Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection (CASINO)
Primary Purpose
Quality of Life
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Anti TNF
ileocecal resection
Sponsored by
About this trial
This is an interventional other trial for Quality of Life focused on measuring Quality of life, Crohn's disease, Ileocecal resection, Anti TNF
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
medical treatment by Anti TNF
ileocecal resection
Arm Description
The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time
The surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Inflammatory Bowel Disease Questionnaire (IBDQ)
Inflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patient
Crohn's disease activity index (CDAI)
Length of small intestine segment resection
Length of small intestine segment <10 cm 10 to 30 cm 30 to 50 cm
Duration of hospital stay
Clavien-Dindo classification of surgical complications
Full Information
NCT ID
NCT02872506
First Posted
August 16, 2016
Last Updated
October 12, 2018
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT02872506
Brief Title
Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
Acronym
CASINO
Official Title
Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Withdrawn
Why Stopped
investigator decision
Study Start Date
September 2017 (Anticipated)
Primary Completion Date
August 2018 (Anticipated)
Study Completion Date
August 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Quality of Life
Keywords
Quality of life, Crohn's disease, Ileocecal resection, Anti TNF
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medical treatment by Anti TNF
Arm Type
Active Comparator
Arm Description
The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time
Arm Title
ileocecal resection
Arm Type
Active Comparator
Arm Description
The surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy
Intervention Type
Drug
Intervention Name(s)
Anti TNF
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
ileocecal resection
Intervention Description
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.
Primary Outcome Measure Information:
Title
quality of life (QoL) by Inflammatory Bowel Disease Questionnaire
Description
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
Time Frame
at 6 months from the beginning of medical treatment or surgical resection
Secondary Outcome Measure Information:
Title
Inflammatory Bowel Disease Questionnaire (IBDQ)
Description
Inflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patient
Time Frame
at baseline (beginning of medical treatment or surgical resection), at 6 months
Title
Crohn's disease activity index (CDAI)
Time Frame
at baseline, at 6 months
Title
Length of small intestine segment resection
Description
Length of small intestine segment <10 cm 10 to 30 cm 30 to 50 cm
Time Frame
at baseline
Title
Duration of hospital stay
Time Frame
at baseline
Title
Clavien-Dindo classification of surgical complications
Time Frame
at baseline, at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philippe Zerbib, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
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