NCT02872506

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: University Hospital, Lille · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Quality of Life

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2017-09-01
• Primary completion: 2018-08-01
• Completion: 2018-08-01
• First posted: 2016-08-19
• Last updated: 2018-10-17