Colorectal Tumor Clinical Trial
— ANC1Official 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.
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.
Status | Recruiting |
Enrollment | 150 |
Est. completion date | January 2017 |
Est. primary completion date | October 2013 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 70 Years and older |
Eligibility |
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 |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening
Country | Name | City | State |
---|---|---|---|
France | Professeur Marc BONNEFOY | Pierre Benite |
Lead Sponsor | Collaborator |
---|---|
Hospices Civils de Lyon |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perioperative nutritional management | Rate of nutritional support implemented in accordance with current European guidelines (ESPEN) | During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days | No |
Secondary | Malnutrition screening | Rate of malnutrition screening procedure | During preoperative seven days | No |
Secondary | Rate of preoperative nutritional management by immunonutrition implemented | Nutritional management by immunonutrition implemented is based on a complete nutritional evaluation | During preoperative seven days | No |
Secondary | Rate of malnourished patients | Rate of malnourished patients is defined by the ESPEN criteria | During preoperative seven days | No |
Secondary | Rate of patients with cachexia | Rate of patients with cachexia is defined by the French National Authority for Health (HAS) criteria | Seventh day preoperative | No |
Secondary | Postoperative complications | Rate and type of postoperative complications (Grade I, II et IIIa of Dindo classification) | Postoperative follow-up until discharge from hospital, up to 30 days | Yes |
Secondary | Rate of postoperative nutritional management implemented | Nutritional management implemented is based on the ESPEN guidelines | Postoperative follow-up until discharge from hospital, up to 30 days | No |
Secondary | Evolution of the activities of daily living | Variations of Activities of daily living (ADL) and Instrumental activities of daily living (IADL) scores | During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days | No |
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