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

Autor:	Grossi, U., Stevens, N., Mcalees, E., Lacy-Colson, J., Brown, S., Dixon, A., Di Tanna, G. L., Scott, S. M., Norton, C., Marlin, N., Mason, J., Knowles, C. H., Chapman, M., Williams, A., Mercer-Jones, M., Telford, K., Clarke, A., Pilkington, S., Yiannakou, Y., Smart, N., Tincello, D., Miller, A., Campbell, K., Cruickshank, N., Emmett, C., Pares, D., Horrocks, E., Vollebregt, P., Lindsey, I., Jayne, D., Pearce, R., Corrigan, N., Mclaughlin, J., Gilbert, D., Mccurrach, I., Smalley, L., Emmanuel, A., Ukoumunne, O. C., Al-Khafaji, P., Bellamacina, C., Davies, G., Webb-Wilson, H., Tinkler, L., Cairns, L., Harding, J., Stoker, C., Burrows, J., Burlinson, A., Ogden, K., Savage, I., Giordano, P., Siddiqi, S., Hance, J., Praveen, B. V. R., Nisar, P., Collie, M., Eldridge, S., Waring, M., Michael, K., Hansen, J., Manivannan, A., Uddin, N., Vaizey, C., Taylor, S., Moss-Morris, R.
Rok vydání:	2018
Předmět:	Male Time Factors Constipation CapaCiTY CapaCiTY study 3 Chronic constipation Internal rectal prolapse Laparoscopic ventral mesh rectopexy (LVMR) Rectopexy Stepped wedge Surgery Adolescent Adult Aged Chronic Disease Digestive System Surgical Procedures Female Humans Laparoscopy Middle Aged Multicenter Studies as Topic Quality of Life Randomized Controlled Trials as Topic Recovery of Function Rectal Prolapse Rectum Treatment Outcome United Kingdom Young Adult Defecation Surgical Mesh Medicine (miscellaneous) law.invention Study Protocol 0302 clinical medicine Randomized controlled trial Quality of life law Medicine Pharmacology (medical) lcsh:R5-920 medicine.diagnostic_test 030220 oncology & carcinogenesis 030211 gastroenterology & hepatology medicine.symptom lcsh:Medicine (General) medicine.medical_specialty 03 medical and health sciences Journal Article business.industry medicine.disease Rectal prolapse Surgical mesh Physical therapy business
Zdroj:	Grossi, U, Stevens, N, McAlees, E, Lacy-Colson, J, Brown, S, Dixon, A, Di Tanna, G L, Scott, S M, Norton, C, Marlin, N, Mason, J, Knowles, C H 2018, ' Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation : Study protocol for a randomized controlled trial ', Trials, vol. 19, 90 . https://doi.org/10.1186/s13063-018-2456-3 Trials TRIALS Grossi, U, Stevens, N, McAlees, E, Lacy-Colson, J, Brown, S, Dixon, A, Di Tanna, G L, Scott, S M, Norton, C, Marlin, N, Mason, J, Knowles, C H 2018, ' Stepped-wedge randomised trial of laparoscopic ventral mesh rectopexy in adults with chronic constipation : study protocol for a randomized controlled trial ', Trials, vol. 19, 90 . https://doi.org/10.1186/s13063-018-2456-3 Trials, Vol 19, Iss 1, Pp 1-19 (2018)
ISSN:	1745-6215
DOI:	10.1186/s13063-018-2456-3
Popis:	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). Electronic supplementary material The online version of this article (10.1186/s13063-018-2456-3) contains supplementary material, which is available to authorized users.
Databáze:	OpenAIRE
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