Crohn Disease, Crohn's Ileocolitis
Conditions
Brief summary
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.
Interventions
PROCEDUREPathophysiological Excision for Crohn's disease
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.
Sponsors
University of Rome Tor Vergata
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Prospective pilot study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of endoscopic CD recurrence | 6 months | Endoscopic Rutgeerts score \>1 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of overall postoperative complications | 30 days | Clavien Dindo I-V |
| Rate of major postoperative complications | 30 days | Clavien Dindo III-V |
| Overall and Disease specific Quality of life | 6 months | Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life) |
Countries
Italy
Contacts
Primary ContactBruno Sensi, MD
Backup ContactGiuseppe S Sica, MD, PhD
Outcome results
None listed