Planned surgery for small bowel and/or colonic Crohn's disease (primary or repeat surgery) Surgery
Conditions
Interventions
The intervention is a minimum of 6 weeks of EEN pre-operatively. The control group is the usual diet.
Following randomisation into the trial, participants will be reviewed by the local dietitian, and
Sponsors
University of Birmingham
Eligibility
Sex/Gender
All
Age
16 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Any patient undergoing planned surgery for small bowel and/or colonic CD (primary or repeat surgery) 2. Age =16 years 3. Willingness to go on EEN for the duration of the intervention period (minimum of 6 weeks) 4. Capacity to give consent
Exclusion criteria
Exclusion criteria: 1. Surgery for peri-anal CD, ulcerative colitis, or inflammatory bowel disease unclassified (IBDU) 2. Patients who require parenteral nutrition in the 6 weeks prior to surgery 3. Inability to comply with the trial schedule and follow up
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Dual primary outcomes at 6 weeks post-surgery: 1. Crohn’s Life Impact Questionnaire (CLIQ; a CD-specific patient reported outcome assessing QoL) 2. Post-surgery complications using the Comprehensive Complication Index (CCI) If we demonstrate benefit for EEN on either of the primary outcomes this establishes effectiveness | — |
Secondary
| Measure | Time frame |
|---|---|
| Patient reported: 1. QoL over time using the CLIQ which will be collected post-surgery, fortnightly until 12 weeks post-surgery and then monthly up to 24 weeks post-surgery 2. Post-surgery recovery using the Surgical Quality of Recovery-15 (QoR-15) on day 3 post-surgery (or pre-discharge if discharged before day 3). The QoR-15 is a short form version of the QoR-40 and consists of 15 items each with a numerical rating score of 0-10. The total score therefore ranges from 0 to 150, with higher scores indicating better quality of recovery. Clinical: 3. Length of post-operative hospital stay (measured in nights in hospital) 4. Length of bowel resected (in centimetres measured along anti-mesenteric border) at time of surgery before being put in formalin 5. Number of anastomoses formed at surgery as documented in the operation notes or from discussion with the operating surgeon 6. Number of participants requiring stoma formation either at index operation or within 30 days of surgery due to re-operation 7. Number of participants who develop an anastomotic leak (either radiological concern or confirmed at reoperation) within 30 days of surgery 8. Number of participants re-admitted within 30 days of date of discharge 9. Number of participants requiring re-operation within 30 days of surgery 10. Number of participants who develop enterocutaneous fistulae within 90 days of surgery. This is defined as any new fistula tract from any point in the gastrointestinal tract opening on to skin at any site from day of surgery to 90 days later. Enterocutaneous fistula diagnosis can be confirmed following clinical assessment. Radiological confirmation is not required. 11. Number of participants who develop clinical recurrence of their CD at 24 and 52 weeks post-surgery as assessed by the Crohn’s Disease Activity Index (CDAI) 12. Number of participants who develop endoscopic disease recurrence assessed endoscopically on colonoscopy performed between 24 and 52 weeks post-surgery a | — |
Countries
England, Northern Ireland, Scotland, United Kingdom, Wales
Contacts
Public ContactPooja Gaddu
Outcome results
None listed