Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection (CASINO)

Compare the quality of life at 6 months between 2 populations of patients followed for terminal ileitis of Crohn's disease treated with anti-TNF or ileocecal resection.

Study Overview

• Status: Withdrawn
• Conditions: Quality of Life
• Intervention / Treatment: Drug: Anti TNF; Procedure: ileocecal resection

Detailed Description

Two groups of patients suffering from Crohn's terminal ileitis will be matched by sex, age (A2, A3), the time evolution of the disease, the length of the diseased ileal segment (less than 10 cm; 10 to 30; 30 to 50 cm) and the Montreal classification (B1, B2). The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time. The surgical group are the patients operated on for the first time by means of ileocecal resection by laparoscopy or laparotomy without any severity criteria or perianal lesions and do not require prophylactic treatment of recurrence.

• Study Type: Interventional
• Phase: Not Applicable

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:

• isolated Crohn's ileitis without history of bowel resection and never previously been treated with anti-TNF
• Men and woman over 18 years
• Patient with social security cover
• reapproved indication during multidisciplinary meeting
• Patient able to receive clear information in written and oral
• Informed consent signed by the patient

Exclusion Criteria:

• Prophylactic treatment of recurrence before endoscopic control at the 6th postoperative month.
• Contraindication to Anti-TNF after the initial lap works.
• The side effects of surgery or anti-TNF are not exclusion criteria.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: medical treatment by Anti TNF; The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time	Drug: Anti TNF; Patients are admitted to day hospital with blood test less than 7 days. In the absence of contraindications, hydrocortisone infusion 200 mg will be conducted for 15 minutes followed by anti-TNF treatment infusion over 2 hours for the first three sessions. The following infusions of anti-TNF therapy will be on the same terms without hydrocortisone, every 4 to 8 weeks, in doses of 5-10mg/kg. Adverse effect most frequently reported was URTI. The most serious adverse reactions, were a reactivation of hepatitis B, congestive heart failure, serious infection, serum hypersensitivity reactions, blood diseases, systemic lupus erythematosus / lupus-like syndrome, demyelinating disorders, hepatobiliary metabolism disorders. The QOL will be assessed by IBDQ score at the inclusion visit before the first infusion and at 6 months.
Active Comparator: ileocecal resection; The surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy	Procedure: ileocecal resection; The operation is performed by laparoscopy or laparotomy. Hospital stay is on average 6 days. Preparation for the intervention is sometimes required 3 weeks to 1 month before the procedure to avoid risk situations.The main risk of the intervention is the anastomotic fistula. This risk of anastomotic leakage mainly concerns malnourished patients operated within the context of abdominal sepsis (abscess). An assessment protocol of post-operative pain, every 3 hours, is now well codified in routine surgery. The QOL will be assessed by the IBDQ score before surgery and at 6 months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
quality of life (QoL) by Inflammatory Bowel Disease Questionnaire	comparing the quality of life (QoL) by Inflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patients followed for Crohn's terminal ileitis treated with anti-TNF or operated on by means of ileocecal resection	at 6 months from the beginning of medical treatment or surgical resection

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory Bowel Disease Questionnaire (IBDQ)	Inflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patient	at baseline (beginning of medical treatment or surgical resection), at 6 months
Crohn's disease activity index (CDAI)		at baseline, at 6 months
Length of small intestine segment resection	Length of small intestine segment <10 cm 10 to 30 cm 30 to 50 cm	at baseline
Duration of hospital stay		at baseline
Clavien-Dindo classification of surgical complications		at baseline, at 6 months

Collaborators and Investigators

• Sponsor: University Hospital, Lille
• Investigators: Principal Investigator: Philippe Zerbib, MD, PhD, University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2017
• Primary Completion (Anticipated): August 1, 2018
• Study Completion (Anticipated): August 1, 2018

Study Registration Dates

• First Submitted: August 16, 2016
• First Submitted That Met QC Criteria: August 18, 2016
• First Posted (Estimate): August 19, 2016

Study Record Updates

• Last Update Posted (Actual): October 17, 2018
• Last Update Submitted That Met QC Criteria: October 12, 2018
• Last Verified: October 1, 2018

More Information

Terms related to this study

• Keywords: Quality of life; Crohn's disease; Ileocecal resection; Anti TNF
• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Inflammatory Bowel Diseases; Enteritis; Ileal Diseases; Crohn Disease; Ileitis
• Other Study ID Numbers: 2015_19; 2016-A00019-42 (Other Identifier: ID-RCB number, ANSM)

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