Study Stopped
Study abandoned
Crohn's Extent of Resection Trial
CERT
1 other identifier
interventional
N/A
1 country
1
Brief Summary
The trial will investigate if removing an additional length of small bowel will result in lower risk of recurrence at the surgical join (anastomosis), thereby decreasing the need for further surgery in the future.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Jun 2013
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
June 10, 2013
CompletedFirst Posted
Study publicly available on registry
June 12, 2013
CompletedAugust 7, 2020
August 1, 2020
Same day
June 10, 2013
August 5, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Endoscopic recurrence
The primary objective of the study is to assess whether undertaking a modest ileocolic resection (10cm margins) leads to a reduction in the incidence of Crohn's disease recurrence at the surgical anastomosis as assessed by colonoscopy 6 months post operatively, when compared to a conventional ileocolic resection (2cm margin).
6 months post operatively
Secondary Outcomes (4)
Medication-free interval
5 years post operatively
Symptom-free interval
5 years post operatively
Time to reoperation
5 years post operatively
Extent of plexitis
1 month postoperatively
Study Arms (2)
Extended resection
EXPERIMENTALPatients undergoing an extended resection are subjected to a traditional ileocolic resection with a 2cm macroscopically normal proximal margin. A further 8cm of ileum is then resected from the proximal margin prior to formation of the ileocolic anastomosis
Conventional resection
ACTIVE COMPARATORPatients undergoing a traditional ileocolic resection for Crohn's disease with a 2cm proximal macroscopically disease-free margin
Interventions
Eligibility Criteria
You may qualify if:
- Participant is willing and able to give informed consent for participation in the study.
- Male or Female, aged 16 years or above.
- Patients with ileocolic Crohn's disease requiring surgical resection
You may not qualify if:
- Patients unable to give informed consent
- Patients requiring formation of a stoma at the time of surgical resection
- Patients having less than 200cm of small bowel as assessed intra-operatively
- Simultaneous strictureplasty or small bowel resection
- Age \<16 or \>80
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oxford University Hospitals NHS Trust
Oxford, OX3 7LJ, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Richard E Lovegrove, MBBS MD FRCS
Worcestershire Acute Hospitals NHS Trust
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 10, 2013
First Posted
June 12, 2013
Study Start
June 1, 2013
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 7, 2020
Record last verified: 2020-08