ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.

Colorectal Tumor Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02084524
• Other study ID #: 2011.703
• Status: Recruiting
• Phase: N/A
• First received: November 4, 2013
• Last updated: October 4, 2016
• Start date: October 2013
• Est. completion date: January 2017

Study information

• Verified date: October 2016
• Source: Hospices Civils de Lyon
• Contact: Marc BONNEFOY, PHD
• Phone: +33 4 788 615 81
• Email: marc.bonnefoy[@]chu-lyon.fr
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• 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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Colorectal Neoplasms
• Colorectal Tumor
• Malnutrition

Intervention

Procedure:
• Malnutrition screening and perioperative nutritional support
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

Locations

Country	Name	City	State
France	Professeur Marc BONNEFOY	Pierre Benite

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Country where clinical trial is conducted

France, 

Outcome

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