The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE colitis - The ACCURE UK Trial Feasibility Study

Completed

• Conditions: Topic: Surgery, Gastroenterology; Subtopic: Surgery, Gastroenterology; Disease: All Surgery, All Gastroenterology; Digestive System; Ulcerative colitis

• Registration Number: ISRCTN56523019
• Lead Sponsor: niversity of Birmingham (UK)

Brief Summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25887789 2017 qualitative research results in https://www.ncbi.nlm.nih.gov/pubmed/28827271

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-10-29
• Study Completion: 2016-09-29
• Last Update Posted: 19 February 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 48

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified