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| Name | Class |
|---|---|
| County Durham and Darlington NHS Foundation Trust | OTHER_GOV |
| University of York | OTHER |
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The primary objective is to compare the effectiveness of the experimental Intermittent Colonic Exoperistalsis (ICE) treatment with MOWOOT, with the active control of trans-anal irrigation (TAI) as standard-of-care. The secondary objectives are to further compare the ICE treatment with MOWOOT to the TAI standard-of-care clinically and economically.
The RCT will assess clinical effectiveness by means of quantitative and qualitative variables, and the cost effectiveness by means of economic outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intermittent Colon Exoperistalsis (ICE) | Experimental | Intermittent Colon Exoperistalsis (ICE) Treatment with Mowoot device. 20min daily for 12 weeks |
|
| Standard-of-care with Trans-anal Irrigation (Soc TAI) | Active Comparator | Standard-of-care with Trans-anal Irrigation (Soc TAI) for chronic constipation for 12 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Colonic Exoperistalsis with MOWOOT device | Device | Patients under the experimental arm of the study should place the belt of the Mowoot device on the abdomen and use it for 20 minutes every day for 12 weeks. They should continue with their individualized standard of care againts constipation for the first 4 weeks. During the following 8 weeks of the interventional period of 12weeks, their use of SocTAI will be considered "rescue intervention". The 8weeks following the 12weeks of intervention, they can keep on using ICE device.or SocTAI or both. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in quality of life (PAC-QoL) | Semi-quantitative assessment of the changes in quality of life respect to chronic constipation, of patients using the ICE treatment with MOWOOT compared with patients under standard of care treatment. The measure is done according to PAC-QoL questionnaire. | End of treatment (week 14, last week of treatment) - Baseline (before treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of use of TAI | How many days per week the patient has used TAI | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Frequency of use of ICE |
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Inclusion Criteria:
Exclusion Criteria:
Disease phenotype exclusion criteria:
Irritable Bowel Syndrome with Diarrhoea (IBS-D) or alternating constipation and diarrhoea (IBSmix): (not due to laxative use)
Inflammatory Bowel Disease (IBD)
Device-related exclusion criteria:
Abdominal perimeter ≤65cm or ≥130cm
Unable to independently use the MOWOOT or TAI technology, unless a carer is available daily to assist
Other medical conditions, medications and contraindications:
Previous large bowel resection
The presence of a stoma
External rectal prolapse
Active anorexia or bulimia
Active abdominal cancer
Large inguinal or umbilical hernia
Recent abdominal scars, abdominal wounds or skin disorders that may make abdominal massage uncomfortable
Pregnancy or attempt to become pregnant in the next 6 months
Use of strong opioids*
Use of antidepressants, bladder stabilisers or any other medication inducing, or treating, constipation unless used at a stable dose for at least 4 weeks before Screening Visit (this excludes laxatives which may be used as required up to three days before the screening visit)
Subjects already undertaking or have undertaken abdominal massage unless they underwent a previous washout period of at least 2 months
Participation in another parallel interventional clinical trial or less than 2 months from participation in a previous interventional clinical trial
Planned surgery for constipation if it might be within trial dates
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| Name | Affiliation | Role |
|---|---|---|
| Immaculada Herrero, PhD | usMIMA S.L. | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of North Durham, NHS Foundation Trust | Durham | County Durham and Darlington | DH5TW | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17117000 | Background | Ayas S, Leblebici B, Sozay S, Bayramoglu M, Niron EA. The effect of abdominal massage on bowel function in patients with spinal cord injury. Am J Phys Med Rehabil. 2006 Dec;85(12):951-5. doi: 10.1097/01.phm.0000247649.00219.c0. | |
| 19283590 | Background | Diego MA, Field T. Moderate pressure massage elicits a parasympathetic nervous system response. Int J Neurosci. 2009;119(5):630-8. doi: 10.1080/00207450802329605. |
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Randomized controlled trial
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|
| Standard of care with Trans-Anal Irrigation | Device | Patients under the active comparator arm of the study should continue with their individualized standard of care againts constipation for the 12weeks of intervention. The following 8 weeks they can keep on using SocTAI or ICE device or both. |
|
How many days per week the patient has used ICE
| Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in Constipation symptoms (PAC-SYM) | Semi-quantitative assessment of the changes in symptoms of constipation of patients using the ICE treatment with MOWOOT compared with patients under standard of care treatment. The measure is done according to PAC-SYM questionnaire. | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Changes in quality of life according to Euroqol ED5D5L | Semi-quantitative assessment of the changes in self-perceived quality of life according to the EQ-5D-5L instrument | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Changes in the number of days evacuation felt complete | Quantitative assessment of the change in the number of days per week evacuation felt complete at the end of the day | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in the maximum number of consecutive days without complete bowel movements | Quantitative assessment of the change in the maximum number of consecutive days within the 2-week diary period without complete bowel movementscomplete at the end of the day | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in the number of days with a normal stool | Quantitative assessment of the change in the number of days with a normal stool (Bristol Stool Scale 3-5) during the 2-week diary period | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in the mean time spent in bowel management | Quantitative assessment of the change in the mean time spent in bowel management per week | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in the mean time spent per evacuation | Quantitative assessment of the change in the mean time spent per evaquation | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in the number of days with fecal incontinence | Quantitative assessment of the change in the number of days with fecal incontinence per week | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in laxative use | Quantitative assessment of the change in the number of days per week taking laxatives | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Changes in the use of SoC TAI (HE outcome) | Quantitative assessment of the changes in number of people (%) who stop using TAI while using ICE with MOWOOT during the 12-week RCT period; and mean/median change in the use of TAI while using Mowoot during the 12-week RCT period | Diary collected during the 2-week baseline period and for the last 2 weeks of the RCT period, and post-RCT period. |
| Number of visits to GP and specialists (HE outcome) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of visits to GP and specialists (in primary care centres, hospitals, or visits received at home) over the previous 8 weeks | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Number of visits to Accident & Emergency room (HE outcome) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of visits to to Accident & Emergency room (A&E) over the previous 8 weeks
| 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Continence Service consultations (HE outcome) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of continence Service consultations (face-to-face visits and/or phone calls) over the previous 8 weeks | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Number of hospital admissions (HE outcome) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the number of hospital admissions over the previous 8 weeks | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Days spent at hospital (HE outcome) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the days spent at hospital over the previous 8 weeks | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Use of relevant medications (HE outcome) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the use of relevant medications, including opioids, antidepressants, bladder stabilisers or any other medication inducing constipation, over the previous 8 weeks | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Use of relevant supplies (HE outcome) | Quantitative assessment of the changes in the direct medical healthcare costs due to constipation-related problems assessed as the use of relevant supplies (diapers, protector sheets, suppositories and micro-enemas), over the previous 8 weeks | 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Incremental cost/effectiveness ratio (ICER) and Quality-Adjusted Life years (QALYS) (HE outcome) | Quantitative assessment of the of ICER and QALYS based on the health-related quality of life questionnaire EQ-5D-5L | EQ-5D-5L3 answered 3 times during the follow-up: Once at visit 1 (day 14 after recruitment), once at visit 2 (day 42 after treatment), and once more at visit 3 (day 154 after recruitment) |
| Adverse events and Serious adverse events | Quantitative and qualitative assessment of adverse events (AEs) and serious adverse events (SAEs) | Evrey day during all the follow-up, from recruitment (visit 0, day 0) to the end of study (visit 3, day 154) |
| University Hospital of North Tees, North Tees & Hartlepool NHS Foundation Trust |
| Hardwick |
| United Kingdom |
| The Newcastle Upon Tune Hospitals NHS Foundation Trust. | Newcastle upon Tyne | United Kingdom |
| 21943617 | Background | Sinclair M. The use of abdominal massage to treat chronic constipation. J Bodyw Mov Ther. 2011 Oct;15(4):436-45. doi: 10.1016/j.jbmt.2010.07.007. Epub 2010 Aug 25. |
| 16036506 | Background | 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 May;40(5):540-51. doi: 10.1080/00365520510012208. |
| 10522604 | Background | Frank L, Kleinman L, Farup C, Taylor L, Miner P Jr. Psychometric validation of a constipation symptom assessment questionnaire. Scand J Gastroenterol. 1999 Sep;34(9):870-7. doi: 10.1080/003655299750025327. |
| 27147121 | Background | Drossman DA, Hasler WL. Rome IV-Functional GI Disorders: Disorders of Gut-Brain Interaction. Gastroenterology. 2016 May;150(6):1257-61. doi: 10.1053/j.gastro.2016.03.035. No abstract available. |
| 28983926 | Background | Yiannakou Y, Tack J, Piessevaux H, Dubois D, Quigley EMM, Ke MY, Da Silva S, Joseph A, Kerstens R. The PAC-SYM questionnaire for chronic constipation: defining the minimal important difference. Aliment Pharmacol Ther. 2017 Dec;46(11-12):1103-1111. doi: 10.1111/apt.14349. Epub 2017 Oct 6. |
| 29768326 | Background | Forootan M, Bagheri N, Darvishi M. Chronic constipation: A review of literature. Medicine (Baltimore). 2018 May;97(20):e10631. doi: 10.1097/MD.0000000000010631. |
| 20557387 | Background | Lamas K, Lindholm L, Engstrom B, Jacobsson C. Abdominal massage for people with constipation: a cost utility analysis. J Adv Nurs. 2010 Aug;66(8):1719-29. doi: 10.1111/j.1365-2648.2010.05339.x. Epub 2010 Jun 16. |
| 33512794 | Background | McClurg D, Booth L, Herrero-Fresneda I. Safety and Efficacy of Intermittent Colonic Exoperistalsis Device to Treat Chronic Constipation: A Prospective Multicentric Clinical Trial. Clin Transl Gastroenterol. 2020 Dec;11(12):e00267. doi: 10.14309/ctg.0000000000000267. |
| 37516745 | Background | Bremer J, Bremer J, Konig M, Kossmehl P, Kurze I, Obereisenbuchner J, Weinschenk E, Herrero-Fresneda I. Intermittent colonic exoperistalsis for chronic constipation in spinal cord-injured individuals. A long-term structured patient feedback survey to evaluate home care use. Spinal Cord Ser Cases. 2023 Jul 29;9(1):37. doi: 10.1038/s41394-023-00597-z. |
| 27557052 | Result | Emmanuel A, Kumar G, Christensen P, Mealing S, Storling ZM, Andersen F, Kirshblum S. Long-Term Cost-Effectiveness of Transanal Irrigation in Patients with Neurogenic Bowel Dysfunction. PLoS One. 2016 Aug 24;11(8):e0159394. doi: 10.1371/journal.pone.0159394. eCollection 2016. |
| ID | Term |
|---|---|
| D003248 | Constipation |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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