NCT02084524

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2013

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 4, 2013

Completed
4 months until next milestone

First Posted

Study publicly available on registry

March 12, 2014

Completed
2.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

October 5, 2016

Status Verified

October 1, 2016

Enrollment Period

Same day

First QC Date

November 4, 2013

Last Update Submit

October 4, 2016

Conditions

Keywords

vulnerablenutritioncancercolorectaltumor

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (7)

  • Malnutrition screening

    During preoperative seven days

  • Rate of preoperative nutritional management by immunonutrition implemented

    During preoperative seven days

  • Rate of malnourished patients

    During preoperative seven days

  • Rate of patients with cachexia

    Seventh day preoperative

  • Postoperative complications

    Postoperative follow-up until discharge from hospital, up to 30 days

  • +2 more secondary outcomes

Study Arms (1)

Nutritional evaluation

NO INTERVENTION
Procedure: Malnutrition screening and perioperative nutritional support

Interventions

* 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

Nutritional evaluation

Eligibility Criteria

Age70 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Aged ≥ 70 years
  • Colorectal or tumor resection with/without synchronous metastases

You may not qualify if:

  • Emergency resection of colorectal tumor
  • Unresectable colorectal tumor with/without synchronous metastases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Professeur Marc BONNEFOY

Pierre-Bénite, 69495, France

RECRUITING

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Colorectal NeoplasmsNeoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2013

First Posted

March 12, 2014

Study Start

October 1, 2013

Primary Completion

October 1, 2013

Study Completion

January 1, 2017

Last Updated

October 5, 2016

Record last verified: 2016-10

Locations