Quality of LifeCASINONCT02872506
Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
A study testing Anti TNF and ileocecal resection in people with Quality of Life, run by University Hospital, Lille.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Quality of Life
- What is being tested?
- Anti TNF and ileocecal resection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2017to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
About this study
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.
Read the 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
- Being tested
- Anti TNF, ileocecal resection
- Keywords
- Quality of life, Crohn's disease, Ileocecal resection, Anti TNF
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
ileocecal resectionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| medical treatment by Anti TNF | Active comparator | The medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time Receives: 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 Receives: Procedure: ileocecal resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at 6 months from the beginning of medical treatment or surgical resection
Secondary outcomes (5)
Inflammatory Bowel Disease Questionnaire (IBDQ)
Inflammatory Bowel Disease Questionnaire (IBDQ) at 6 months between 2 populations of patient
Measured: at baseline (beginning of medical treatment or surgical resection), at 6 months
Crohn's disease activity index (CDAI)
Measured: at baseline, at 6 months
Length of small intestine segment resection
Length of small intestine segment <10 cm 10 to 30 cm 30 to 50 cm
Measured: at baseline
Duration of hospital stay
Measured: at baseline
Clavien-Dindo classification of surgical complications
Measured: at baseline, at 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startSep 2017 (estimated)
- Primary completionAug 2018 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: investigator decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Quality of LifeStudies of the same condition, open and under way.
- More trials run by University Hospital, LilleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Lille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Philippe Zerbib, MD, PhD, Principal investigator, University Hospital, Lille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872506
- Sponsor's protocol ID
- 2015_19
- Other IDs
- 2016-A00019-42
- Acronym
- CASINO
- Status last verified
- Oct 2018
- First submitted
- 16 Aug 2016
- Last updated
- 17 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Quality of Life of Terminal Ileitis Patients With Crohn's Disease Treated With Anti-TNF or Surgical Resection
- ClinicalTrials.gov ID
- NCT02872506
- Acronym / sponsor ID
- CASINO / 2015_19
- Conditions
- Quality of Life
- Keywords
- Quality of life, Crohn's disease, Ileocecal resection, Anti TNF
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: investigator decision
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University Hospital, LilleUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| medical treatment by Anti TNF | Active comparator | Drug: Anti TNFThe medical treatment group will be chosen among patients receiving anti-TNF therapy for the first time |
| ileocecal resection | Active comparator | Procedure: ileocecal resectionThe surgical treatment group are the patients operated on for the first time by means of ileocecal resection laparoscopic or laparotomy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anti TNFPatients 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. | Drug | medical treatment by Anti TNF |
| ileocecal resectionThe 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. | Procedure or surgery | ileocecal resection |
Primary outcome
quality of life (QoL) by Inflammatory Bowel Disease Questionnaire
Time frame: at 6 months from the beginning of medical treatment or surgical resection
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
5 secondary outcomes
Inflammatory Bowel Disease Questionnaire (IBDQ)
Time frame: at baseline (beginning of medical treatment or surgical resection), at 6 months
Crohn's disease activity index (CDAI)
Time frame: at baseline, at 6 months
Length of small intestine segment resection
Time frame: at baseline
Duration of hospital stay
Time frame: at baseline
Clavien-Dindo classification of surgical complications
Time frame: at baseline, at 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philippe Zerbib, MD, PhD principal investigator
University Hospital, Lille
Questions about this trial
What is this clinical trial studying?
A study testing Anti TNF and ileocecal resection in people with Quality of Life, run by University Hospital, Lille.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 17 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
quality of life (QoL) by Inflammatory Bowel Disease Questionnaire (time frame: at 6 months from the beginning of medical treatment or surgical resection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2018.