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Published in: Trials 1/2017

Open Access 01-12-2017 | Study protocol

Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial

Published in: Trials | Issue 1/2017

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Abstract

Background

Constipation is common in adults and up to 20% of the population report this symptom. Chronic constipation (CC), usually defined as more than 6 months of symptoms, is less common but results in 0.5 million UK GP consultations per annum. The effect of symptoms on measured quality of life (QOL) is significant, and CC consumes significant health care resources. In the UK, it is estimated that 10% of district nursing time is spent on constipation. Trans-anal irrigation therapy has become a widely used treatment despite a lack of robust efficacy data to support its use. The long-term outcome of treatment is also unclear. A randomised comparison of two different methods of irrigation (high- and low-volume) will provide valuable evidence of superiority of one system over the other, as well as providing efficacy data for the treatment as a whole.

Methods

Participants will be recruited based on predetermined eligibility criteria. Following informed consent, they will be randomised to either high-volume (HV) or low-volume (LV) irrigation and undergo standardised radiological and physiological investigations. Following training, they will commence home irrigation with the allocated device. Data will be collected at 1, 3, 6 and 12 months according to a standardised outcomes framework. The primary outcome is PAC-QOL, measured at 3 months. The study is powered to detect a 10% difference in outcome between systems at 3 months; this means that 300 patients will need to be recruited.

Discussion

This study will be the first randomised comparison of two different methods of trans-anal irrigation. It will also be the largest prospective study of CC patients treated with irrigation. It will provide evidence for the effectiveness of irrigation in the treatment of CC, as well as the comparative effectiveness of the two methods. This will enable more cost-effective and evidence-based use of irrigation. Also, the results will be combined with the other studies in the CapaCiTY programme to generate an evidence-based treatment algorithm for CC in adults.

Trial registration

ISRCTN, identifier: ISRCTN11093872. Registered on 11 November 2015. Trial not retrospectively registered. Protocol version 3 (22 January 2016).
Appendix
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Literature
1.
Sonnenberg A, Koch TR. Epidemiology of constipation in the United States. Dis Colon Rectum. 1989;32(1):1–8.CrossRefPubMed
2.
Stewart WF, Liberman JN, Sandler RS, Woods MS, Stemhagen A, Chee E, et al. Epidemiology of constipation (EPOC) study in the United States: relation of clinical subtypes to sociodemographic features. Am J Gastroenterol. 1999;94(12):3530–40.CrossRefPubMed
3.
van den Berg MM, Benninga MA, Di Lorenzo C. Epidemiology of childhood constipation: a systematic review. Am J Gastroenterol. 2006;101(10):2401–9.CrossRefPubMed
4.
McCrea GL, Miaskowski C, Stotts NA, Macera L, Paul SM, Varma MG. Gender differences in self-reported constipation characteristics, symptoms, and bowel and dietary habits among patients attending a specialty clinic for constipation. Gend Med. 2009;6(1):259–71.CrossRefPubMed
5.
Mugie SM, Benninga MA, Di Lorenzo C. Epidemiology of constipation in children and adults: a systematic review. Best Pract Res Clin Gastroenterol. 2011;25(1):3–18.CrossRefPubMed
6.
Norton C. Constipation in older patients: effects on quality of life. Br J Nurs. 2006;15(4):188–92.CrossRefPubMed
7.
Gallegos-Orozco JF, Foxx-Orenstein AE, Sterler SM, Stoa JM. Chronic constipation in the elderly. Am J Gastroenterol. 2012;107(1):18–25. quiz 26.CrossRefPubMed
8.
Probert CS, Emmett PM, Heaton KW. Some determinants of whole-gut transit time: a population-based study. QJM. 1995;88(5):311–5.PubMed
9.
Cook IJ, Talley NJ, Benninga MA, Rao SS, Scott SM. Chronic constipation: overview and challenges. Neurogastroenterol Motil. 2009;21 Suppl 2:1–8.CrossRefPubMed
10.
Knowles CH, Scott SM, Rayner C, Glia A, Lindberg G, Kamm MA, et al. Idiopathic slow-transit constipation: an almost exclusively female disorder. Dis Colon Rectum. 2003;46(12):1716–7.CrossRefPubMed
11.
Wald A, Scarpignato C, Mueller-Lissner S, Kamm MA, Hinkel U, Helfrich I, et al. A multinational survey of prevalence and patterns of laxative use among adults with self-defined constipation. Aliment Pharmacol Ther. 2008;28(7):917–30.PubMed
12.
Irvine EJ, Ferrazzi S, Pare P, Thompson WG, Rance L. Health-related quality of life in functional GI disorders: focus on constipation and resource utilization. Am J Gastroenterol. 2002;97(8):1986–93.CrossRefPubMed
13.
Peery AF, Dellon ES, Lund J, Crockett SD, McGowan CE, Bulsiewicz WJ, et al. Burden of gastrointestinal disease in the United States: 2012 update. Gastroenterology. 2012;143(5):1179–87. e1-3.CrossRefPubMedPubMedCentral
14.
Poulton BTS. The nursing cost of constipation. Primary. Health Care. 1999;9(9):17–22.
15.
Centre HaSCI. Prescribing and Primary Care Services; Health and Social Care Information Centre. Prescriptions Dispensed in the Community: England 2002–12..2013.
16.
Scott SM, van den Berg MM, Benninga MA. Rectal sensorimotor dysfunction in constipation. Best Pract Res Clin Gastroenterol. 2011;25(1):103–18.CrossRefPubMed
17.
Etherson KJ, Horrocks EJ, Scott SM, Knowles CH, Yiannakou Y. PWE-172 a national biofeedback practitioners service evaluation. Gut. 2014;63:A201.CrossRef
18.
Knowles CH, Dinning PG, Pescatori M, Rintala R, Rosen H. Surgical management of constipation. Neurogastroenterol Motil. 2009;21 Suppl 2:62–71.CrossRefPubMed
19.
20.
Bardisa-Ezcurra L, Ullman R, Gordon J. Diagnosis and management of idiopathic childhood constipation: summary of NICE guidance. BMJ. 2010;340:c2585.CrossRefPubMed
21.
Hooban S. NICE’s first guideline on idiopathic childhood constipation aims to standardise practice. Nurs Times. 2010;106(47):14.PubMed
22.
Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008;358(22):2344–54.CrossRefPubMed
23.
Lembo AJ, Cremonini F, Meyers N, Hickling R. Clinical trial: renzapride treatment of women with irritable bowel syndrome and constipation—a double-blind, randomized, placebo-controlled, study. Aliment Pharmacol Ther. 2010;31(9):979–90.PubMed
24.
Lembo AJ, Johanson JF, Parkman HP, Rao SS, Miner Jr PB, Ueno R. Long-term safety and effectiveness of lubiprostone, a chloride channel (ClC-2) activator, in patients with chronic idiopathic constipation. Dig Dis Sci. 2011;56(9):2639–45.CrossRefPubMedPubMedCentral
25.
Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, et al. Efficacy of linaclotide for patients with chronic constipation. Gastroenterology. 2010;138(3):886–95. e1.CrossRefPubMed
26.
Kamm MA, Dudding TC, Melenhorst J, Jarrett M, Wang Z, Buntzen S, et al. Sacral nerve stimulation for intractable constipation. Gut. 2010;59(3):333–40.CrossRefPubMed
27.
Maeda Y, Lundby L, Buntzen S, Laurberg S. Sacral nerve stimulation for constipation: suboptimal outcome and adverse events. Dis Colon Rectum. 2010;53(7):995–9.CrossRefPubMed
28.
Christensen P, Krogh K, Buntzen S, Payandeh F, Laurberg S. Long-term outcome and safety of trans-anal irrigation for constipation and fecal incontinence. Dis Colon Rectum. 2009;52(2):286–92.CrossRefPubMed
29.
Ausili E, Focarelli B, Tabacco F, et al. Transanal irrigation in myelomeningocele children: an alternative, safe and valid approach for neurogenic constipation. Spinal Cord. 2010;48:560–5.CrossRefPubMed
30.
Krogh K, Kvitzau B, Jorgensen T, Laurberg S. Treatment of anal incontinence and constipation with transanal irrigation. Ugeskr Laeger. 1999;161:253–6.PubMed
31.
Preziosi G, Gosling J, Raeburn A, Storrie J, Panicker J, Emmanuel A. Transanal irrigation for bowel symptoms in patients with multiple sclerosis. Dis Colon Rectum. 2012;55(10):1066–73.CrossRefPubMed
32.
Emmanuel A. Review of the efficacy and safety of transanal irrigation for neurogenic bowel dysfunction. Spinal Cord. 2010;48:664–73.CrossRefPubMed
33.
Etherson K, Yiannakou Y. Anal irrigation: a patient perception of treatment response in chronic constipation. Colorectal Dis. 2014;16:91.
34.
Marquis P, De La Loge C, Dubois D, McDermott A, Chassany O. Development and validation of the Patient Assessment of Constipation Quality of Life questionnaire. Scand J Gastroenterol. 2005;40(5):540–51.CrossRefPubMed
35.
Dubois D, Gilet H, Viala-Danten M, Tack J. Psychometric performance and clinical meaningfulness of the Patient Assessment of Constipation-Quality of Life questionnaire in prucalopride (RESOLOR) trials for chronic constipation. Neurogastroenterol Motil. 2010;22(2):e54–63.CrossRefPubMed
36.
37.
American College of Gastroenterology Chronic Constipation Task Force. An evidence-based approach to the management of chronic constipation in North America. Am J Gastroenterol. 2005;100:1–4.CrossRef
38.
Wade DT, Collin C. The Barthel ADL Index: a standard measure of physical disability? Int Disabil Stud. 1988;10(2):64–7.CrossRefPubMed
39.
Diamant NE, Kamm MA, Wald A, Whitehead WE. AGA technical review on anorectal testing techniques. Gastroenterology. 1999;116(3):735–60.CrossRefPubMed
40.
Rao SSC, Azpiroz F, Diamant N, Enck P, Tougas G, Wald A. Minimum standards of anorectal manometry. Neurogastroenterol Motil. 2002;14(5):553–9.CrossRefPubMed
41.
Carrington EV, Brokjaer A, Craven H, Zarate N, Horrocks EJ, Palit S, et al. Traditional measures of normal anal sphincter function using high-resolution anorectal manometry (HRAM) in 115 healthy volunteers. Neurogastroenterol Motil. 2014;26(5):625-35.
42.
Rao SS, Mudipalli RS, Stessman M, Zimmerman B. Investigation of the utility of colorectal function tests and Rome II criteria in dyssynergic defecation (Anismus). Neurogastroenterol Motil. 2004;16(5):589–96.CrossRefPubMed
43.
Bharucha AE, Dorn SD, Lembo A, Pressman A. American Gastroenterological Association medical position statement on constipation. Gastroenterology. 2013;144(1):211–7.CrossRefPubMed
44.
Ratuapli SK, Bharucha AE, Noelting J, Harvey DM, Zinsmeister AR. Phenotypic identification and classification of functional defecatory disorders using high-resolution anorectal manometry. Gastroenterology. 2013;144(2):314–22. e2.CrossRefPubMed
45.
46.
Jameson JS, Chia YW, Kamm MA, Speakman CTM, Chye YH, Henry MM. Effect of age, sex and parity on anorectal function. Br J Surg. 1994;81(11):1689–92.CrossRefPubMed
47.
Zarate N, Knowles CH, Newell M, Garvie NW, Gladman MA, Lunniss PJ, et al. In patients with slow transit constipation, the pattern of colonic transit delay does not differentiate between those with and without impaired rectal evacuation. Am J Gastroenterol. 2008;103(2):427–34.CrossRefPubMed
48.
49.
50.
Oncu K, Ozel AM, Demirturk L, Gurbuz AK, Yazgan Y, Kizilkaya E. Determination of the frequency of dyssynergic defecation and patient characteristics in patients with functional constipation. Turk J Gastroenterol. 2010;21(4):372–80.CrossRefPubMed
51.
52.
Evans RC, Kamm MA, Hinton JM, Lennard-Jones JE. The normal range and a simple diagram for recording whole gut transit-time. Int J Colorectal Dis. 1992;7(1):15–7.CrossRefPubMed
53.
Spitzer RL, Kroenke K, Williams JBW, Primary PHQ. Validation and utility of a self-report version of PRIME-MD—The PHQ primary care study. JAMA. 1999;282(18):1737–44.CrossRefPubMed
54.
55.
Kroenke K, Spitzer RL, Williams JBW. The PHQ-15: validity of a new measure for evaluating the severity of somatic symptoms. Psychosom Med. 2002;64(2):258–66.CrossRefPubMed
56.
Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006;166(10):1092–7.CrossRefPubMed
57.
Moss-Morris R, Weinman J, Petrie KJ, Horne R, Cameron LD, Buick D. The revised Illness Perception Questionnaire (IPQ-R). Psychol Health. 2002;17(1):1–16.CrossRef
58.
Fereday J, Muir-Cochrane E. Demonstrating rigor using thematic analysis: a hybrid approach of inductive and deductive coding and theme development. Int J Qual Methods 2006;5(1):80-92.
59.
Camilleri M, Van Outryve MJ, Beyens G, Kerstens R, Robinson P, Vandeplassche L. Clinical trial: the efficacy of open-label prucalopride treatment in patients with chronic constipation—follow up of patients from the pivotal studies. Aliment Pharmacol Ther. 2010;32:1113–23.CrossRefPubMed
Metadata
Title
Low-volume versus high-volume initiated trans-anal irrigation therapy in adults with chronic constipation: study protocol for a randomised controlled trial
Publication date
01-12-2017
Published in
Trials / Issue 1/2017
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-017-1882-y

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