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

Not Applicable

• Conditions: Crohn's Ileocolitis; Crohn Disease
• Interventions: Procedure: Pathophysiological Excision for Crohn's disease

• Registration Number: NCT04623476
• Lead Sponsor: University of Rome Tor Vergata

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-09
• Study First Posted: 2020-11-10
• Study Start: 2020-11-16
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-24
• Last Update Posted: 2020-12-28
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Pathophysiological Excision for Chron's disease	Pathophysiological Excision for Crohn's disease	Consecutive patients (\>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD

Primary Outcome Measures

Name	Time	Method
Rate of endoscopic CD recurrence	12 months	Endoscopic Rutgeerts score \>1

Secondary Outcome Measures

Name	Time	Method
Overall and Disease specific Quality of life	12 months	Cleveland Global Quality of Life score (0-1 with higher scores representing better quality of life)
Rate of overall postoperative complications	30 days	Clavien Dindo I-V
Rate of major postoperative complications	30 days	Clavien Dindo III-V

Trial Locations

Locations (1)

Policlinico Tor Vergata; 🇮🇹 Roma, RM, Italy