An interventional study of Anti TNF and ileocecal resection in Quality of Life, sponsored by University Hospital, Lille. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-10-17.
Sponsored by University Hospital, Lille · Not applicable, Interventional, and Other
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.
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.
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Exclusion Criteria:
The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time
Drug: Anti TNF
The surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy
Procedure: ileocecal resection
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.
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.
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
Time frame: at 6 months from the beginning of medical treatment or surgical resection
Inflammatory Bowel Disease Questionnaire (IBDQ)
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
Crohn's disease activity index (CDAI)
Time frame: 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
Time frame: at baseline
Duration of hospital stay
Time frame: at baseline
Clavien-Dindo classification of surgical complications
Time frame: at baseline, at 6 months
No study locations are listed for this record.
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Sep 2017; primary completion for Aug 2018, 11 months later.
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This study is withdrawn, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.
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