MedTrace Logo

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

NCT02872506 · Status: WITHDRAWN · Phase: NA · Type: INTERVENTIONAL

Last updated 2018-10-17

No results posted yet for this study

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.

Conditions

  • Quality of Life

Interventions

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.

Sponsors & Collaborators

  • University Hospital, Lille

    lead OTHER

Principal Investigators

  • Philippe Zerbib, MD, PhD · University Hospital, Lille

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-30
Primary Completion
2018-08-31
Completion
2018-08-31

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02872506 on ClinicalTrials.gov