Condition category
Digestive System
Date applied
03/06/2013
Date assigned
25/10/2013
Last edited
25/10/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Mr Richard Lovegrove

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Crohn’s Extent of Resection Trial (CERT): a randomised controlled trial comparing anastomotic disease recurrence following 2cm versus 10cm resection margins for patients with ileocolic Crohn’s disease

Acronym

CERT

Study hypothesis

To assess whether undertaking a 10cm 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

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.

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Crohn's disease

Intervention

Two arms of the study are:
1. Conventional resection (2cm margin)
2. Extended resection (10cm margin)

The intervention group will have an additional 8 cm of distal small bowel resected at the time of ileocolic resection.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Endoscopic evidence of disease recurrence at the surgical anastomosis, assessed at 6 months postoperatively

Secondary outcome measures

1. 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 trial start date

01/07/2013

Overall trial end date

01/07/2019

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

1. 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. Age <16 or >80

Recruitment start date

01/07/2013

Recruitment end date

01/07/2019

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Colorectal Surgery
Oxford
OX3 7LJ
United Kingdom

Sponsor information

Organisation

Oxford University Hospitals NHS Trust (UK)

Sponsor details

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

Sponsor type

Hospital/treatment centre

Website

http://www.ouh.nhs.uk/hospitals/churchill/

Funders

Funder type

Hospital/treatment centre

Funder name

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

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes