V-NOTES Versus Laparoscopy for Sterilization and Sexual Function (VNOTES-LS-FSFI)
2026년 6월 5일 업데이트: 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.
연구 개요
상태
모집하지 않고 적극적으로
연구 유형
중재적
등록 (추정된)
118
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Bornova
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Izmir, Bornova, 터키 (Türkiye)
- Izmir Tepecik TRH
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
예
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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활성 비교기: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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체질량지수(BMI)
기간: 기준선
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기준선
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History of previous obstetric and non-obstetric surgery
기간: Baseline/preoperative assessment
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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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: Postoperative (up to 6 months)
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Postoperative (up to 6 months)
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Length of hospital stay (hour)
기간: Postoperative (up to 1 week)
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Postoperative (up to 1 week)
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Need for additional analgesic doses
기간: Postoperative (up to 3 days)
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Postoperative (up to 3 days)
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Complications
기간: 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)
기간: 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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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- 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.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2025년 8월 6일
기본 완료 (추정된)
2026년 12월 1일
연구 완료 (추정된)
2026년 12월 1일
연구 등록 날짜
최초 제출
2026년 6월 1일
QC 기준을 충족하는 최초 제출
2026년 6월 5일
처음 게시됨 (실제)
2026년 6월 9일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 9일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 5일
마지막으로 확인됨
2026년 6월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- VNOTES-LAP-STER-FSFI-2025
- 2025/07-17 (기타 식별자: The Ethics Committee of Izmir Tepecik Training and Research Hospital)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
수술 후 회복에 대한 임상 시험
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National Taiwan University Hospital초대로 등록소아과 | 폐외과 | 수술 후 빠른 회복(Enhanced Recovery After Surgery, ERAS)대만