Topic: Surgery, Gastroenterology
Conditions
Interventions
Before randomisation, patients will undergo radiophysiological investigations (INVEST) and the relationship between these test results and response to treatment will also be explored. Eligible patient
Sponsors
Queen Mary University of London (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Quality of life is measured using the Patient Assessment of Constipation Quality of Life questionnaire (PAC-QOL35, 36) at 3 months. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Disease specific outcomes are measured using PAC-QOL score and individual domain scores at baseline, 1, 3, 6, and 12 months 2. Time to cessation of each system of irrigation and total time in treatment with either system is determined using the irrigation journal at baseline, 1, 3, 6, and 12 months 3. Reason for cessation of each system is determined using the irrigation journal and qualitative interviews at baseline, 1, 3, 6, and 12 months 4. Disease specific outcomes are measured using Patient Assessment of Constipation Symptoms (PAC-SYM): aggregate and domain scores at baseline, 1, 3, 6, and 12 months 5. Volume and duration of irrigation (irrigation journal) at baseline, 1, 3, 6, and 12 months 6. Number and nature of bowel motions (captured in 2-week patient diary) at baseline, 3, 6 and 12 months 7. Symptom scores derived from diary records are taken over two weeks before or around each follow-up contact (these will include number of spontaneous complete bowel motions) at baseline, 3, 6 and 12 months 8. Disease specific outcomes are measured using Generalized anxiety disorder questionnaire (GAD7) at baseline, 3, 6 and 12 months 9. Disease specific outcomes are measured using Depression, anxiety and somatisation modules of the PHQ-9 at baseline, 3, 6 and 12 months 10. Disease specific outcomes are measured using Global patient satisfaction/improvement score (VAS) at baseline, 3, 6 and 12 months 11. Patient acceptability and recommendation to other patients is assessed using qualitative interviews 12. Disease specific outcomes are measured using Behavioural response to illness questionnaire (CC-BRQ), and brief illness perception questionnaire BIPQ (CC) at baseline, 3, 6 and 12 months 13. Generic quality of life is measured using EuroQol EQ-5D-5L and EQ-VAS at bas | — |
Countries
England, Scotland, United Kingdom
Contacts
Public ContactShiva Taheri
Outcome results
None listed