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.
調査の概要
状態
状態
完了
条件
条件
介入・治療
介入・治療
研究の種類
研究の種類
介入
入学 (実際)
入学
108
段階
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
Bornova
-
Izmir、Bornova、トルコ（Türkiye）
- Izmir Tepecik TRH
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
はい
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
アーム数
2
武器と介入
参加者グループ / アーム参加者グループ / アーム |
介入・治療介入・治療 |
|---|---|
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実験的：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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アクティブコンパレータ：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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この研究は何を測定していますか？
主要な結果の測定
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
時間枠：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
|
二次結果の測定
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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体格指数 (BMI)
時間枠：ベースライン
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ベースライン
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History of previous obstetric and non-obstetric surgery
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：Postoperative (up to 6 months)
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Postoperative (up to 6 months)
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Length of hospital stay (hour)
時間枠：Postoperative (up to 1 week)
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Postoperative (up to 1 week)
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Need for additional analgesic doses
時間枠：Postoperative (up to 3 days)
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Postoperative (up to 3 days)
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Complications
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
研究開始
2025年8月6日
一次修了 (実際)
一次修了
2026年9月3日
研究の完了 (実際)
研究の完了
2026年9月3日
試験登録日
最初に提出
最初に提出
2026年6月1日
QC基準を満たした最初の提出物
QC基準を満たした最初の提出物
2026年6月5日
最初の投稿 (実際)
最初の投稿
2026年6月9日
学習記録の更新
投稿された最後の更新 (実際)
投稿された最後の更新
2026年9月8日
QC基準を満たした最後の更新が送信されました
QC基準を満たした最後の更新が送信されました
2026年9月3日
最終確認日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
その他の研究ID番号
その他の研究ID番号
- VNOTES-LAP-STER-FSFI-2025
- 2025/07-17 (その他の識別子：The Ethics Committee of Izmir Tepecik Training and Research Hospital)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
はい
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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