Kono-S Anastomosis Versus the Side-to-side Functional End AnastomosisProspective randomized study of the Kono-S anastomosis versus the side-to-side functional end anastomosis in the prevention of post-operative recurrence of Crohn’s disease
Early Phase 1
Recruiting
- Conditions
- Crohns diseaseK50Crohn disease [regional enteritis]
- Registration Number
- DRKS00020527
- Lead Sponsor
- Theresienkrankenhaus Allgemein- und Viszeralchirurgie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 262
Inclusion Criteria
• Patients with Crohn’s terminal ileitis age 18 or older requiring surgical resection
• All phenotypes will be included: nonstricturing nonpenetrating (B1), stricturing (B2), and penetrating (B3), according to the Vienna classification
• Patients on any medications prior to surgery, including anti-TNF therapy
Exclusion Criteria
• Patients with recurrent Crohn’s
• Patients with Crohn’s disease extending to the cecum and ascending colon
• Patient who will need preventive medical treatment for Crohn’s disease after surgery
• Patients that may need a different surgical procedure as per the surgeon at the time of the intraoperative abdominal evaluation
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary aim of the study is to compare the post-operative recurrence of Crohn’s disease using the Rutgeerts score at 3-to-4 months between the Kono-S procedure and the side-to-side functional end anastomosis.
- Secondary Outcome Measures
Name Time Method Secondary aim includes post-operative recurrence of Crohn’s disease using the Rutgeerts score at 12 months between the Kono-S procedure and the side-to-side functional end anastomosis, surgical recurrence rate at 60 months and time to surgical recurrence.