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A randomised controlled trial to assess whether the amount of mesentery removed, or the type of bowel join used during surgery for Crohn's disease, can affect the chances of getting further disease

Not Applicable
Conditions
Crohn’s disease
Digestive System
Crohn disease [regional enteritis]
Registration Number
ISRCTN16900055
Lead Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Ongoing
Sex
All
Target Recruitment
308
Inclusion Criteria

People aged over 18 years undergoing ileocaecal resection for primary/recurrent Crohn’s disease where an anastomosis is carried out

Exclusion Criteria

Participant exclusion criteria as of 10/11/2023:
1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation
2. Patients undergoing stoma formation proximal to the anastomosis
3. Patients who have a contraindication to subsequent colonoscopy
4. Patients unable to give full informed consent
5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care)
6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery

Previous participant exclusion criteria:
1. Patients with markedly extensive inflammation affecting the vascular root of the mesentery seen on imaging or at operation
2. Patients undergoing stoma formation
3. Patients who have a contraindication to subsequent colonoscopy
4. Patients unable to give full informed consent
5. Patients who are pregnant (as ascertained by standard pregnancy tests undertaken at preoperative visits as per standard clinical care)
6. Patients who, in the opinion of the principal investigator, do not meet the criteria for relevant surgery

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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