Human medicine, University of Geneva Faculty of Medicine, Geneva, Switzerland
Division of Gynecology, Department of Pediatrics, Gynecology and Obstetrics, Geneva University Hospitals, Geneva, Switzerland.
BMJ Open. 2023 Sep 7;13(9):e073691. doi: 10.1136/bmjopen-2023-073691.
Transvaginal natural orifice transluminal endoscopic surgery (vNOTES) has already proven its non-inferiority to conventional abdominal laparoscopy (CAL) for hysterectomy without conversion. The results in terms of efficacy and safety are promising. However, we note a lack of medical literature and no specific randomised controlled trial 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 with CAL on women's sexual function. Secondary outcomes will evaluate vNOTES's efficiency, morbidity and postoperative complications compared with CAL for benign adnexal surgery. The relationship between adnexal mass morcellation and the quality of the histological analysis will also be evaluated as secondary outcome.
Women aged 18-70 years undergoing a benign adnexal surgery at the Geneva University Hospitals will be eligible and randomised with a 1:1 ratio to the CAL arm or the vNOTES arm, if inclusion criteria are met. Participants will complete the Female Sexual Function Index, the Couple Satisfaction Index-16 and a self-reported questionnaire on dyspareunia within 4 weeks prior to randomisation and at 3+6 months after surgery. General and clinical data will be collected when the patient is enrolled in the study, during hospitalisation and at 1 month postoperative to assess secondary outcomes.An absence of impairment on sexual function will be confirmed with a stability or an improvement of the evaluated scores in each group at 3 and 6 months postoperative compared with the preoperative scores. We expect to have no statistically significant difference in sexuality questionnaires scores between the two groups.
Protocol of this study was validated by the Cantonal Research Ethics Commission of Geneva, Switzerland, on 9 August 2022. We aim to publish the study's results in peer-reviewed journals within 3 years.
NCT05761275.
经阴道自然腔道内镜手术（vNOTES）已被证明在不转为剖腹手术的情况下，在子宫切除术中与传统的腹腔镜（CAL）相比具有非劣效性。在疗效和安全性方面的结果很有前景。然而，我们注意到缺乏医学文献，也没有专门的随机对照试验评估良性附件手术后 vNOTES 对女性性功能的影响。本 RCT 的目的是确认 vNOTES 方法在良性附件病变方面与 CAL 相比对女性性功能的非劣效性。次要结局将评估 vNOTES 在良性附件手术中与 CAL 相比的效率、发病率和术后并发症。附件肿块粉碎与组织学分析质量之间的关系也将作为次要结局进行评估。
年龄在 18-70 岁之间，在日内瓦大学医院接受良性附件手术的妇女将符合条件并按 1:1 的比例随机分为 CAL 组或 vNOTES 组，如果符合纳入标准。参与者将在随机分组前 4 周内和手术后 3+6 个月内完成女性性功能指数、夫妇满意度指数-16 和关于性交困难的自我报告问卷。在患者入组时、住院期间和术后 1 个月收集一般和临床数据，以评估次要结局。在术后 3 和 6 个月时，与术前评分相比，每个组的评估评分保持稳定或改善，将确认性功能没有受损。我们预计两组之间在性问卷调查评分方面没有统计学上的显著差异。
本研究方案于 2022 年 8 月 9 日由瑞士日内瓦州研究伦理委员会批准。我们的目标是在 3 年内将研究结果发表在同行评议的期刊上。
NCT05761275。
