The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE colitis - The ACCURE UK Trial Feasibility Study: a randomised clinical trial

niversity of Birmingham (UK)0 个研究点目标入组 48 人开始时间: 2014年10月29日最近更新: 2018年2月19日

适应症

试验速览

•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

•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

发起方

niversity of Birmingham (UK)