A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 132
- Locations
- 2
- Primary Endpoint
- Grade of endoscopic recurrence
Study Overview
Brief Summary
Kono and collegues have described a new anastomotic technique to restore bowel contintuity after ileocecal resection for Crohn's disease (CD).
This tecnique implies a hand-sewn ileocolic anastomosis, that involves exclusively the antimesenteric side of the bowel and that functionally acts as an end-to-end anastomosis.
In a retrospective study, the authors have shown that this anastomotic tecnique, when compared to stapled side-to-side anastomosis, significantly reduces the severity of endoscopic recurrence at 1 year after surgery and the rate of reoperation for anastomotic recurrence at 5 years after surgery.
Aim of this trial is to compare the outcomes of the Kono anastomosis with the ones achieved by the stapled side-to-side anastomosis, within a prospective randomized study.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with Crohn's disease requiring ileocecal resection
Exclusion Criteria
- •age > 75 years
- •age < 18 years
- •inability to give the consent to the participation in the trial
- •refusal to participate in the trial after receiving accurate information
Outcomes
Primary Outcomes
Grade of endoscopic recurrence
Time Frame: 6 Months
Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery.
Surgical recurrence
Time Frame: Up to 5 years
Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery
Secondary Outcomes
- Surgical re-intervention(Up to 30 days)
- Recovery times(Participants will be followed for the duration of hospital stay, an expected average of 5 days)
- Endoscopic recurrence(6 months up to 5 years)
- Grade of endoscopic recurrence(6 months up to 5 years)
- Anastomotic leak(Up to 30 days)
- Postoperative morbidity rate(Up to 30 days)
- Anastomosis time(Intraoperatively)
- Clinical recurrence(Up to 5 years)
- Operating time(Intraoperatively)
Investigators
Luigi Bucci
Professor
Federico II University