NCT04623476

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: University of Rome Tor Vergata · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Crohn Disease
• Crohn's Ileocolitis

Interventions

Type	Name	Description
PROCEDURE	Pathophysiological 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.

Timeline

• Start date: 2020-11-16
• Primary completion: 2021-04-30
• Completion: 2021-04-30
• First posted: 2020-11-10
• Last updated: 2020-12-28

Locations

1 site across 1 country: Italy