Stapled side-to-side anastomosis versus sutured end-to-end anastomosis following resection for primary or recurrent Crohn's disease

Completed

• Conditions: Crohn?s disease; Digestive System; Crohn's disease [regional enteritis]

• Registration Number: ISRCTN72500766
• Lead Sponsor: Mount Sinai Hospital (Toronto) (Canada)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-09
• Last Update Posted: 13 January 2015

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 200

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified