Ulcerative colitis Digestive System Ulcerative colitis
Conditions
Interventions
Current intervention as of 27/10/2021:
This UK study will recruit up to 90 UC patients currently in disease remission and randomly allocate them into one of two groups, the appendicectomy group or the
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 29/03/2023: 1. Histologically confirmed Ulcerative Colitis 2. Disease relapse within 12 months prior to randomisation medically treated until remission 3. In clinical remission at time of randomisation with partial Mayo score less than 3 and presumptive endoscopic Mayo subscore of 0 or 1, identified by either: 3.1. Colonoscopy (within 3 months) examining the full length of the colon and rectum 3.2. Sigmoidoscopy (within 3 months) examining the last part of the colon (sigmoid and rectum) with faecal calprotectin less than 150 ug/g (within 3 months) 3.3 FCP less than 150 µg/g (within 3 months) with a personal history of raised FCP levels (>500 µg/g) during a previous disease flare-up at any stage 4. Aged 18 or over 5. Patient able and willing to give written informed consent _____ Previous participant inclusion criteria as of 27/10/2021: 1. Histologically confirmed Ulcerative Colitis 2. Disease relapse within 12 months of randomisation medically treated until remission 3. In clinical remission at time of randomisation with partial Mayo score less than 3 and presumptive endoscopic Mayo subscore of 0 or 1, identified by either: 3.1. Colonoscopy (within 3 months) examining the full length of the colon and rectum 3.2. Sigmoidoscopy (within 3 months) examining the last part of the colon (sigmoid and rectum) with faecal calprotectin less than 150 ug/g 3.3 FCP less than 150 µg/g (within 3 months) with a personal history of raised FCP levels (>500 µg/g) during a previous disease flare-up at any stage 4. Aged 18 or over 5. Patient able and willing to give written informed consent _____ Previous participant inclusion criteria: 1. Histologically confirmed Ulcerative Colitis 2. Disease relapse within 12 months of randomisation medically treated until remission 3. In clinical remission at time of randomisation with partial Mayo score less than 3 and presumptive endoscopic Mayo subscore of 0 or 1, identified by endoscopy (within 3 months). The endoscopy will be either: 3.1. Colonoscopy examining the full length of the colon and rectum 3.2. Sigmoidoscopy examining the last part of the colon (sigmoid and rectum) with faecal calprotectin less than 150 ug/g 4. Aged 18 or over 5. Patient able and willing to give written informed consent
Exclusion criteria
Exclusion criteria: Current participant exclusion criteria as of 27/10/2021: 1. Previous appendicectomy or other major abdominal surgery precluding safe laparoscopic appendicectomy 2. Any suspicion of Crohn’s disease 3. Disease recently treated with biologicals (within 3 months of randomisation) 4. Patients with significant comorbidity (e.g. unstable heart failure, liver or kidney failure, major lung co-morbidity) Previous participant exclusion criteria: 1. Previous appendicectomy or other major abdominal surgery precluding safe laparoscopic appendicectomy 2. Any suspicion of Crohn’s disease 3. Disease recently treated with biologicals (within 3 months of randomisation) 4. Severe disease ever treated with biologicals and stopped due to secondary non-response 5. Toxic megacolon or severe ongoing active colitis at time of randomisation 6. Patients with significant comorbidity (e.g. unstable heart failure, liver or kidney failure, major lung co-morbidity)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Current primary outcome measure as of 27/10/2021: One-year UC relapse rate (defined both clinically and endoscopically as Mayo score =5 with endoscopy subscore of 2 or 3), or in absence of endoscopy based on review by an independent critical event committee of clinical information suggesting relapse such as exacerbation of symptoms and rectal bleeding or FCP>150 (> 4 weeks after surgery) or intensified medical therapy other than 5-ASA therapy. Previous primary outcome measure: One-year UC relapse rate (defined both clinically and endoscopically as Mayo score =5 with endoscopy subscore of 2 or 3) | — |
Secondary
| Measure | Time frame |
|---|---|
| Current secondary outcome measures as of 29/03/2023: 1. Number of relapses per patient at 12 months 2. Time to first relapse (defined as time between randomisation in the control group or laparoscopic appendectomy in the intervention group and, the first day of clinical symptoms of an endoscopically or clinically confirmed relapse) 3. Health-related quality of life and costs measured using (EQ-5D-3L, EORTC-QLQ-C30-QL and IBDQ at 3, 6, 9 and 12 months post-randomisation 4. Disease activity, as measured with the Mayo score at 12 months or relapse (if earlier) 5. Colectomy rate at 12 months 6. Resource usage, including medication usage, diagnostic tests undergone outside of the trial (laboratory work, radiological and endoscopic assessments), inpatient costs and health professional interactions _____ Previous secondary outcome measures as of 27/10/2021: 1. Number of relapses per patient at 12 months 2. Time to first relapse (defined as time between randomisation in the control group or laparoscopic appendectomy in the intervention group and, the first day of clinical symptoms of an endoscopically or clinically confirmed relapse) 3. Health-related quality of life and costs measured using (EQ-5D-3L, EORTC-QLQ-C30-QL and IBDQ at 3, 6, 9 and 12 months post-randomisation 4. Disease activity measured with the Mayo score at 12 months or relapse 5. Colectomy rate at 12 months 6. Resource usage, including medication usage, diagnostic tests undergone outside of the trial (laboratory work, radiological and endoscopic assessments), inpatient costs and health professional interactions _____ Previous secondary outcome measures: 1. Number of relapses per patient at 12 months 2. Time to first relapse 3. Health-related quality of life and costs measured using (EQ-5D-3L, EORTC-QLQ-C30-QL and IBDQ at 3, 6, 9 and 12 months post-randomisation 4. Disease activity measured with the Mayo score at 12 months or relapse 5. Colectomy rate at 12 months 6. Resource usage, including medicati | — |
Countries
England, United Kingdom
Contacts
Public ContactManjinder;Ruth Kaur;Evans
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Outcome results
None listed