PAtophysiological, Nodal-based Approach for Crohn's Disease Excision
NCT ID: NCT04623476
Last Updated: 2020-12-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
12 participants
INTERVENTIONAL
2020-11-16
2021-04-30
Brief Summary
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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
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pathophysiological Excision for Chron's disease
Consecutive patients (\>18 years old) with a surgical indication for ileocolic Crohn's disease, at their first operation for CD
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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University of Rome Tor Vergata
OTHER
Responsible Party
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Giuseppe Sigismondo Sica
Associate Professor, Head of Department
Principal Investigators
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Giuseppe S Sica, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Università di Roma Tor Vergata
Locations
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Policlinico Tor Vergata
Roma, RM, Italy
Countries
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Central Contacts
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Facility Contacts
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Bruno Sensi, MD
Role: primary
Giuseppe S Sica, MD, PhD
Role: backup
Other Identifiers
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112/20
Identifier Type: -
Identifier Source: org_study_id