ClinicalTrials.Veeva

Menu

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

U

University Hospital, Lille

Status

Withdrawn

Conditions

Quality of Life

Treatments

Procedure: ileocecal resection
Drug: Anti TNF

Study type

Interventional

Funder types

Other

Identifiers

NCT02872506
2015_19
2016-A00019-42 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

0 participants in 2 patient groups

medical treatment by Anti TNF
Active Comparator group
Description:
The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time
Treatment:
Drug: Anti TNF
ileocecal resection
Active Comparator group
Description:
The surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy
Treatment:
Procedure: ileocecal resection

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems