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Randomised controlled trial comparing standard outpatient clinic treatment with multi-disciplinary clinic treatment for functional gastrointestinal disorders. Patients will be followed up to end of clinic treatment and 12 months beyond the end of treatment. Symptoms, quality of life, costs to the healthcare system and psychological outcomes will be assessed.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Multi-Disciplinary clinic | Active Comparator |
| |
| Standard Gastrointestinal clinic | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Multi-disciplinary clinic model | Other | Clinic model incorporating multiple disciplines for the treatment of functional gut disorders. Disciplines include: gastroenterologists, psychiatrists, psychologists, hypnotherapists, behavioural therapists and dieticians. End of clinic case conference involving clinical disciplines will also occur to coordinate care. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects with global improvement in their condition. | Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better. | Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects, with Irritable bowel syndrome or centrally mediated abdominal pain syndrome, with a 50% reduction in Irritable bowel syndrome severity scoring system (IBS-SSS) | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | |
| Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring system |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Chamara Basnayake, MBBS | Gastroenterologist / PhD candidate | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St Vincent's Hospital | Melbourne | Victoria | 3065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34896645 | Derived | Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Long-Term Outcome of Multidisciplinary Versus Standard Gastroenterologist Care for Functional Gastrointestinal Disorders: A Randomized Trial. Clin Gastroenterol Hepatol. 2022 Sep;20(9):2102-2111.e9. doi: 10.1016/j.cgh.2021.12.005. Epub 2021 Dec 9. | |
| 32679040 |
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|
| Standard outpatient care | Other | Standard care provided in outpatient clinics staffed by GI doctors only |
|
| A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Proportion of subjects with faecal incontinence who score a 50% reduction in St Mark's Incontinence score | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Proportion of subjects with functional dyspepsia who score a 50% reduction in the symptom score of the Nepean dyspepsia index | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Quality of life as measured by RAND SF-36 v1 | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Quality of life as measured by Euro-QOL EQ-5D | Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Psychological wellbeing as measured by hospital anxiety and depression score (HADS) | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B)12 months after discharge. |
| Proportion of subjects with who answer yes to: In the past 7 days, have you had adequate relief of your gut condition? [YES/NO] | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Somatisation as measured by somatic symptom scale-8 (SSS-8) | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Cost to the healthcare system | $AUD per patient cost to the Australian healthcare system. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Proportion of subjects with global improvement in their condition. | Global improvement in their condition is defined as a response of either "slightly better" or "much better" to the question: "Compared with before I was first seen in clinic, I feel my gut condition is now:". The question is marked on a 5-point likert scale: Much worse, slightly worse, same, slightly better, much better. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score | Patients will complete a GISSI (Gastrointestinal symptom severity index) questionnaire at time of "discharge from clinic" and 12 months after "discharge from clinic". The score used will be specific to their symptom cluster. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. |
| Derived |
| Basnayake C, Kamm MA, Stanley A, Wilson-O'Brien A, Burrell K, Lees-Trinca I, Khera A, Kantidakis J, Wong O, Fox K, Talley NJ, Liew D, Salzberg MR, Thompson AJ. Standard gastroenterologist versus multidisciplinary treatment for functional gastrointestinal disorders (MANTRA): an open-label, single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2020 Oct;5(10):890-899. doi: 10.1016/S2468-1253(20)30215-6. Epub 2020 Jul 14. |
| 31437539 | Derived | Basnayake C, Kamm MA, Salzberg M, Khera A, Liew D, Burrell K, Wilson-O'Brien A, Stanley A, Talley NJ, Thompson AJ. Defining Optimal Care for Functional Gut Disorders - Multi-Disciplinary Versus Standard Care: A Randomized Controlled Trial Protocol. Contemp Clin Trials. 2019 Sep;84:105828. doi: 10.1016/j.cct.2019.105828. Epub 2019 Aug 19. |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D004688 | Encopresis |
| D003248 | Constipation |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D019960 | Elimination Disorders |
| D001523 | Mental Disorders |
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