PAtophysiological, Nodal-based Approach for Crohn's Disease Excision

Study Overview
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Brief Summary
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Single centre prospective pilot study on surgery for Crohn's disease (CD). CD universally recurs after surgery and no technique so far has been proven to reduce recurrence. The investigators speculate that a different surgical technique, based on pathophysiology of the disease may prove successful in reducing rates of recurrence. Consecutive CD patients with a surgical indication for ileocolic disease will receive an extended procedure including a lymphadenectomy (Pathophysiologic excision for Crohn's disease). Primary outcome will be endoscopic recurrence rates at 6 and 12 months from surgery.

Official Title
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PAtophysiological, Nodal-based Approach for Crohn's Disease Excision: A PILOT Study

Conditions
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Crohn Disease, Crohn's Ileocolitis

Intervention / Treatment
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* Procedure: Pathophysiological Excision for Crohn's disease


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All consecutive patients undergoing surgery for ileocaecal/ileocolic CD in the Minimally Invasive Unit at Policlinico Tor Vergata are eligible to be enrolled. Informed consent Exclusion Criteria: Crohn's Disease with a different localisation Recurrent disease Extensive jejunitis <18 years of age Cancer as primary indication for surgery Followed by gastroenterologists outside our centre, due to loss of follow up Ileostomy. If a patient undergoes ileostomy fashioning he will be excluded from the study and this will be reported

Ages Eligible for Study
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Minimum Age: 18 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
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective pilot study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pathophysiological Excision for Chron's disease<br>Consecutive patients (>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD | Procedure: Pathophysiological Excision for Crohn's disease<br>* Pathophysiological excision for Crohn's (PEC) requires a medio-lateral approach and a high vascular tie, which enables excision of lymph nodes draining the disease bowel. This procedure should not alter length of bowel resection and no additional risks are foreseen. A latero-lateral anastomosis will be fashioned following current guidelines.<br>* Other names: PEC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of endoscopic CD recurrence | Endoscopic Rutgeerts score >1 | 6 months | 
| Rate of endoscopic CD recurrence | Endoscopic Rutgeerts score >1 | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of overall postoperative complications | Clavien Dindo I-V | 30 days | 
| Rate of major postoperative complications | Clavien Dindo III-V | 30 days | 
| Overall and Disease specific Quality of life | Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life) | 6 months | 
| Overall and Disease specific Quality of life | Inflammatory Bowel Disease-Control (Q 1-3 with higher scores representing better quality of life) | 6 months | 
| Overall and Disease specific Quality of life | Cleveland Global Quality of Life score (0-1 with with higher scores representing better quality of life) | 6 months | 
| Overall and Disease specific Quality of life | Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life) | 12 months | 
| Overall and Disease specific Quality of life | Inflammatory Bowel Disease-Control Q1-3 (0-18 with higher scores representing better quality of life) | 12 months | 
| Overall and Disease specific Quality of life | Cleveland Global Quality of Life score (0-1 with higher scores representing better quality of life) | 12 months |