Constipation - Functional, Faecal Incontinence, Functional Abdominal Pain Syndrome, Functional Dyspepsia, Irritable Bowel Syndrome, Other Rome IV Functional Gastrointestinal Disorders
Conditions
Keywords
Irritable bowel syndrome, Constipation, Functional dyspepsia, Multi-disciplinary treatment
Brief summary
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.
Interventions
OTHERMulti-disciplinary clinic model
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.
OTHERStandard outpatient care
Standard care provided in outpatient clinics staffed by GI doctors only
Sponsors
St Vincent's Hospital Melbourne
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Functional gastrointestinal disorder as defined by Rome IV
Exclusion criteria
* Diagnosed or suspicion of organic gastrointestinal disorder (ie Coeliac, IBD) * Age \<18 or \>80 * Non-English speaking * Patient's from outside of metropolitan Melbourne who cannot attend clinic visits * Prominent eating disorder * Chronic opioid dependence * Medications which can explain functional gut symptoms * Surgery of GI tract that can explain functional gut symptoms * Major, non-GI, organ dysfunction * Pregnancy * Major Psychiatric disorder
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with global improvement in their condition. | Definition of discharge timepoint: Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with constipation who score a 50% reduction in Cleveland clinic constipation scoring 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 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 | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | Scores from the EQ-5D will be compared between groups and QALY will be derived from EQ-5D. |
| 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 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 | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | $AUD per patient cost to the Australian healthcare system. |
| Proportion of subjects with global improvement in their condition. | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 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. |
| Proportion of subjects with a 50% reduction in gastrointestinal symptom severity index score | A) Day 1 of being discharged from clinic, or 9 months after baseline visit, whichever occurs first. B) 12 months after discharge. | 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. |
| 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. | — |
Countries
Australia
Outcome results
None listed