Topic: Surgery, Gastroenterology
Conditions
Interventions
24 patients will be randomised to the control (standard medical therapy), 24 patients will be randomised to the intervention (appendicectomy) plus standard medical therapy.
The intervention is the re
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 19/01/2018: The target population for this study is adults with established and recently active UC. The inclusion criteria are as follows: 1. Histologically confirmed UC 2. Disease relapse within 12 months of randomisation 3. In clinical remission at time of randomisation with clinical Mayo score less than 3 and presumptive endoscopic Mayo score of 0 or 1 (to be confirmed later at baseline endoscopy) 4. Aged at least 18 5. Able and willing to give written informed consent Previous inclusion criteria: The target population for this study is adults with established and recently active UC. The inclusion criteria are as follows: 1. Histologically confirmed UC 2. Disease relapse within 12 months of randomisation 3. In clinical remission at time of randomisation with clinical Mayo score less than 3 and endoscopic Mayo score of 0 or 1 4. Aged at least 18 5. Able and willing to give written informed consent 6. Male & Female
Exclusion criteria
Exclusion criteria: Current exclusion criteria as of 19/01/2018: 1. Previous appendicectomy 2. Previous major abdominal surgery which would preclude safe laparoscopic appendicectomy 3. Uncertain histological findings and any suspicion of Crohn's disease 4. Infective diarrhoea confirmed by positive stool culture 5. Ongoing active colitis at time of randomisation 6. Patients still on steroid medication for ongoing active or previously active colitis at time of randomisation 7. Patients with significant comorbidity that prevents surgery (eg unstable heart failure) 8. Under the age of 18 9. Unable/unwilling to provide informed consent Previous exclusion criteria: 1. Previous appendicectomy 2. Previous major abdominal surgery which would preclude safe laparoscopic appendicectomy 3. Uncertain histological findings and any suspicion of Crohn's disease 4. Infective diarrhoea 5. Severe ongoing colitis at time of randomisation 6. Patients with significant comorbidity (eg unstable heart failure) 7. Enrollment in other trial of any novel treatment (including drugs or other interventions) for UC within preceding 6 months 8. Under the age of 18 9. Unable/unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Acceptability of the intervention. Timepoint(s): Baseline, 6 weeks post surgery and 12 months post-randomisation. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Determine the suitability of the QoL outcome measures. Timepoint(s): Analysis of suitability will be after all the collection time-points (>12months) 2. Estimate the morbidity profile of the appendicectomy operation. Timepoint(s): Data will be collected 6 weeks post-surgery 3. Patient-related outcomes e.g. disease-related work absence and loss of earnings. Timepoint(s): 6 weeks post randomisation, 3, 6, 9 & 12 months post randomisation 4. Relapse rate in the control arm. Timepoint(s): This will be collected throughout the trial, at 3, 6, 9 & 12 months; 5. Test the one-year follow-up strategy for the future phase III trial. Timepoint(s): Basline, 6 weeks post surgery, 3, 6, 9 & 12months post randomisation 6. The numbers of eligible, approached and randomised patients. Timepoint(s): During recruitment phase only- 6 months | — |
Countries
United Kingdom
Outcome results
None listed