V-NOTES Versus Laparoscopy for Sterilization and Sexual Function (VNOTES-LS-FSFI)
2026年9月3日 更新者：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.
研究概览
地位
完全的
研究类型
介入性
注册 (实际的)
108
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Bornova
-
Izmir、Bornova、土耳其（türkiye）
- Izmir Tepecik TRH
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-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
接受健康志愿者
是的
描述
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
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：其他
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：V-NOTES
Participants assigned to this arm will undergo sterilization surgery, either bilateral tubal ligation or bilateral salpingectomy, using the V-NOTES approach.
|
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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有源比较器：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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
大体时间：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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
体重指数 (BMI)
大体时间：基线
|
基线
|
|
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History of previous obstetric and non-obstetric surgery
大体时间：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
大体时间：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.
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Baseline
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Duration of the surgical prosedure
大体时间：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
大体时间：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
大体时间：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
大体时间：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)
大体时间：Postoperative (up to 6 months)
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Postoperative (up to 6 months)
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Length of hospital stay (hour)
大体时间：Postoperative (up to 1 week)
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Postoperative (up to 1 week)
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Need for additional analgesic doses
大体时间：Postoperative (up to 3 days)
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Postoperative (up to 3 days)
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Complications
大体时间：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)
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2025年8月6日
初级完成 (实际的)
2026年9月3日
研究完成 (实际的)
2026年9月3日
研究注册日期
首次提交
2026年6月1日
首先提交符合 QC 标准的
2026年6月5日
首次发布 (实际的)
2026年6月9日
研究记录更新
最后更新发布 (实际的)
2026年9月8日
上次提交的符合 QC 标准的更新
2026年9月3日
最后验证
2026年9月1日
更多信息
与本研究相关的术语
其他研究编号
- VNOTES-LAP-STER-FSFI-2025
- 2025/07-17 (其他标识符：The Ethics Committee of Izmir Tepecik Training and Research Hospital)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 共享支持信息类型
- 研究方案
- 树液
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.