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 secondary outcome.
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
History of rectal surgery.
Suspected rectovaginal/retrocervical endometriosis.
History of brachytherapy or pelvic radiation.
Suspected malignancy.
Parallel
Elective cystectomy
Procedure/SurgeryAdnexal cyst removal for presumed benign adnexal pathology.
Elective oophorectomy
Procedure/SurgeryOvarian removal for presumed benign adnexal pathology.
Elective salpingectomy
Procedure/SurgeryTubal removal for presumed benign adnexal pathology.
Elective tubal sterilization
Procedure/SurgeryTubal obstruction as a definitive contraceptive method (tubal cauterization with or without sectioning, partial or total removal of both tubes, or obstruction with small clips/ligatures).
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Women's quality of sexual life evaluation - Female Sexual Function Index (FSFI)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Female Sexual Function Index (FSFI) questionnaire. FSFI, created in 2000 by Raymond Rosen, is a reliable and complete multidimensional self-reported instrument for the measurement of female sexual function. It is validated in English and assesses 19 items divided into six domains of sexual function: (a) desire (2 items), (b) subjective arousal (4 items), (c) lubrication (4 items), (d) orgasm (3 items), (e) satisfaction (3 items) and (f) pain/discomfort (3 items). Each item focuses on the situation during the last 4 weeks. The total score is the sum of answers provided for each of the 6 domains. Lower is the score, worse is the patient's sexual function. A total score below 26 defines impaired sexual function.
Women's quality of sexual life evaluation - Couple Satisfaction Index-16 (CSI-16)
Women's sexual Quality of Life evaluation after benigne adnexal surgery by vNOTES compared to Conventional Abdominal Laparoscopy using the Couple Satisfaction Index-16 (CSI-16) questionnaire. CSI-16 is a precise, consistent and validated scale that evaluates the quality of a couple's relationship satisfaction. Each item is scored from 0 to 5 with different answer formats. The total score can range from 0 to 81. Higher is the total score, better is the relationship satisfaction. A relationship dissatisfaction is suggested when the total score is bellow 51,5.
Effectiveness
Evaluation of the success rate (removal of the specimen without the need of conversion to laparoscopy or open-surgery) and the procedure duration including the need for adhesiolysis.
Pain evaluation
Mean pain intensity will be evaluated with the Visual Analog Scale (VAS) which rates the pain intensity from 0 for no pain to 10 being the worst pain imaginable. Pain location will be assessed in a descriptive form.
Lenght of stay
Evaluation of lenght of stay in days ranging from 0 for the day of the intervention to 30 for the 30th day after the intervention.
Pain evaluation
Pain intensity will be evaluated every day with the Visual Analog Scale (VAS) which rates the pain intensity from 0 for no pain to 10 being the worst pain imaginable. Names and classes of painkillers taken will be recorded daily during hospitalisation, noting the total milligram dosage per 24 hours for each drug (class 1 for simple analgesics, class 2 for addition of morphine derivatives, class 3 for morphine and morphine derivatives).
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Jean Dubuisson
Lead sponsor
University Hospital, Geneva
Sponsor institution
