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

PAtophysiological, Nodal-based Approach for Crohn's Disease Excision: A PILOT Study

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.

Study Overview

• Status: Unknown
• Conditions: Crohn Disease; Crohn's Ileocolitis
• Intervention / Treatment: Procedure: Pathophysiological Excision for Crohn's disease

• Study Type: Interventional
• Enrollment (Anticipated): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • RM
    • Roma, RM, Italy, 00133
      • Recruiting
      • Policlinico Tor Vergata

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: 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

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.; Other Names: PEC

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of endoscopic CD recurrence	Endoscopic Rutgeerts score >1	6 months
Rate of endoscopic CD recurrence	Endoscopic Rutgeerts score >1	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of overall postoperative complications	Clavien Dindo I-V	30 days
Rate of major postoperative complications	Clavien Dindo III-V	30 days
Overall and Disease specific Quality of life	Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)	6 months
Overall and Disease specific Quality of life	Inflammatory Bowel Disease-Control (Q 1-3 with higher scores representing better quality of life)	6 months
Overall and Disease specific Quality of life	Cleveland Global Quality of Life score (0-1 with with higher scores representing better quality of life)	6 months
Overall and Disease specific Quality of life	Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)	12 months
Overall and Disease specific Quality of life	Inflammatory Bowel Disease-Control Q1-3 (0-18 with higher scores representing better quality of life)	12 months
Overall and Disease specific Quality of life	Cleveland Global Quality of Life score (0-1 with higher scores representing better quality of life)	12 months

Collaborators and Investigators

• Sponsor: University of Rome Tor Vergata
• Investigators: Principal Investigator: Giuseppe S Sica, MD, PhD, Universita Di Roma Tor Vergata

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 16, 2020
• Primary Completion (ANTICIPATED): April 30, 2021
• Study Completion (ANTICIPATED): April 30, 2021

Study Registration Dates

• First Submitted: October 29, 2020
• First Submitted That Met QC Criteria: November 9, 2020
• First Posted (ACTUAL): November 10, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Crohn Disease
• Other Study ID Numbers: 112/20

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No