in NCT07637201
Study groupRoleWhat they receive
V-NOTESExperimentalParticipants assigned to this arm will undergo sterilization surgery, either bilateral tubal ligation or bilateral salpingectomy, using the V-NOTES approach.
Receives: Procedure: V-NOTES Bilateral Tubal Ligation or Salpingectomy
LaparoscopyActive comparatorParticipants in this arm will undergo bilateral tubal ligation or bilateral salpingectomy for sterilization using conventional laparoscopy.
Receives: Procedure: Laparoscopic Bilateral Tubal Ligation or Salpingectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline, postoperative 6th week, and postoperative 6th month

Secondary outcomes (12)
  1. Body mass index (BMI)

    Measured: Baseline

  2. 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.

    Measured: Baseline/preoperative assessment

  3. 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.

    Measured: Baseline

  4. Duration of the surgical prosedure

    Defined as the time in minutes from the initial incision to completion of skin closure

    Measured: Intraoperative

  5. 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.

    Measured: Intraoperative

  6. Postoperative inflammatory marker - Neutrophil-to-lymphocyte ratio

    Neutrophil-to-lymphocyte ratio

    Measured: Preoperative and postoperative first day

  7. Postoperative inflammatory marker

    platelet-to-lymphocyte ratio

    Measured: Preoperative and postoperative first day

  8. Time to return to normal activity (day)

    Measured: Postoperative (up to 6 months)

  9. Length of hospital stay (hour)

    Measured: Postoperative (up to 1 week)

  10. Need for additional analgesic doses

    Measured: Postoperative (up to 3 days)

  11. Complications

    Intraoperative (bleeding, organ injury) Postoperative (infection, wound dehiscence, rectovaginal fistula, readmission within the first 6 weeks, dyspareunia)

    Measured: Intraoperative, postoperative (up to 6 months)

  12. 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.

    Measured: Postoperative 6th and 24th hour

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Jun 2026
  2. Study start6 Aug 2025
  3. Primary completion3 Sep 2026
  4. Study completion3 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
108 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07637201
Sponsor's protocol ID
VNOTES-LAP-STER-FSFI-2025
Other IDs
2025/07-17
Acronym
VNOTES-LS-FSFI
Status last verified
Sep 2026
First submitted
1 Jun 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • 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.

    PubMed 23389066
  • 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.

    PubMed 22442743
  • 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.

    PubMed 28600044
  • 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.

    PubMed 22922839
  • 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.

    PubMed 30980993
  • 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.

    PubMed 32633168
  • 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.

    PubMed 10782451
  • 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.

    PubMed 28186223
  • 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.

    PubMed 40712463
  • 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.

    PubMed 38099663
  • 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.

    PubMed 38969995
  • 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.

    PubMed 39686461
  • 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.

    PubMed 24681063
  • 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.

    PubMed 26009278
  • 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.

    PubMed 22763314

Questions about this trial

What is this clinical trial studying?

A study testing V-NOTES Bilateral Tubal Ligation or Salpingectomy and Laparoscopic Bilateral Tubal Ligation or Salpingectomy in people with Sexual Function Scores and Postoperative Recovery, run by Tepecik Training and Research Hospital at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in postoperative sexual function as assessed by the Female Sexual Function Index total score (time frame: Baseline, postoperative 6th week, and postoperative 6th month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07637201, which also lists 17 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026.

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