CapaCiTY Study 2 - Chronic Constipation Treatment Pathway

Not Applicable

Completed

• Conditions: Topic: Surgery, Gastroenterology; Subtopic: Gastroenterology; Disease: All Gastroenterology; Digestive System; Chronic constipation

• Registration Number: ISRCTN11093872
• Lead Sponsor: Queen Mary University of London (UK)

Brief Summary

2017 Protocol article in https://www.ncbi.nlm.nih.gov/pubmed/28359279 protocol 2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34855315/ (added 27/10/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-11
• Study Completion: 2019-12-31
• Last Update Posted: 7 November 2022

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

1. Aged between 18 and 70 years
2. Patient self reports problematic constipation
3. Symptom onset > 6 months before 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
8. Failure of previous nurse-led behavioural therapy
9. Ability of patient / carer to use anal irrigation

Exclusion Criteria

1. Significant organic colonic disease (red flag symptoms e.g. rectal bleeding previously 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 not an exclusion)
2. Major colorectal resectional surgery
3. Current overt pelvic organ prolapse (bladder, uterus, vagina, rectum) or disease requiring surgical intervention
4. Previous pelvic floor surgery to address defaecatory problems: posterior vaginal repair, STARR and rectopexy;previous sacral nerve stimulation
5. Previous use of transanal irrigation therapy to treat constipation
6. Rectal impaction (as defined by digital and abdominal examination: these form part of the NHS Map of Medicine basic standard)
7. Significant neurological disease deemed to be causative of constipation e.g. Parkinson’s, spinal injury, multiple sclerosis, diabetic neuropathy (not uncomplicated diabetes alone)
8. Significant connective tissue disease: scleroderma, systemic sclerosis and SLE (not hypermobility alone)
9. Significant medical comorbidities and activity of daily living impairment (based on Bartell index in apparently frail patients, Bartel index <=11)
10. Physical disability/impairment which prevents use of one or other of the irrigation devices
11. Major psychiatric diagnosis (e.g. schizophrenia, major depressive illness, mania, self harm and drug/alcohol addiction)
12. 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
13. Pregnancy or intention to become pregnant during study period

Study & Design

• Study Type: Interventional
• Study Design: Not specified