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

• Sponsor: Hospices Civils de Lyon (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT02084524
• Collaborator: (none)
• Enrollment: 150
• Location: 1
• Arm: 1
• Duration (Months): 39
• Patients Per Site Per Month: 3.8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Colorectal Tumor	Procedure: Malnutrition screening and perioperative nutritional support	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 150 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Screening
• 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 Start Date: Oct 1, 2013
• Actual Primary Completion Date: Oct 1, 2013
• Anticipated Study Completion Date: Jan 1, 2017

Arms and Interventions

Arm

Intervention/Treatment

No Intervention: Nutritional evaluation

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

Outcome Measures

Primary Outcome Measures

1. Perioperative nutritional management [During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days]

   Rate of nutritional support implemented in accordance with current European guidelines (ESPEN)

Secondary Outcome Measures

1. Malnutrition screening [During preoperative seven days]

   Rate of malnutrition screening procedure

2. Rate of preoperative nutritional management by immunonutrition implemented [During preoperative seven days]

   Nutritional management by immunonutrition implemented is based on a complete nutritional evaluation

3. Rate of malnourished patients [During preoperative seven days]

   Rate of malnourished patients is defined by the ESPEN criteria

4. Rate of patients with cachexia [Seventh day preoperative]

   Rate of patients with cachexia is defined by the French National Authority for Health (HAS) criteria

5. Postoperative complications [Postoperative follow-up until discharge from hospital, up to 30 days]

   Rate and type of postoperative complications (Grade I, II et IIIa of Dindo classification)

6. Rate of postoperative nutritional management implemented [Postoperative follow-up until discharge from hospital, up to 30 days]

   Nutritional management implemented is based on the ESPEN guidelines

7. Evolution of the activities of daily living [During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days]

   Variations of Activities of daily living (ADL) and Instrumental activities of daily living (IADL) scores

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Professeur Marc BONNEFOY	Pierre Benite		France	69495

Sponsors and Collaborators

• Hospices Civils de Lyon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hospices Civils de Lyon
• ClinicalTrials.gov Identifier: NCT02084524
• Other Study ID Numbers: 2011.703
• First Posted: Mar 12, 2014
• Last Update Posted: Oct 5, 2016
• Last Verified: Oct 1, 2016

• Keywords provided by Hospices Civils de Lyon: vulnerable; nutrition; cancer; colorectal; tumor
• Additional relevant MeSH terms: Colorectal Neoplasms; Malnutrition

Study Results

No Results Posted as of Oct 5, 2016