Crohn's Extent of Resection Trial

NCT ID: NCT01876264

Last Updated: 2020-08-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2013-06-30

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.

Detailed Description

The study will be conducted as a randomised controlled trial. The patient will be blinded to the procedure undertaken, as will the endoscopist performing the 6 month post operative colonoscopy. It is not possible to blind the operating team, for obvious reasons.

Patients undergoing elective or urgent ileocolic resection, both primary and redo resections, will be invited to participate in the trial. Randomisation will take place in the operating theatre after a conventional ileocolic resection has been performed. Those patients randomised to the modest resection (10cm margin) will have an additional 8cm of distal small bowel resected prior to the formation of the surgical anastomosis.

All patients will be seen in the colorectal clinic at approximately 6 weeks post operatively for their routine follow up appointment, as is current practice. A colonoscopy will be performed at 6 months post operatively to assess the anastomosis, in keeping with our current practice. Any additional follow up will be at the discretion of the colorectal or gastroenterological teams, in keeping with their clinical practice.

Patients recruited to the trial will not have any additional ongoing following up directly related to their trial participation. At 5 years following the recruitment of the a patient, the medical notes will be reviewed to identify those patients who have had symptomatic recurrence, further surgery and to assess the duration of medication-free interval following surgery.

Performing a colonoscopy at 6 months post operatively to assess the appearances of the surgical anastomosis will assess the primary endpoint. This will be performed by a senior gastroenterological trainee or consultant gastroenterologist who is familiar with assessment of post operative Crohn's disease and the Rutgeert's score. The appearances of the anastomosis will be scored, and biopsies taken from around the anastomosis to assess for microscopic changes. The use of the Rutgeert's score is widely accepted by the gastroenterological community as the standard assessment tool for post operative anastomotic disease recurrence in patients with Crohn's disease.

The duration of medication-free interval following resection will be assessed from review of the medical notes. This is clinically relevant to patients, as it has been previously shown that quality of life is improved in patients who do not have to take regular medication.

The duration of symptom-free interval will be assessed from review of the medical notes. This is clinically relevant to patients, as abdominal symptoms such as pain and bloating have a significantly deleterious effect on quality of life.

The duration of time to reoperation for Crohn's disease recurrence at the surgical anastomosis will be assessed from the clinical notes. This is of relevance to the patient population as well as the medical community. Crohn's disease commonly recurs, necessitating further surgery. Multiple operations resulting in resection of the bowel results in a reduction in the length of bowel available for absorption of nutrients from food. Ultimately, patients may develop short bowel syndrome. This requires total parenteral nutrition, with the associated risks this carries, and may require small bowel transplantation.

Conditions

Crohn's Disease; Recurrence

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Extended resection

Patients 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

Group Type: EXPERIMENTAL

Extended resection

Intervention Type: PROCEDURE

Conventional resection

Patients undergoing a traditional ileocolic resection for Crohn's disease with a 2cm proximal macroscopically disease-free margin

Group Type: ACTIVE_COMPARATOR

Conventional resection

Intervention Type: PROCEDURE

Interventions

Extended resection

Intervention Type: PROCEDURE

Conventional resection

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Oxford University Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Richard E Lovegrove, MBBS MD FRCS

Role: PRINCIPAL_INVESTIGATOR

Worcestershire Acute Hospitals NHS Trust

Locations

Oxford University Hospitals NHS Trust

Oxford, , United Kingdom

Countries

United Kingdom

Other Identifiers

CERT2013

Identifier Type: -

Identifier Source: org_study_id