Assessing the length of Crohn's resection on disease recurrence

ISRCTN ISRCTN93472653
DOI https://doi.org/10.1186/ISRCTN93472653
ClinicalTrials.gov number NCT01876264
Secondary identifying numbers N/A
Submission date
03/06/2013
Registration date
25/10/2013
Last edited
31/07/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Background and study aims
Crohn's disease affects any part of the digestive system, most commonly the last part of the small intestine. It usually results in narrowing of the bowel at this point which can prevent food passing through normally. This can lead to abdominal pain, bloating and even vomiting. Whilst Crohn's disease is normally managed with medication, many patients require an operation to remove the affected portion of the bowel. During the operation the affected segment of bowel is removed and the ends of the remaining bowel are joined back together (an anastomosis). Following this, up to 60% of patients develop recurrent symptoms and up to 50% require a further operation. Recurrence of Crohn's disease at the site of the anastomosis can be detected as early as 6 months following surgery. This study is hoping to demonstrate that removing an additional length of small bowel may result in a lower risk of recurrence at the anastomosis, thereby decreasing the need for further surgery in the future.

Who can participate?
Anyone aged 16 or over who is undergoing an operation for Crohn's disease affecting the last part of the small bowel is potentially eligible to enter the study.

What does the study involve?
When patients with Crohn's disease undergo an operation to remove a length of bowel, the bowel is normally divided close (about 2 cm) to the abnormal segment. This is done in the hope of preserving the total length of bowel should future operations become necessary. Sometimes, there is inflammation at these cut ends and this has been associated with an increased risk of recurrence at the anastomosis. Patients who agree to enter the study will be randomly selected to have either an additional 8 cm of bowel removed (extended resection) or have no additional bowel removed (standard resection). At about 6 months after their operation they will undergo colonoscopy. This is to allow us to see the anastomosis visually and take samples from it to see if there are any early signs of disease recurrence.

What are the potential risks or benefits of participating in the trial?
Whilst there may be no immediate benefit to taking part in this study, participation will allow us to find out whether there is any potential benefit to patients with Crohn's disease undergoing an extended resection. This may benefit patients in the future if there is a clear reduction in the rate of disease recurrence at the site of the surgery. Patients in the study are subjected to exactly the same risks as patients who choose not to participate in the study. These risks are inherent to any operation on the intestines. The risks of the operation will be explained in full at the time of obtaining consent for your operation.

Where is the study run from?
The study is being run from The Churchill Hospital, which is part of Oxford University Hospitals NHS Trust, UK.

When is the study starting and how long is it expected to run for?
The study started in July 2013 and is expected to be completed in six years.

Who is the main contact?
Mr Richard Lovegrove, r.lovegrove@me.com
Mr Bruce George, bruce.george@ouh.nhs.uk

Contact information

Mr Richard Lovegrove
Scientific

Department of Colorectal Surgery
Churchill Hospital
Old Road
Headington
Oxford
OX3 7LJ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleCrohn's Extent of Resection Trial (CERT): a randomised controlled trial comparing anastomotic disease recurrence following 2-cm versus 10-cm resection margins for patients with ileocolic Crohn's disease
Study acronymCERT
Study objectivesTo assess whether undertaking a 10-cm resection margin leads to a reduction in:
1. Endoscopic evidence of disease recurrence at the surgical anastomosis 6 months following ileocolic resection
2. Postoperative disease-modifying medication
3. Symptomatic clinical recurrence
4. Need for reoperative surgery due to recurrence at the surgical anastomosis
Ethics approval(s)NRES Committee South Central - Berkshire B; 14/05/2013; 13/SC/0235
Minor amendments to patient information and consent forms to be made, approval pending.
Health condition(s) or problem(s) studiedCrohn's disease
InterventionTwo arms of the study are:
1. Conventional resection (2-cm margin)
2. Extended resection (10-cm margin)

The intervention group will have an additional 8 cm of distal small bowel resected at the time of ileocolic resection.
Intervention typeProcedure/Surgery
Primary outcome measureEndoscopic evidence of disease recurrence at the surgical anastomosis, assessed at 6 months postoperatively
Secondary outcome measures1. Duration of medication-free interval following resection
2. Duration of symptom-free interval following resection
3. Time to reoperation for anastomotic disease recurrence
4. Extent of plexitis in resected small bowel

Assessed from note review 5 years postoperatively
Overall study start date01/07/2013
Completion date01/07/2019

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants190
Key inclusion criteria1. Participant is willing and able to give informed consent for participation in the study
2. Male or female, aged 16 years or above
3. Patients with ileocolic Crohn’s disease requiring surgical resection
Key exclusion criteria1. Patients unable to give informed consent
2. Patients requiring formation of a stoma at the time of surgical resection
3. Patients having less than 200 cm of small bowel as assessed intraoperatively
4. Simultaneous strictureplasty or small bowel resection
5. Aged <16 or >80 years
Date of first enrolment01/07/2013
Date of final enrolment01/07/2019

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Department of Colorectal Surgery
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Oxford University Hospitals NHS Trust (UK)
Hospital/treatment centre

c/o Mr Bruce George
Churchill Hospital
Department of Colorectal Surgery
Old Road
Headington
Oxford
OX3 7LJ
England
United Kingdom

Website http://www.ouh.nhs.uk/hospitals/churchill/
ROR logo "ROR" https://ror.org/03h2bh287

Funders

Funder type

Hospital/treatment centre

Oxford University Hospitals NHS Trust (UK) - Surgical Metabolism Fund (0209)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
HRA research summary 28/06/2023 No No

Editorial Notes

31/07/2020: The NCT code has been added.