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| ID | Type | Description | Link |
|---|---|---|---|
| 2025/07-17 | Other Identifier | The Ethics Committee of Izmir Tepecik Training and Research Hospital |
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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:
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| V-NOTES | Experimental | 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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| Laparoscopy | Active Comparator | Participants in this arm will undergo bilateral tubal ligation or bilateral salpingectomy for sterilization using conventional laparoscopy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| V-NOTES Bilateral Tubal Ligation or Salpingectomy | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, postoperative 6th week, and postoperative 6th month |
| Measure | Description | Time Frame |
|---|---|---|
| Body mass index (BMI) | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Izmir Tepecik TRH | Izmir | Bornova | Turkey (Türkiye) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23389066 | Result | 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. | |
| 22442743 | Result | 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. |
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| ID | Term |
|---|---|
| D058994 | Salpingectomy |
| ID | Term |
|---|---|
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
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| Laparoscopic Bilateral Tubal Ligation or Salpingectomy | Procedure | 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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| 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. | Baseline |
| Duration of the surgical prosedure | Defined as the time in minutes from the initial incision to completion of skin closure | 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. | Intraoperative |
| Postoperative inflammatory marker - Neutrophil-to-lymphocyte ratio | Neutrophil-to-lymphocyte ratio | Preoperative and postoperative first day |
| Postoperative inflammatory marker | platelet-to-lymphocyte ratio | Preoperative and postoperative first day |
| 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 (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) | 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 |
| 28600044 | Result | 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. |
| 22922839 | Result | 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. |
| 30980993 | Result | 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. |
| 32633168 | Result | 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. |
| 10782451 | Result | 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. |
| 28186223 | Result | 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. |
| 40712463 | Result | 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. |
| 38099663 | Result | 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. |
| 38969995 | Result | 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. |
| 39686461 | Result | 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. |
| 24681063 | Result | 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. |
| 26009278 | Result | 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. |
| 22763314 | Result | 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. |
| 15229442 | Result | 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. |