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Assessment of Women's Sexual Quality of Life After Benign Adnexal Surgery Using vNOTES Approach

RecruitingNAAges 18 Years - 70 YearsFemaleJean Dubuisson
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In plain words

What the trial is, and whether it could suit you

Transvaginal Natural Orifice Transluminal Endoscopic Surgery (vNOTES) is a recent innovation in minimally invasive surgery which has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy in terms of efficiency and safety. However, the investigators note a lack of medical literature and no specific randomized controlled trial (RCT) assessing women's sexual function after vNOTES for benign adnexal surgery. The aim of this RCT is to confirm the non-inferiority of the vNOTES approach for benign adnexal pathology compared to CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared to CAL for benign adnexal surgery. The relationship between adnexal mass morcellation/aspiration and the quality of the histological analysis on surgical specimens will also be evaluated as seco

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Women aged from 18 to 70 years * Discernment capacity with oral and written consent signed * Heterosexual intercourse (with vaginal penetration) within four weeks prior to inclusion in the study Exclusion Criteria: * History of rectal surgery. * Suspected rectovaginal/retrocervical endometriosis. * History of brachytherapy or pelvic radiation. * Suspected malignancy. * History of severe pelvic inflammatory disease. * Active lower genital tract infection. * Pregnancy. * Women who do not speak fluent French or English. * Patients under tutelage (with or without capacity of judgement).
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What it tests

  • Elective cystectomy
  • Elective oophorectomy
  • Elective salpingectomy
  • Elective tubal sterilization
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Where

1 site
Geneva University Hospital
Geneva, Switzerland
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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