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

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

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02872506
Acronym
CASINO
Enrollment
0
Registered
2016-08-19
Start date
2017-09-30
Completion date
2018-08-31
Last updated
2018-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Quality of Life

Keywords

Quality of life, Crohn's disease, Ileocecal resection, Anti TNF

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.

Interventions

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.

PROCEDUREileocecal 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.

Sponsors

University Hospital, Lille
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
quality of life (QoL) by Inflammatory Bowel Disease Questionnaireat 6 months from the beginning of medical treatment or surgical resectioncomparing 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

MeasureTime frameDescription
Inflammatory Bowel Disease Questionnaire (IBDQ)at baseline (beginning of medical treatment or surgical resection), at 6 monthsInflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patient
Crohn's disease activity index (CDAI)at baseline, at 6 months
Length of small intestine segment resectionat baselineLength of small intestine segment \<10 cm 10 to 30 cm 30 to 50 cm
Duration of hospital stayat baseline
Clavien-Dindo classification of surgical complicationsat baseline, at 6 months

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026