Comparing Manual Versus Stapled Side to Side Ileocolic Anastomosis in Crohn's Disease

Study Overview
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Brief Summary
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RESEARCH QUESTION Are handsewn (end to end and Kono S side to side) anastomoses superior to side to side stapled anastomosis after ileocolic resection for Crohn's disease with respect to endoscopic recurrence, gastrointestinal function and costs. HYPOTHESIS Stapled side anastomosis advised in ECCO guidelines heal with ulcerations on the staple line causing systematic over scoring of endoscopic recurrence leading to unjustified restarting of expensive drugs reducing QOL and increasing costs. Side to side saccular configuration causes stasis affecting recurrence and dysfunction. DESIGN Randomised superiority study POPULATION Patients with Crohn requiring (re)resection of the (neo)terminal ileum INTERVENTION Kono S and end to end hand sewn anastomosis USUAL CARE Side to side stapled anastomosis OUTCOME Endoscopic recurrence (local and central reading) at 6 months SAMPLE 25% reduction in 2:1 ratio -> 126 + 63 = 189 patients KEYWORDS Crohn, ileocolic resection, recurrence

Official Title
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Rct in croHn's Disease: Comparing mANual (End to End and Kono-s) Versus stapleD Side TO Side Ileocolic Anastomosis (HANDTOEND)

Conditions
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Crohn Disease, IBD, Ileocolitis, Crohn's Ileocolitis

Intervention / Treatment
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* Procedure: Handsewn anastomosis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Males and females aged >18 years Ileocolic disease or disease of the neoterminal ileum with an indication for resection Concurrent therapies with corticosteroids, 5-ASA drugs, thiopurines, MTX, antibiotics, and anti-TNF therapy are permitted. All patients should have undergone a colonoscopy and MR enterography (or CT enterography if MR contraindicated) in last 3 months to assess extent of disease. Ability to comply with protocol. Competent and able to provide written informed consent. Patient must have been discussed in the local MDT Exclusion Criteria: Inability to give informed consent. Patients less than 16 years of age. Patients undergoing repeated ileocolic resection. History of cancer < 5 years which might influence patients prognosis Emergent operation. Pregnant or breast feeding.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 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
Interventional Model Description: Randomised superiority study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Handsewn ileocolic anastomosis<br>Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring | Procedure: Handsewn anastomosis<br>* To perform hand sewn anastomosis (either end to end or Kono-s) during the reconstruction face of ileocolic resection<br>|
| No Intervention: Side to side stapled anastomosis<br>Randomised comparison of handsewn (end-to-end and the Kono-S) with the side-to-side stapled anastomosis. to use a manual anastomosis technique avoiding stapled technique to verify if stapled anastomosis can cause ulcers at endoscopic follow up with systematic overscoring | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6 months endoscopic recurrence of endoscopy using the modified Rutgeerts classification. | The comparison of 6 months endoscopic recurrence between local and central reading of recordings of endoscopy using the modified Rutgeerts classification. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morbidity | postoperative morbidity measure | 1 year | 
| Clinical Recurrence | Clinical and surgical recurrence using Clavien Dindo | 1 year | 
| Inflammatory Bowel Disease Questionnaire (IBDQ) | Quality of life measured with IBD questionnaire | 1 year | 
| Hospital Costs | Hospital costs per patient in both groups | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IBD, Recurrence IBD, Endoscopic Recurrence, Rurgeers Score, Surgical recurrence, Crohn's Ileocolitis, Ileocolic Anastomosis, Crohn's disease