Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation: study protocol for a randomized controlled trial

Abstract

BackgroundLaparoscopic 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.MethodsAn 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.DiscussionAn 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 registrationISRCTN registry, ISRCTN11747152. Registered on 30 September 2015. The trial was prospectively registered (first patient enrolled on 21 March 2016).Electronic supplementary materialThe online version of this article (10.1186/s13063-018-2456-3) contains supplementary material, which is available to authorized users.

Stepped-wedge randomized controlled trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation

“…LVMR was performed according to a standard technique [ 31 , 37 , 38 ], starting with a peritoneal incision at the level of the sacral promontory and extending caudally (avoiding the hypogastric nerves along the side of the mesorectum) to the deepest part of the pouch of Douglas, and continued down the rectovaginal septum to the pelvic floor. The mesh was sutured to the ventral aspect of the distal rectum and further fixed to the lateral seromuscular borders of the rectum proximal and distal to the incised pouch of Douglas ± pelvic floor.…”

“…Adherence to the agreed procedural technique for the first included patient from each center was independently remotely assessed by a delegated surgical team provided by the Pelvic Floor Section of the Association of Coloproctology of Great Britain and Ireland. Monitoring and quality control were conducted remotely via video submission and assessed against the standardized LVMR protocol and defined assessment criteria [ 31 , 37 , 38 ]. Monitoring took the form of planned, random and triggered sessions (Supplementary Table 1).…”

Optimal allocation to treatment sequences in individually randomized stepped-wedge designs with attrition

“…Of course, it is also possible to implement the stepped-wedge design in an individually randomized trial. 6 Examples are trials to treat obstructive sleep apnoea, 7 chronic constipation, 8 malformations, 9 , 10 dementia, 11 to reduce household air pollution 12 and to evaluate self-management support programmes 13 and spillover of HIV knowledge. 14 The design of the individually randomized stepped-wedge design has not yet been thoroughly explored in the statistical literature.…”