Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care | Active Comparator | 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 |
|
| Immunonutrition | Experimental | Impact |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Post-operative infective complications rate | 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 | 30 days post-operatively |
| 6 months endoscopic recurrence | 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). | 6 months post-operatively |
| Measure | Description | Time Frame |
|---|---|---|
| 6 months nutritional status | 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. | 6 months post-operatively |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Annalisa Maroli, PhD | Contact | +390282247776 | annalisa.maroli@humanitas.it | |
| Lara Monti, MS | Contact | +390282244623 | lara.monti@humanitas.it |
| Name | Affiliation | Role |
|---|---|---|
| Antonino Spinelli, MD, PhD | Istituto Clinico Humanitas | Principal Investigator |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D059039 | Standard of Care |
| D000093702 | Immunonutrition Diet |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Immunonutrition | Dietary Supplement | 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 |
|
| 30 days quality of life | 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). | 30 days post-operatively |
| 90 days quality of life | 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 post-operatively |
| 6 months quality of life | 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 post-operatively |
| D004032 | Diet |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |