CapaCiTY study 1-chronic constipation treatment pathway
- Conditions
- Topic: Primary Care, GastroenterologySubtopic: Gastroenterology, GastroenterologyDisease: All Diseases, All GastroenterologyDigestive System
- Registration Number
- ISRCTN11791740
- Lead Sponsor
- Queen Mary University of London
- Brief Summary
2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28340625 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34855315/ (added 27/10/2022)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 394
1. Age 18-70 years
2. Patient self-reports problematic constipation
3. Symptom onset > 6 months prior to recruitment
4. Symptoms meet American College of Gastroenterology definition of constipation
5. Constipation failed treatment to a minimum basic standard (NHS Map of Medicine 2012 (lifestyle AND dietary measures AND =2 laxatives or prokinetics) tried (no time requirement)
6. Ability to understand written and spoken English (due to questionnaire validity)
7. Ability and willingness to give informed consent
The study will use the American College of Gastroenterology definition of constipation (which is reasonable, simple and extensively published): unsatisfactory defaecation characterized by infrequent stool, difficult stool passage or both for at least previous 3 months. This avoids the more complex Rome definitions (which are likely to change with Rome IV in 2015).
The study interventions necessitate the exclusion of major causes of secondary constipation. In detail:
1. Significant organic colonic disease (red flag symptoms e.g. rectal bleeding prior investigated); IBD; megacolon or megarectum (if diagnosed beforehand) [the study will provide a useful estimate of the prevalence of such cases in referral practice]; severe diverticulosis/stricture/birth defects deemed to contribute to symptoms (incidental diverticulosis if known not an exclusion).
2. Major colorectal resectional surgery
3. Overt pelvic organ prolapse (bladder, uterus, rectum) or disease requiring obvious surgical intervention
4. Previous pelvic floor surgery to address defaecatory problems: posterior vaginal repair, STARR and rectopexy; previous sacral nerve stimulation
5. Rectal impaction (as defined by digital and abdominal examination: these form part of the NHS Map of Medicine basic standard)
6. Significant neurological disease deemed to be causative e.g. Parkinson’s, spinal injury, multiple sclerosis, diabetic neuropathy (not uncomplicated diabetes alone)
7. Significant connective tissue disease: scleroderma, systemic sclerosis and SLE (not hypermobility alone)
8. Significant medical comorbidities and activity of daily living impairment [based on Bartell index in apparently frail patients, Bartell index <=11]
9. Major active psychiatric diagnosis [schizophrenia, major depressive illness and mania]
10. Chronic regular opioid use (at least once daily use) where this is deemed to be the cause of constipation based on temporal association of symptoms with onset of therapy; all regular strong opioid use
11. Pregnancy or intention to become pregnant during study period
12. Previous nurse-led bowel management
13. Severe visual impairment sufficient to prevent visual biofeedback
Urinary pregnancy testing will be made available to women of child-bearing potential at eligibility assessment and advice will be given to all women regarding need to prevent pregnancy during the study intervention period. Serum pregnancy testing will be mandatory for women of childbearing potential randomized to the INVEST group based on the NHS 10 day rule
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Response to treatment defined as a 0.4 point [changed from 1-point on 10/05/2016] (or greater) reduction in PAC-QOL score at 6 months post end of treatment)
- Secondary Outcome Measures
Name Time Method