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出境医 / 临床实验 / Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients (EPIRIC)

Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients (EPIRIC)

Study Description
Brief Summary:
This is an interventional randomized ope-label two-arm trial on the peri-operative use of immunonutrition in Crohn's Disease (CD) patients undergoing colorectal elective surgery.The aim of the trial is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence.

Condition or disease Intervention/treatment Phase
Crohn Disease Other: Standard of Care Dietary Supplement: Immunonutrition Not Applicable

Detailed Description:
Crohn's Disease (CD) patients undergoing abdominal surgery are at high risk to develop post-operative surgical and medical infective complications. Infective complications affect almost 24% of patients. Post-surgical disease recurrence afflicts 35-85% of CD patients in the first year after surgery. Immunonutrition has been successfully applied to surgical patients in several randomized trials, demonstrating a decreased rate of post-operative infective complications. The aim of the study is to compare the incidence of surgical and medical post-operative infective complications and six months endoscopic and clinical disease recurrence (DR) in CD patients receiving immunonutrition in the peri-operative setting compared to patients treated as for standard of care.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
Estimated Study Start Date : March 1, 2020
Estimated Primary Completion Date : March 1, 2022
Estimated Study Completion Date : October 1, 2022
Arms and Interventions
Arm Intervention/treatment
Active Comparator: Standard of Care
Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
Other: Standard of Care
Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist

Experimental: Immunonutrition
Impact
Dietary Supplement: Immunonutrition
Impact. Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days

Outcome Measures
Primary Outcome Measures :
  1. Post-operative infective complications rate [ Time Frame: 30 days post-operatively ]
    Post-operative infective complications rate (including intra-abdominal septic complications, surgical site infections and medical inflections) will be evaluated with clinical, radiological and molecular analysis

  2. 6 months endoscopic recurrence [ Time Frame: 6 months post-operatively ]
    Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score. Rutgeert score is an endoscopic risk score intended to predict disease recurrence: it is calculated depending on the number and type of intestinal lesions and consists of five level of disease recurrence risk, from 0 (endoscopic remission) to 4 (advanced disease recurrence).


Secondary Outcome Measures :
  1. 6 months nutritional status [ Time Frame: 6 months post-operatively ]
    Nutritional status will be evaluated through the Malnutrition Universal Screening Tool (MUST). MUST consists of three different levels, generating a risk predictor ranging from 0 (low risk) to 2 (high risk), considering the calculated Body Mass Index (BMI), the unintentional weight loss and the pathological conditions of the patient.

  2. 30 days quality of life [ Time Frame: 30 days post-operatively ]
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).

  3. 90 days quality of life [ Time Frame: 90 days post-operatively ]
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).

  4. 6 months quality of life [ Time Frame: 6 months post-operatively ]
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients > 18 years old, females or males;
  • Established Crohn's Disease at the time of surgery indication;
  • Patients scheduled for elective open or minimally invasive bowel resection or strictureplasty;
  • Patients planned for concomitant perianal surgery for CD-related perianal disease can be included in the study.

Exclusion Criteria:

  • Patients < 18 years old;
  • Pregnant or breastfeeding women;
  • Diagnosis of undetermined colitis;
  • Concomitant diagnosis of malignancy;
  • Established malnutrition, according to clinical definition, requiring nutritional intervention;
  • Patients with more than two criteria for high risk of recurrence among the following: previous abdominal resection, penetrating disease phenotype or active smoking;
  • Any condition that, in the opinion of the investigator, can interfere with the consent procedure or the conduction of the trial;
  • Patients known to have allergic history to any component of the investigational product;
  • Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal);
  • Patients diagnosed with diabetes or fasting blood glucose≥ 10mmol/L;
  • Planned recovery shorter than 48 hours;
  • Surgery in emergency setting;
  • Any concomitant surgery not related to CD or perianal CD.
Contacts and Locations

Contacts
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Contact: Annalisa Maroli, PhD +390282247776 annalisa.maroli@humanitas.it
Contact: Lara Monti, MS +390282244623 lara.monti@humanitas.it

Sponsors and Collaborators
Istituto Clinico Humanitas
Investigators
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Principal Investigator: Antonino Spinelli, MD, PhD Istituto Clinico Humanitas
Tracking Information
First Submitted Date  ICMJE July 8, 2019
First Posted Date  ICMJE July 10, 2019
Last Update Posted Date November 27, 2019
Estimated Study Start Date  ICMJE March 1, 2020
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • Post-operative infective complications rate [ Time Frame: 30 days post-operatively ]
    Post-operative infective complications rate (including intra-abdominal septic complications, surgical site infections and medical inflections) will be evaluated with clinical, radiological and molecular analysis
  • 6 months endoscopic recurrence [ Time Frame: 6 months post-operatively ]
    Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score. Rutgeert score is an endoscopic risk score intended to predict disease recurrence: it is calculated depending on the number and type of intestinal lesions and consists of five level of disease recurrence risk, from 0 (endoscopic remission) to 4 (advanced disease recurrence).
Original Primary Outcome Measures  ICMJE
 (submitted: July 8, 2019)
  • Post-operative infective complications rate [ Time Frame: 30 days post-operatively ]
    Post-operative infective complications rate (including intra-abdominal septic complications, surgical site infections and medical inflections) will be evaluated with clinical, radiological and molecular analysis
  • 6 months endoscopic recurrence [ Time Frame: 6 months post-operatively ]
    Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score.
  • 12 months endoscopic recurrence [ Time Frame: 12 months post-operatively ]
    Endoscopic recurrence will be evaluated through colonoscopy with or without biopsies and Rutgeert score.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 25, 2019)
  • 6 months nutritional status [ Time Frame: 6 months post-operatively ]
    Nutritional status will be evaluated through the Malnutrition Universal Screening Tool (MUST). MUST consists of three different levels, generating a risk predictor ranging from 0 (low risk) to 2 (high risk), considering the calculated Body Mass Index (BMI), the unintentional weight loss and the pathological conditions of the patient.
  • 30 days quality of life [ Time Frame: 30 days post-operatively ]
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
  • 90 days quality of life [ Time Frame: 90 days post-operatively ]
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
  • 6 months quality of life [ Time Frame: 6 months post-operatively ]
    Quality of Life will be evaluated trhough the Short-Inflammatory Bowel Disease Quality of Life questionnaire (S-IBDQoL), which is 10-item questionnaire. All items are reported in a 7 point scale, from "all of the time" to "none of the time" (1 = poor health; 7 = good health).
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
Official Title  ICMJE Effect of Peri-operative Immunonutrition on Recurrence and Infections in Crohn's Disease Patients
Brief Summary This is an interventional randomized ope-label two-arm trial on the peri-operative use of immunonutrition in Crohn's Disease (CD) patients undergoing colorectal elective surgery.The aim of the trial is to assess the effectiveness of immunonutrition therapy in decreasing the rate of post-operative infective complications and 6 months endoscopic disease recurrence.
Detailed Description Crohn's Disease (CD) patients undergoing abdominal surgery are at high risk to develop post-operative surgical and medical infective complications. Infective complications affect almost 24% of patients. Post-surgical disease recurrence afflicts 35-85% of CD patients in the first year after surgery. Immunonutrition has been successfully applied to surgical patients in several randomized trials, demonstrating a decreased rate of post-operative infective complications. The aim of the study is to compare the incidence of surgical and medical post-operative infective complications and six months endoscopic and clinical disease recurrence (DR) in CD patients receiving immunonutrition in the peri-operative setting compared to patients treated as for standard of care.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Crohn Disease
Intervention  ICMJE
  • Other: Standard of Care
    Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
  • Dietary Supplement: Immunonutrition
    Impact. Patients will be asked to consume 3 cartons/day of Nestle IMPACT for pre-operative 7 days and 1 carton/day of Nestle IMPACT for post-operative 30 days
Study Arms  ICMJE
  • Active Comparator: Standard of Care
    Standard of Care is represented by the best standard peri-operative treatment already planned for the study population: as for ERAS guidelines, it is represented by fast restoration of liquid and solid diet after surgery (approximately 24 hours after surgery) and pre-operative and post-operative dietary counselling whenever indicated by the surgeon or gastroenterologist
    Intervention: Other: Standard of Care
  • Experimental: Immunonutrition
    Impact
    Intervention: Dietary Supplement: Immunonutrition
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: July 8, 2019)
350
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 1, 2022
Estimated Primary Completion Date March 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients > 18 years old, females or males;
  • Established Crohn's Disease at the time of surgery indication;
  • Patients scheduled for elective open or minimally invasive bowel resection or strictureplasty;
  • Patients planned for concomitant perianal surgery for CD-related perianal disease can be included in the study.

Exclusion Criteria:

  • Patients < 18 years old;
  • Pregnant or breastfeeding women;
  • Diagnosis of undetermined colitis;
  • Concomitant diagnosis of malignancy;
  • Established malnutrition, according to clinical definition, requiring nutritional intervention;
  • Patients with more than two criteria for high risk of recurrence among the following: previous abdominal resection, penetrating disease phenotype or active smoking;
  • Any condition that, in the opinion of the investigator, can interfere with the consent procedure or the conduction of the trial;
  • Patients known to have allergic history to any component of the investigational product;
  • Patient with liver and kidney dysfunction (alanine aminotransferase ALT ≥ 2 times the upper limit of normal; total bilirubin TBIL ≥ 2 times the upper limit of normal; creatinine Cr ≥ 2 times the upper limit of normal);
  • Patients diagnosed with diabetes or fasting blood glucose≥ 10mmol/L;
  • Planned recovery shorter than 48 hours;
  • Surgery in emergency setting;
  • Any concomitant surgery not related to CD or perianal CD.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Annalisa Maroli, PhD +390282247776 annalisa.maroli@humanitas.it
Contact: Lara Monti, MS +390282244623 lara.monti@humanitas.it
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04014517
Other Study ID Numbers  ICMJE 2019-001
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Istituto Clinico Humanitas
Study Sponsor  ICMJE Istituto Clinico Humanitas
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Antonino Spinelli, MD, PhD Istituto Clinico Humanitas
PRS Account Istituto Clinico Humanitas
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP