Surgical Prevention of Anastomotic Recurrence by Excluding Mesentery in Crohn's Disease

Study Overview
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Brief Summary
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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.

Official Title
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A New Anastomotic Technique After Ileocecal Resection for Crohn's Disease. Kono-s Anastomosis vs Stapled Side-to-side Anastomosis: a Randomized Controlled Trial

Conditions
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Crohn Disease

Intervention / Treatment
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* Procedure: Kono anastomosis
* Procedure: Stapled side-to-side anastomosis


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Kono anastomosis<br>Patients receiving Kono anastomosis | Procedure: Kono anastomosis<br>* Kono anastomosis<br>|
| Experimental: Stapled side-to-side anastomosis<br>Patients receiving stapled side-to-side anastomosis | Procedure: Stapled side-to-side anastomosis<br>* Stapled side-to-side anastomosis<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of endoscopic recurrence | Severity of endoscopic recurrence (graded according to Rutgeerts' score) at the site of anastomosis at 6 months after surgery. | 6 Months | 
| Surgical recurrence | Rate of patients requiring resection for anastomotic recurrence within 5 years after surgery | Up to 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endoscopic recurrence | Presence of endoscopic recurrence | 6 months up to 5 years | 
| Grade of endoscopic recurrence | Severity of endoscopic recurrence at the site of anastomosis | 6 months up to 5 years | 
| Clinical recurrence | Presence of clinical recurrence (according to Crohn's disease activity index) | Up to 5 years | 
| Operating time | Duration of the operation (min) | Intraoperatively | 
| Anastomosis time | Time (min) required to perform the anastomosis | Intraoperatively | 
| Anastomotic leak | Incidence of anastomotic leak | Up to 30 days | 
| Surgical re-intervention | Rate of patients requiring surgical re-intervention | Up to 30 days | 
| Postoperative morbidity rate | Postoperative surgical (bleeding, obstruction, postoperative ileus, abdominal collection, wound infection) and medical morbidity as well as mortality will be documented and graded according to the Dindo Clavien classification | Up to 30 days | 
| Recovery times | Length of post-operative hospital stay, time to first flatus, time to first defecation, time to tolerance of liquid and solid diet will be documented | Participants will be followed for the duration of hospital stay, an expected average of 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn disease, ileocecal resection, anastomosis, Kono