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

University of Rome Tor Vergata12 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Crohn Disease Crohn's Ileocolitis

Interventions

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Rate of endoscopic CD recurrence

Endoscopic Rutgeerts score \>1

Time frame: 6 months

Rate of endoscopic CD recurrence

Endoscopic Rutgeerts score \>1

Time frame: 12 months

Secondary Outcomes

Rate of overall postoperative complications

Clavien Dindo I-V

Time frame: 30 days

Rate of major postoperative complications

Clavien Dindo III-V

Time frame: 30 days