Patients with bowel symptoms including symptoms of constipation or disorder of evacuation, faecal incontinence functional anorectal pain, faecal urgency and frequency of moving bowels, or a constant urge to move bowels Digestive System
Conditions
Interventions
Intervention: Rectal barostat test.
All participants will have the rectal barostat test, but the order of tests will be changed per patient to avoid bias on the order of tests influencing the results.
Sponsors
Newcastle upon Tyne Hospitals NHS Foundation Trust
Eligibility
Sex/Gender
All
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years 2. Aged under 90 years 3. Male or nonpregnant female 4. Meets 1 or more of the following indications for anorectal physiology investigations: symptoms of constipation or disorder of evacuation, faecal incontinence functional anorectal pain, faecal urgency and frequency of moving bowels, constant urge to move bowels 5. Has had a previous lower gastrointestinal tract investigation (colonoscopy, flexible sigmoidoscopy, defecating proctogram, digital rectal examination, CT colon) in the past 2 years 6. Able to understand both written and verbal English
Exclusion criteria
Exclusion criteria: 1. Creutzfeldt-Jakob disease 2. Pregnancy 3. Previous rectal surgery 4. Previous pelvic radiotherapy 5. Haemorrhoid banding in past 2 weeks 6. Haemorrhoidectomy in past 10 weeks 7. Reporting of change of bowel habits, rectal bleeding, or weight loss with no endoscopic investigations performed since symptoms commenced 8. History of inflammatory bowel disease 9. History of colorectal or anal cancer 10. Lack of capacity to consent 11. Over 90 years old 12. Under 18 years old
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The number of patients who were eligible to participate in the study per site from the start to the end of recruitment 2. The number of eligible patients who chose to participate in the study from the start to the end of recruitment 3. The number of participants that dropped out of the study from the start to the end of recruitment 4. The respective costs (£) of the rectal barostat test and the elastic balloon distension test per patient measured using a bottom-up approach (total staff time costed (£) per patient appointment including additional time (min) required for rectal barostat test + cost of rectal barostat bags (£) and (standard staff time (min) costed as allocated for standard patient appointment (£)+ No addition cost of the rectal barostat bags). 5. The time taken per participant for the elastic balloon distension test and the rectal barostat test to be completed in minutes/seconds, from the start of inflation to full deflation at the end of the test 6. Participant rectal barostat test acceptability measured by willingness to undergo the rectal barostat test again measured using the rectal sensitivity testing questionnaire at the end of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The London Classification diagnosis per patient as assessed by the elastic balloon distension test and the rectal barostat test at the end of the study 2. Rectal capacity in mL per participant as measured from the rectal barostat test at the end of the study 3. The percentage of rectal capacity for each sensory threshold (first sensation, normal urge, maximum tolerated volume) for all three rounds of sensation testing during the rectal barostat test at the end of the study 4. The difference in patient-reported comfort levels of the rectal barostat test and elastic balloon distension test measured using the rectal sensitivity testing questionnaire at the end of the study 5. Qualitative themes reported by study participants which may improve the patient experience of a future study. Assessed using open-ended questions from the rectal sensitivity questionnaire at the end of the study | — |
Countries
England, United Kingdom
Contacts
Public ContactNatalie Page
Outcome results
None listed