Colorectal TumorANC1NCT02084524
ANC1 Study Impact of a Geriatric and Nutritional Evaluation for the Malnutrition and Malnutrition Risk Screening in Patients Over 70 Years With Colorectal Surgery.
A study testing Malnutrition screening and perioperative nutritional support in people with Colorectal Tumor, run by Hospices Civils de Lyon at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- Colorectal Tumor
- What is being tested?
- Malnutrition screening and perioperative nutritional support
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2013to Jan 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Aged ≥ 70 years
- Colorectal or tumor resection with/without synchronous metastases
Who cannot join
- Emergency resection of colorectal tumor
- Unresectable colorectal tumor with/without synchronous metastases
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Professeur Marc BONNEFOY
Pierre-Bénite, 69495
Laurent VILLENEUVE, 04 788 645 36, laurent.villeneuve@chu-lyon.fr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Colorectal Tumor
- Being tested
- Malnutrition screening and perioperative nutritional support
- Keywords
- vulnerable, nutrition, cancer, colorectal, tumor
- Medical subject headings
- Colorectal Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Malnutrition screening and perioperative nutritional supportProcedure or surgery
- 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
| Study group | Role | What they receive |
|---|---|---|
| Nutritional evaluation | No intervention | Not described Receives: Procedure: Malnutrition screening and perioperative nutritional support |
What is being measured
The primary outcome is the main question the study is designed to answer.
Perioperative nutritional management
Rate of nutritional support implemented in accordance with current European guidelines (ESPEN)
Measured: During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days
Secondary outcomes (7)
Malnutrition screening
Rate of malnutrition screening procedure
Measured: During preoperative seven days
Rate of preoperative nutritional management by immunonutrition implemented
Nutritional management by immunonutrition implemented is based on a complete nutritional evaluation
Measured: During preoperative seven days
Rate of malnourished patients
Rate of malnourished patients is defined by the ESPEN criteria
Measured: During preoperative seven days
Rate of patients with cachexia
Rate of patients with cachexia is defined by the French National Authority for Health (HAS) criteria
Measured: Seventh day preoperative
Postoperative complications
Rate and type of postoperative complications (Grade I, II et IIIa of Dindo classification)
Measured: Postoperative follow-up until discharge from hospital, up to 30 days
Rate of postoperative nutritional management implemented
Nutritional management implemented is based on the ESPEN guidelines
Measured: Postoperative follow-up until discharge from hospital, up to 30 days
Evolution of the activities of daily living
Variations of Activities of daily living (ADL) and Instrumental activities of daily living (IADL) scores
Measured: During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2014 (estimated)
- Study startOct 2013
- Primary completionOct 2013
- Study completionJan 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Colorectal TumorStudies of the same condition, open and under way.
- More trials run by Hospices Civils de LyonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospices Civils de Lyon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02084524
- Sponsor's protocol ID
- 2011.703
- Acronym
- ANC1
- Status last verified
- Oct 2016
- First submitted
- 4 Nov 2013
- Last updated
- 5 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28061830
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT02084524
- Acronym / sponsor ID
- ANC1 / 2011.703
- Conditions
- Colorectal Tumor
- Keywords
- vulnerable, nutrition, cancer, colorectal, tumor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hospices Civils de LyonUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Oct 2013 (actual)
- Study completion
- Jan 2017 (estimated)
- First posted
- 12 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nutritional evaluation | No intervention | Procedure: Malnutrition screening and perioperative nutritional support |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (2 listed)
- Aged ≥ 70 years
- Colorectal or tumor resection with/without synchronous metastases
Key exclusion criteria (2 listed)
- Emergency resection of colorectal tumor
- Unresectable colorectal tumor with/without synchronous metastases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Procedure or surgery | Nutritional evaluation |
Primary outcome
Perioperative nutritional management
Time frame: 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)
7 secondary outcomes
Malnutrition screening
Time frame: During preoperative seven days
Rate of preoperative nutritional management by immunonutrition implemented
Time frame: During preoperative seven days
Rate of malnourished patients
Time frame: During preoperative seven days
Rate of patients with cachexia
Time frame: Seventh day preoperative
Postoperative complications
Time frame: Postoperative follow-up until discharge from hospital, up to 30 days
Rate of postoperative nutritional management implemented
Time frame: Postoperative follow-up until discharge from hospital, up to 30 days
Evolution of the activities of daily living
Time frame: During preoperative seven days and postoperative follow-up until discharge from hospital, up to 30 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2016.
- Derived from this study: PubMed 28061830Dupuis 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Malnutrition screening and perioperative nutritional support in people with Colorectal Tumor, run by Hospices Civils de Lyon at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marc BONNEFOY, PHD (+33 4 788 615 81, marc.bonnefoy@chu-lyon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Perioperative nutritional management (time frame: During perioperative period From D-7 before date of hospitalization until discharge from the hospital, up to 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02084524, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2016.