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Register:	ISRCTN
Last refreshed on:	19 February 2018
Main ID:	ISRCTN56523019
Date of registration:	29/10/2014
Prospective Registration:	Yes
Primary sponsor:	University of Birmingham (UK)
Public title:	The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE colitis - The ACCURE UK Trial Feasibility Study
Scientific title:	The feasibility of undertaking Appendicectomy to impact upon the Clinical Course of UlceRativE colitis - The ACCURE UK Trial Feasibility Study: a randomised clinical trial
Date of first enrolment:	20/11/2014
Target sample size:	48
Recruitment status:	Completed
URL:	http://isrctn.com/ISRCTN56523019
Study type:	Interventional
Study design:	Randomised; Interventional; Design type: Treatment (Treatment)
Phase:

Countries of recruitment
United Kingdom

Contacts

Name:
Address:
Telephone:
Email:
Affiliation:

Name:	Laura Magill
Address:	Birmingham Clinical Trials Unit (BCTU) Institute of Applied Health Research College of Medical and Dental Sciences Public Health Building Edgbaston B15 2TT Birmingham United Kingdom
Telephone:	+44 121 415 9106
Email:	Accure@trials.bham.ac.uk
Affiliation:

Key inclusion & exclusion 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: 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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

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

Intervention(s)

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 removal of the appendix as a treatment for ulcerative colitis alongside standard medical therapy.

Follow Up Length: 12 month(s)

Primary Outcome(s)

1. Acceptability of the intervention. Timepoint(s): Baseline, 6 weeks post surgery and 12 months post-randomisation.

Secondary Outcome(s)

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

Secondary ID(s)

17515

Source(s) of Monetary Support

NIHR Research for Patient Benefit (RfPB); Grant Codes: PB-PG-1112-29107

Secondary Sponsor(s)

Ethics review

Status:
Approval date:
Contact:

Tyne and Wear South Ethics Committee, 24/10/2014, ref. 14/NE/1143

Results

Results available:	Yes
Date Posted:
Date Completed:	29/09/2016
URL:

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