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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Withdrawn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
University Hospital, Lille
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    August 16, 2016
    Last Updated
    October 12, 2018
    Sponsor
    University Hospital, Lille
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    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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