成人慢性便秘患者腹腔镜腹侧补片直肠固定术的阶梯楔形随机试验：一项随机对照试验的研究方案
Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: study protocol for a randomized controlled trial.
作者信息
Grossi Ugo, Stevens Natasha, McAlees Eleanor, Lacy-Colson Jon, Brown Steven, Dixon Anthony, Di Tanna Gian Luca, Scott S Mark, Norton Christine, Marlin Nadine, Mason James, Knowles Charles H
机构信息
National Bowel Research Cente (NBRC) - Digestive Disease, Barts and The London School of Medicine and Dentistry, Queen Mary, University of London, 4 Newark Street, London, E1 2AT, UK.
Pragmatic Clinical Trials Unit, Blizard Institute, Queen Mary, University of London, London, UK.
出版信息
Trials. 2018 Feb 5;19(1):90. doi: 10.1186/s13063-018-2456-3.
BACKGROUND
Laparoscopic ventral mesh rectopexy (LVMR) is an established treatment for external full-thickness rectal prolapse. However, its clinical efficacy in patients with internal prolapse is uncertain due to the lack of high-quality evidence.
METHODS
An individual level, stepped-wedge randomised trial has been designed to allow observer-blinded data comparisons between patients awaiting LVMR with those who have undergone surgery. Adults with symptomatic internal rectal prolapse, unresponsive to prior conservative management, will be eligible to participate. They will be randomised to three arms with different delays before surgery (0, 12 and 24 weeks). Efficacy outcome data will be collected at equally stepped time points (12, 24, 36 and 48 weeks). The primary objective is to determine clinical efficacy of LVMR compared to controls with reduction in the Patient Assessment of Constipation Quality of Life (PAC-QOL) at 24 weeks serving as the primary outcome. Secondary objectives are to determine: (1) the clinical effectiveness of LVMR to 48 weeks to a maximum of 72 weeks; (2) pre-operative determinants of outcome; (3) relevant health economics for LVMR; (4) qualitative evaluation of patient and health professional experience of LVMR and (5) 30-day morbidity and mortality rates.
DISCUSSION
An individual-level, stepped-wedge, randomised trial serves the purpose of providing an untreated comparison for the active treatment group, while at the same time allowing the waiting-listed participants an opportunity to obtain the intervention at a later date. In keeping with the basic ethical tenets of this design, the average waiting time for LVMR (12 weeks) will be shorter than that for routine services (24 weeks).
TRIAL REGISTRATION
ISRCTN registry, ISRCTN11747152 . Registered on 30 September 2015. The trial was prospectively registered (first patient enrolled on 21 March 2016).
背景
腹腔镜腹侧补片直肠固定术（LVMR）是治疗完全性直肠外脱垂的一种成熟方法。然而，由于缺乏高质量证据，其对直肠内脱垂患者的临床疗效尚不确定。
方法
设计了一项个体水平的阶梯楔形随机试验，以便对等待LVMR治疗的患者与已接受手术的患者进行观察者盲法数据比较。有症状的直肠内脱垂且对先前保守治疗无反应的成年人有资格参与。他们将被随机分为三组，手术前有不同的延迟时间（0、12和24周）。疗效结果数据将在等间隔的时间点（12、24、36和48周）收集。主要目标是确定与对照组相比，LVMR的临床疗效，以24周时患者便秘生活质量评估（PAC-QOL）的降低作为主要结局。次要目标是确定：（1）LVMR至48周最多至72周的临床有效性；（2）结局的术前决定因素；（3）LVMR的相关卫生经济学；（4）对患者和卫生专业人员LVMR体验的定性评估；（5）30天发病率和死亡率。
讨论
个体水平的阶梯楔形随机试验旨在为积极治疗组提供未治疗的对照，同时让等待名单上的参与者有机会在以后获得干预。根据该设计的基本伦理原则，LVMR的平均等待时间（12周）将短于常规服务的等待时间（24周）。
试验注册
ISRCTN注册库，ISRCTN11747152。于2015年9月30日注册。该试验为前瞻性注册（首例患者于2016年3月21日入组）。
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