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

Crohn Disease Clinical Trial

— PANACEAPILOT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04623476
• Other study ID #: 112/20
• Status: Recruiting
• Phase: N/A
• Start date: November 16, 2020
• Est. completion date: April 30, 2021

Study information

• Verified date: December 2020
• Source: University of Rome Tor Vergata
• Contact: Bruno Sensi, MD
• Phone: 3385352902
• Email: brunosensi[@]outlook.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: April 30, 2021
• Est. primary completion date: April 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Ileocolitis

Intervention

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.

Locations

Country	Name	City	State
Italy	Policlinico Tor Vergata	Roma	RM

Sponsors (1)

Lead Sponsor	Collaborator
University of Rome Tor Vergata

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of endoscopic CD recurrence	Endoscopic Rutgeerts score >1	6 months
Primary	Rate of endoscopic CD recurrence	Endoscopic Rutgeerts score >1	12 months
Secondary	Rate of overall postoperative complications	Clavien Dindo I-V	30 days
Secondary	Rate of major postoperative complications	Clavien Dindo III-V	30 days
Secondary	Overall and Disease specific Quality of life	Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)	6 months
Secondary	Overall and Disease specific Quality of life	Inflammatory Bowel Disease-Control (Q 1-3 with higher scores representing better quality of life)	6 months
Secondary	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
Secondary	Overall and Disease specific Quality of life	Inflammatory Bowel Disease Questionnaire (32 to 224 with higher scores representing better quality of life)	12 months
Secondary	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
Secondary	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