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

NCT04623476 | Unknown DMC

• 1 other identifier: 112/20
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Crohn's Ileocolitis

Outcome Measures

Primary Outcomes (2)

• Rate of endoscopic CD recurrence

  Endoscopic Rutgeerts score \>1

  6 months

• Rate of endoscopic CD recurrence

  Endoscopic Rutgeerts score \>1

  12 months

Secondary Outcomes (8)

• Rate of overall postoperative complications

  30 days

• Rate of major postoperative complications

  30 days

• Overall and Disease specific Quality of life

  6 months

• Overall and Disease specific Quality of life

  6 months

• Overall and Disease specific Quality of life

  6 months

Study Arms (1)

Pathophysiological Excision for Chron's disease

EXPERIMENTAL

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

Procedure: Pathophysiological Excision for Crohn's disease

Interventions

Pathophysiological Excision for Crohn's disease PROCEDURE

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.

Also known as: PEC

Pathophysiological Excision for Chron's disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Policlinico Tor Vergata

Roma, RM, 00133, Italy

RECRUITING

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Giuseppe S Sica, MD, PhD

  Università di Roma Tor Vergata

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno Sensi, MD

CONTACT

3385352902; brunosensi@outlook.it

Giuseppe S Sica, MD, PhD

CONTACT

3385333659; sigisica@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, Head of Department

Model Details: Prospective pilot study

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 10, 2020
• Study Start: November 16, 2020
• Primary Completion: April 30, 2021
• Study Completion: April 30, 2021
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)