TY - JOUR
T1 - Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation
T2 - Study protocol for a randomized controlled trial
AU - Grossi, Ugo
AU - Stevens, Natasha
AU - McAlees, Eleanor
AU - Lacy-Colson, Jon
AU - Brown, Steven
AU - Dixon, Anthony
AU - Di Tanna, Gian Luca
AU - Scott, S. Mark
AU - Norton, Christine
AU - Marlin, Nadine
AU - Mason, James
AU - Knowles, Charles H.
AU - Chapman, Mark
AU - Williams, Andrew
AU - Mercer-Jones, Mark
AU - Telford, Karen
AU - Clarke, Andrew
AU - Pilkington, Sophie
AU - Yiannakou, Yan
AU - Smart, Neil
AU - Tincello, Douglas
AU - Miller, Andrew
AU - Campbell, Kenneth
AU - Cruickshank, Neil
AU - Emmett, Christopher
AU - Pares, David
AU - Horrocks, Emma
AU - Vollebregt, Paul
AU - Lindsey, Ian
AU - Jayne, David
AU - Pearce, Rupert
AU - Corrigan, Neil
AU - McLaughlin, John
AU - Gilbert, Deborah
AU - McCurrach, Ian
AU - Smalley, Louisa
AU - Emmanuel, Anton
AU - Ukoumunne, Obioha C.
AU - Al-Khafaji, Pip
AU - Bellamacina, Cynthia
AU - Davies, Glenys
AU - Webb-Wilson, Henrietta
AU - Tinkler, Linda
AU - Cairns, Liz
AU - Harding, June
AU - Stoker, Christine
AU - Burrows, Jacky
AU - Burlinson, Adele
AU - Ogden, Kate
AU - Eldridge, Sandra
AU - On behalf of the NIHR CapaCiTY working group
PY - 2018/2/5
Y1 - 2018/2/5
N2 - 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).
AB - 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).
KW - CapaCiTY
KW - CapaCiTY study 3
KW - Chronic constipation
KW - Internal rectal prolapse
KW - Laparoscopic ventral mesh rectopexy (LVMR)
KW - Rectopexy
KW - Stepped wedge
KW - Surgery
UR - http://www.scopus.com/inward/record.url?scp=85041377616&partnerID=8YFLogxK
U2 - 10.1186/s13063-018-2456-3
DO - 10.1186/s13063-018-2456-3
M3 - Article (Academic Journal)
C2 - 29402303
AN - SCOPUS:85041377616
VL - 19
JO - Trials
JF - Trials
SN - 1745-6215
M1 - 90
ER -