Clinical Trial: Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection

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 Summary: 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.
Sponsor: University Hospital, Lille

Current Primary Outcome: Quality of life [ Time Frame: at 6 months from the beginning of medical treatment or surgical resection ]

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


Original Primary Outcome: Same as current

Current Secondary Outcome:

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


Original Secondary Outcome: Same as current

Information By: University Hospital, Lille

Dates:
Date Received: August 16, 2016
Date Started: March 2017
Date Completion: August 2018
Last Updated: February 20, 2017
Last Verified: February 2017