ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery. (ANC1)
Primary Purpose
Colorectal Tumor
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Malnutrition screening and perioperative nutritional support
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Tumor focused on measuring vulnerable, nutrition, cancer, colorectal, tumor
Eligibility Criteria
Inclusion Criteria:
- Aged ≥ 70 years
- Colorectal or tumor resection with/without synchronous metastases
Exclusion Criteria:
- Emergency resection of colorectal tumor
- Unresectable colorectal tumor with/without synchronous metastases
Sites / Locations
- Professeur Marc BONNEFOYRecruiting
Arms of the Study
Arm 1
Arm Type
No Intervention
Arm Label
Nutritional evaluation
Arm Description
Outcomes
Primary Outcome Measures
Perioperative nutritional management
Rate of nutritional support implemented in accordance with current European guidelines (ESPEN)
Secondary Outcome Measures
Malnutrition screening
Rate of malnutrition screening procedure
Rate of preoperative nutritional management by immunonutrition implemented
Nutritional management by immunonutrition implemented is based on a complete nutritional evaluation
Rate of malnourished patients
Rate of malnourished patients is defined by the ESPEN criteria
Rate of patients with cachexia
Rate of patients with cachexia is defined by the French National Authority for Health (HAS) criteria
Postoperative complications
Rate and type of postoperative complications (Grade I, II et IIIa of Dindo classification)
Rate of postoperative nutritional management implemented
Nutritional management implemented is based on the ESPEN guidelines
Evolution of the activities of daily living
Variations of Activities of daily living (ADL) and Instrumental activities of daily living (IADL) scores
Full Information
NCT ID
NCT02084524
First Posted
November 4, 2013
Last Updated
October 4, 2016
Sponsor
Hospices Civils de Lyon
1. Study Identification
Unique Protocol Identification Number
NCT02084524
Brief Title
ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.
Acronym
ANC1
Official Title
ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2013 (undefined)
Primary Completion Date
October 2013 (Actual)
Study Completion Date
January 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospices Civils de Lyon
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Malnutrition priori a major abdominal surgery is frequent and increases morbidity and mortality. The management of malnutrition has an impact in reducing postoperative complications. However malnutrition is rarely detected and Guidelines infrequently followed.
Recovery time and nutritional evaluation in elderly patients are major criteria in their postoperative management. Identifying malnutrition or malnutrition risk is fundamental to its treatment. It is therefore unsurprising that many validated tools for nutrition risk screening and nutrition assessment exist for the clinician to use in assisting with the accurate identification, referral and treatment of patients who are malnourished or at risk of malnutrition.
And nutritional management must be adapted and based on this evaluation and evolution of the general status (Guidelines Grade A).
A geriatric evaluation based on a screening of preoperative malnutrition should allow a better implementation of the European Society of Parenteral and Enteral Nutrition (ESPEN) guidelines.
Detailed Description
Assessing the impact of a geriatric action (Team Mobile Geriatrics, EMG, or if the geriatric facility team when it does not have EMG) on the rate of nutritional support perioperative elderly subjects (≥ 70 years) who underwent a colorectal cancer according to ESPEN recommendations and SFNEP.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Tumor
Keywords
vulnerable, nutrition, cancer, colorectal, tumor
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Nutritional evaluation
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Malnutrition screening and perioperative nutritional support
Intervention Description
Multidisciplinary training sessions for malnutrition and malnutrition risk screening, postoperative nutritional procedures according to the ESPEN Guidelines
Preoperative Geriatric evaluation : eligibility criteria, nutritional status, previous history, comorbidities, clinical examination, activities of daily living (ADL) and Instrumental activities of daily living (IADL)
Implementation of an adapted nutritional support based on ESPEN Guidelines
Primary Outcome Measure Information:
Title
Perioperative nutritional management
Description
Rate of nutritional support implemented in accordance with current European guidelines (ESPEN)
Time Frame
During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days
Secondary Outcome Measure Information:
Title
Malnutrition screening
Description
Rate of malnutrition screening procedure
Time Frame
During preoperative seven days
Title
Rate of preoperative nutritional management by immunonutrition implemented
Description
Nutritional management by immunonutrition implemented is based on a complete nutritional evaluation
Time Frame
During preoperative seven days
Title
Rate of malnourished patients
Description
Rate of malnourished patients is defined by the ESPEN criteria
Time Frame
During preoperative seven days
Title
Rate of patients with cachexia
Description
Rate of patients with cachexia is defined by the French National Authority for Health (HAS) criteria
Time Frame
Seventh day preoperative
Title
Postoperative complications
Description
Rate and type of postoperative complications (Grade I, II et IIIa of Dindo classification)
Time Frame
Postoperative follow-up until discharge from hospital, up to 30 days
Title
Rate of postoperative nutritional management implemented
Description
Nutritional management implemented is based on the ESPEN guidelines
Time Frame
Postoperative follow-up until discharge from hospital, up to 30 days
Title
Evolution of the activities of daily living
Description
Variations of Activities of daily living (ADL) and Instrumental activities of daily living (IADL) scores
Time Frame
During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged ≥ 70 years
Colorectal or tumor resection with/without synchronous metastases
Exclusion Criteria:
Emergency resection of colorectal tumor
Unresectable colorectal tumor with/without synchronous metastases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Marc BONNEFOY, PHD
Phone
+33 4 788 615 81
Email
marc.bonnefoy@chu-lyon.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Laurent VILLENEUVE
Phone
+33 4 788 645 36
Email
laurent.villeneuve@chu-lyon.fr
Facility Information:
Facility Name
Professeur Marc BONNEFOY
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurent VILLENEUVE
Phone
04 788 645 36
Email
laurent.villeneuve@chu-lyon.fr
12. IPD Sharing Statement
Citations:
PubMed Identifier
28061830
Citation
Dupuis M, Kuczewski E, Villeneuve L, Bin-Dorel S, Haine M, Falandry C, Gilbert T, Passot G, Glehen O, Bonnefoy M. Age Nutrition Chirugie (ANC) study: impact of a geriatric intervention on the screening and management of undernutrition in elderly patients operated on for colon cancer, a stepped wedge controlled trial. BMC Geriatr. 2017 Jan 7;17(1):10. doi: 10.1186/s12877-016-0402-3.
Results Reference
derived
Learn more about this trial
ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.
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