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

U

University of Rome Tor Vergata

Status

Unknown

Conditions

Crohn's Ileocolitis
Crohn Disease

Treatments

Procedure: Pathophysiological Excision for Crohn's disease

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

12 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

12 participants in 1 patient group

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

Trial contacts and locations

1

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Central trial contact

Giuseppe S Sica, MD, PhD; Bruno Sensi, MD

Data sourced from clinicaltrials.gov

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