Crohn?s disease Digestive System Crohn's disease [regional enteritis]
Conditions
Interventions
Group 1: Hand sewn anastomosis
Group 2: Stapled anastomosis
Sponsors
Mount Sinai Hospital (Toronto) (Canada)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Women and men aged greater than 16 years 2. Elective ileocolonic resection 3. Colonoscopy and Small Bowel Endoscopy (SBE) completed with the last 3 years 4. Crohn?s Disease involving the terminal ileum plus or minus right colonic disease 5. No other sites of involvement with Crohn?s disease in the Gastrointestinal (GI) tract current or past 6. Willing to return for colonoscopy at 12 months
Exclusion criteria
Exclusion criteria: 1. Require emergency surgery 2. Have sites of Crohn?s involvement elsewhere, except for minimal perianal disease 3. Have had strictureplasties or other resections for Crohn?s disease performed either at this operation or previously, the exception being resections for fistula disease in bowel not affected by Crohn?s disease 4. Require a bypass procedure or defunctioning ileostomy during the index procedure 5. Have compromised renal function (serum creatinine level greater than 130 mmol/l or 1.5 mg/l) 6. Prednisone, budesonide, 5-Aminosalicylic Acid (5-ASA) medications, ciprofloxacin, metronidazole, cyclosporin and Anti-Tumour Necrotising Factor (Anti-TNF) and any other medications used to treat Crohn?s cannot be discontinued postoperatively 7. Are unable or willing to give informed consent and return for a colonoscopy at 12 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Severe endoscopic recurrence at one year follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Symptomatic recurrence (up to 24 months after) 2. Post-operative complication rates 3. Operative times | — |
Countries
Canada
Outcome results
None listed