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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pathophysiological Excision for Chron's disease | Experimental | Consecutive patients (>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pathophysiological Excision for Crohn's disease | Procedure | 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. |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of overall postoperative complications | Clavien Dindo I-V | 30 days |
| Rate of major postoperative complications | Clavien Dindo III-V |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Bruno Sensi, MD | Contact | 3385352902 | brunosensi@outlook.it | |
| Giuseppe S Sica, MD, PhD | Contact | 3385333659 | sigisica@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Giuseppe S Sica, MD, PhD | Università di Roma Tor Vergata | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlinico Tor Vergata | Recruiting | Roma | RM | 00133 | Italy |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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Prospective pilot study
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|
|
| 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 |
| D007410 | Intestinal Diseases |