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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02872506
Other study ID # 2015_19
Secondary ID 2016-A00019-42
Status Withdrawn
Phase N/A
First received
Last updated
Start date September 2017
Est. completion date August 2018

Study information

Verified date October 2018
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 2018
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Anti TNF
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.
Procedure:
ileocecal 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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Outcome

Type Measure Description Time frame Safety issue
Primary 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 at 6 months from the beginning of medical treatment or surgical resection
Secondary Inflammatory Bowel Disease Questionnaire (IBDQ) Inflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patient at baseline (beginning of medical treatment or surgical resection), at 6 months
Secondary Crohn's disease activity index (CDAI) at baseline, at 6 months
Secondary Length of small intestine segment resection Length of small intestine segment <10 cm 10 to 30 cm 30 to 50 cm at baseline
Secondary Duration of hospital stay at baseline
Secondary Clavien-Dindo classification of surgical complications at baseline, at 6 months
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