ACCURE-UK 2: the effects of appendix removal on ulcerative colitis

Not Applicable

Completed

• Conditions: lcerative colitis; Digestive System; Ulcerative colitis

• Registration Number: ISRCTN60945764
• Lead Sponsor: niversity of Birmingham

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-09-03
• Study Completion: 2023-11-01
• Last Update Posted: 8 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 202

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

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)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Current primary outcome measure as of 27/10/2021:<br>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.<br><br><br>Previous primary outcome measure:<br>One-year UC relapse rate (defined both clinically and endoscopically as Mayo score =5 with endoscopy subscore of 2 or 3)