Department of Obstetrics and Gynaecology, PEDEGO Research Unit and Medical Research Center Oulu, Oulu University Hospital, University of Oulu, Oulu, Finland
Department of Surgery, Research Unit of Surgery, Anesthesia and Intensive Care, Oulu University Hospital, University of Oulu, Oulu, Finland.
BMJ Open. 2022 Jul 18;12(7):e063572. doi: 10.1136/bmjopen-2022-063572.
Endometriosis is a common gynaecological disease affecting around 10% of fertile-aged women, causing severe pain symptoms. Deep endometriosis is defined as endometriotic implants that infiltrate the underlying organs more than 5 mm in depth. Surgery for deep endometriosis requires advanced multidisciplinary surgical technique, often in very difficult surgical conditions, with increased risks of complications. Robotic surgery offers a high-definition three-dimensional view and articulating instruments that may allow more precise dissection than conventional laparoscopy in the pelvic area. The superiority of robotic surgery has not, however, been provedin randomised controlled studies, and there is a lack of long-term outcome data. Advanced endometriosis surgery offers an excellent platform to study the feasibility and long-term outcomes of robotic surgery compared with conventional laparoscopy.
ROBEndo is a prospective, randomised, controlled clinical trial in a single-centre setting. Patients with deep endometriosis verified by MRI needing surgery at Oulu University Hospital (Oulu, Finland) will be considered eligible. 70 patients will be allocated 1:1 to receive either robotic-assisted or conventional laparoscopic surgery in two strata: radical surgery (with the removal of the uterus and adnexae) and gynaecological organ-sparing surgery. The primary outcome will be the surgical outcome as regards to pain symptoms measured on numeric rating scale (NRS) questionnaires at 24 hours and 6, 12 and 24 months postoperatively. As secondary outcomes, intraoperative measures, enhanced recovery after surgery factors, complications, cost and long-term quality of life measured with Endometriosis Health Profile-30 (EHP-30), Female Sexual Function Index (FSFI) and 15-dimensional (15D) questionnaires will be compared.
This study has been approved by the Northern Ostrobothnian Hospital District Ethical Committee at Oulu University Hospital (212/2021). Informed consent will be obtained during the preoperative check-up by the operating gynaecologist. The results will be published in peer-reviewed international journals.
NCT05179109.
子宫内膜异位症是一种常见的妇科疾病，影响约 10%的育龄妇女，导致严重的疼痛症状。深部子宫内膜异位症定义为子宫内膜异位症病灶浸润深度超过 5 毫米的深部器官。深部子宫内膜异位症的手术需要先进的多学科手术技术，通常在非常困难的手术条件下进行，并发症风险增加。机器人手术提供了高清三维视图和铰接器械，这可能比传统腹腔镜在盆腔区域提供更精确的解剖。然而，机器人手术的优势尚未在随机对照研究中得到证实，并且缺乏长期结果数据。高级子宫内膜异位症手术为研究机器人手术与传统腹腔镜手术的可行性和长期结果提供了极好的平台。
ROBEndo 是一项在单一中心进行的前瞻性、随机、对照临床试验。需要在奥卢大学医院（芬兰奥卢）进行手术的经 MRI 证实的深部子宫内膜异位症患者将被视为符合条件。70 名患者将按照 1:1 的比例分配，接受机器人辅助或传统腹腔镜手术，分为两个层次：根治性手术（子宫和附件切除）和妇科器官保留手术。主要结果将是手术后 24 小时和 6、12 和 24 个月时数字评定量表（NRS）问卷测量的疼痛症状的手术结果。次要结果将比较术中措施、术后快速康复因素、并发症、成本和长期生活质量，使用子宫内膜异位症健康状况问卷-30（EHP-30）、女性性功能指数（FSFI）和 15 维（15D）问卷进行评估。
本研究已获得奥卢大学医院北奥斯特罗波西亚医院区伦理委员会的批准（212/2021）。手术妇科医生将在术前检查期间获得知情同意。结果将发表在同行评议的国际期刊上。
NCT05179109。
