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

NCT04623476 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2020-12-28

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • University of Rome Tor Vergata

    lead OTHER

Principal Investigators

  • Giuseppe S Sica, MD, PhD · Università di Roma Tor Vergata

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-11-16
Primary Completion
2021-04-30
Completion
2021-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04623476 on ClinicalTrials.gov