NCT02872506

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.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2017

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 16, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 19, 2016

Completed
1 year until next milestone

Study Start

First participant enrolled

September 1, 2017

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

October 17, 2018

Status Verified

October 1, 2018

Enrollment Period

11 months

First QC Date

August 16, 2016

Last Update Submit

October 12, 2018

Conditions

Quality of Life

Keywords

Quality of lifeCrohn's diseaseIleocecal resectionAnti TNF

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Inflammatory Bowel Disease Questionnaire (IBDQ)

    at baseline (beginning of medical treatment or surgical resection), at 6 months

  • Crohn's disease activity index (CDAI)

    at baseline, at 6 months

  • Length of small intestine segment resection

    at baseline

  • Duration of hospital stay

    at baseline

  • Clavien-Dindo classification of surgical complications

    at baseline, at 6 months

Study Arms (2)

medical treatment by Anti TNF

ACTIVE COMPARATOR

The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time

Drug: Anti TNF

ileocecal resection

ACTIVE COMPARATOR

The surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy

Procedure: ileocecal resection

Interventions

Anti TNFDRUG

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.

medical treatment by Anti TNF
ileocecal resectionPROCEDURE

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.

ileocecal resection

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Prophylactic treatment of recurrence before endoscopic control at the 6th postoperative month.
  • Contraindication to Anti-TNF after the initial lap works.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crohn Disease

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Study Officials

  • Philippe Zerbib, MD, PhD

    University Hospital, Lille

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 16, 2016

First Posted

August 19, 2016

Study Start

September 1, 2017

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

October 17, 2018

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share