V-NOTES Versus Laparoscopy for Sterilization and Sexual Function (VNOTES-LS-FSFI)
5 de junho de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ativo, não recrutando
Tipo de estudo
Intervencional
Inscrição (Estimado)
118
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Bornova
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Izmir, Bornova, Turquia (Türkiye)
- Izmir Tepecik TRH
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Sim
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: 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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Comparador Ativo: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in postoperative sexual function as assessed by the Female Sexual Function Index total score
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Índice de massa corporal (IMC)
Prazo: Linha de base
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Linha de base
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History of previous obstetric and non-obstetric surgery
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)
Prazo: Postoperative (up to 6 months)
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Postoperative (up to 6 months)
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Length of hospital stay (hour)
Prazo: Postoperative (up to 1 week)
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Postoperative (up to 1 week)
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Need for additional analgesic doses
Prazo: Postoperative (up to 3 days)
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Postoperative (up to 3 days)
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Complications
Prazo: 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)
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
6 de agosto de 2025
Conclusão Primária (Estimado)
1 de dezembro de 2026
Conclusão do estudo (Estimado)
1 de dezembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
5 de junho de 2026
Primeira postagem (Real)
9 de junho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de junho de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
5 de junho de 2026
Última verificação
1 de junho de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- VNOTES-LAP-STER-FSFI-2025
- 2025/07-17 (Outro identificador: The Ethics Committee of Izmir Tepecik Training and Research Hospital)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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