Baekelandt Jan Filip, De Mulder Peter A, Le Roy Ilse, Mathieu Chantal, Laenen Annouschka, Enzlin Paul, Weyers Steven, Mol Ben W J, Bosteels Jan J A
Department of Gynaecology, Imelda Hospital, Bonheiden, Belgium.
Department of Anaesthesiology, Imelda Hospital, Bonheiden, Belgium.
BMJ Open. 2018 Jan 10;8(1):e018059. doi: 10.1136/bmjopen-2017-018059.
Natural orifice transluminal endoscopic surgery (NOTES) uses natural orifices to access the cavities of the human body to perform surgical interventions. NOTES limits the magnitude of surgical trauma and potentially reduces postoperative pain. Our group published a protocol on a randomised study comparing transvaginal NOTES (vNOTES) versus laparoscopy for hysterectomy (HALON). We simultaneously designed a similar randomised controlled trial (RCT) comparing vNOTES with laparoscopy for adnexectomy. To the best of our knowledge, this is the first RCT comparing vNOTES with laparoscopy for adnexal surgery.
The methodology of the Notes Adnexectomy for Benign Indication versus Laparoscopic Excision (NOTABLE) study is similar to that of the HALON trial. Women aged 18-70 years with an indication for benign adnexal surgery will be eligible. We will use stratification according to adnexal size. Entrants will be randomised to the laparoscopic treatment (control) or vNOTES (intervention). Participants will be evaluated on days 0-7 and at 3 and 6 months. The primary outcome will be the proportion of women successfully treated by removing an adnexa by the allocated technique without conversion. We will collect the following data (secondary outcomes): proportion of women hospitalised on the day of surgery, postoperative pain scores measured two times per day from day 1 to 7, total dosage of pain killers used from day 1 to 7, hospital readmission during the first 6 weeks, dyspareunia and sexual well-being at baseline, 3 and 6 months using a validated questionnaire (Short Sexual Functioning Scale), health-related quality of life at baseline, 3 and 6 months after surgery using a validated questionnaire (EQ-5D-3L), duration of surgical intervention, infection or other surgical complications and direct costs up to 6 weeks following surgery. For the primary outcome measure, a one-sided 95% CI of the difference in the proportions of women with a successful removal of the uterus by the randomised technique will be estimated. Non-inferiority will be concluded when 15% lies above the upper limit of this 95% CI.
The study was approved on 1 December 2015 by the EthicsCommitteeof the Imelda Hospital (registration no: 689), Bonheiden, Belgium. We aim to present the final results of the NOTABLE trial in peer-reviewed journals and at scientific meetings within 4 years after the start of the recruitment.
NCT02630329.
经自然腔道内镜手术（NOTES）利用人体自然腔道进入体腔进行手术干预。NOTES限制了手术创伤程度，并有可能减轻术后疼痛。我们团队发表了一项关于比较经阴道NOTES（vNOTES）与腹腔镜子宫切除术（HALON）的随机研究方案。我们同时设计了一项类似的随机对照试验（RCT），比较vNOTES与腹腔镜附件切除术。据我们所知，这是第一项比较vNOTES与腹腔镜进行附件手术的RCT。
良性指征经自然腔道内镜附件切除术与腹腔镜切除术（NOTABLE）研究的方法与HALON试验相似。年龄在18至70岁、有良性附件手术指征的女性符合入选条件。我们将根据附件大小进行分层。入选者将被随机分配至腹腔镜治疗组（对照组）或vNOTES组（干预组）。参与者将在第0至7天以及3个月和6个月时接受评估。主要结局将是通过分配的技术成功切除附件且未中转手术的女性比例。我们将收集以下数据（次要结局）：手术当天住院的女性比例、从第1天到第7天每天测量两次的术后疼痛评分、第1天到第7天使用的止痛剂总剂量、前6周内的再次住院情况、使用经过验证的问卷（简短性功能量表）在基线、3个月和6个月时的性交困难和性健康状况、使用经过验证的问卷（EQ-5D-3L）在基线、术后3个月和6个月时的健康相关生活质量、手术干预持续时间、感染或其他手术并发症以及术后6周内的直接费用。对于主要结局指标，将估计通过随机技术成功切除子宫的女性比例差异的单侧95%置信区间。当15%高于该95%置信区间的上限时，将得出非劣效性结论。
该研究于2015年12月1日获得比利时博赫丹伊梅尔达医院伦理委员会批准（注册号：689）。我们旨在在招募开始后的4年内，在同行评审期刊和科学会议上展示NOTABLE试验的最终结果。
NCT02630329。
