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Confusion in the Elderly After Colon Surgery

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Mitchell Chorost, New York Hospital Queens.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01623297
First Posted: June 19, 2012
Last Update Posted: June 19, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
New York State Department of Health
Information provided by (Responsible Party):
Mitchell Chorost, New York Hospital Queens
  Purpose
A study will be conducted to determine if there is any cognitive benefit in elderly patients having open versus minimally invasive colon cancer surgery.

Condition
Confusion Inflammation Acute Phase Reaction Surgery Delirium

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Cognitive Changes After Surgery in the Elderly: Does Minimally Invasive Surgery Influence the Incidence of Postoperative Cognitive Changes Compared to Open Colon Surgery?

Further study details as provided by Mitchell Chorost, New York Hospital Queens:

Primary Outcome Measures:
  • Confusion [ Time Frame: 6 Months ]
    Confusion assessed by questionaires and cognitive testing


Secondary Outcome Measures:
  • degree of inflammation [ Time Frame: 6 Months ]
    5 separate blood draws

  • presence of electrolyte imbalance [ Time Frame: 6 months ]
    5 separate blood draws

  • pituitary-thyroid axis disruption [ Time Frame: 6 months ]
    5 separate blood draws

  • liver function tests [ Time Frame: 6 months ]
    5 separate blood draws

  • nutritional status [ Time Frame: 6 months ]
    5 separate blood draws


Biospecimen Retention:   Samples Without DNA
Plasma samples stored up to 7 months then expired and discarded

Estimated Enrollment: 52
Study Start Date: January 2012
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: January 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Laparoscopic colon surgery
Patients over age 65 having laparoscopic colon resection for colonic adenocarcinoma
Open colon surgery
Patients over age 65 having open colon resection for colonic adenocarcinoma

Detailed Description:
Cognitive changes in the elderly are common after surgery. It is not known if minimally invasive or laparoscopic surgery can prevent these changes. A study will be conducted on patients scheduled to have abdominal surgery. The patients will have cognitive evaluations before and after surgery. A small amount of blood, about 2 tablespoons, will be collected no more than 5 times in 6 months. The results will be analyzed to determine if there are changes between those having open surgery versus patients having laparoscopic or minimally invasive surgery, and if these changes coincide with cognitive changes.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   65 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients newly diagnosed with colon adenocarcinoma will be contacted after being scheduled for surgery at New York Hospital Queens.
Criteria

Inclusion Criteria:

  • Patients over age 65.0 years and in need of elective colon resection for adenocarcinoma

Exclusion Criteria:

  • Inability to complete preoperative cognitive screening
  • Inability to complete study in English since CANTAB is timed and not validated with interpreters
  • Emergency surgery
  • Depression or psychiatric comorbidity
  • Pre-existing dementia
  • Previous cerebrovascular accident or "stroke"
  • Previous myocardial infarction
  • Cardiac ejection fraction below 55%
  • Propranolol, metoprolol or other betablocker use
  • Digoxin, procainamide, or amiodarone use
  • Calcium channel blocker use
  • History of vascular surgery or arterial vascular disease
  • History of alcohol dependence
  • Lovastatin or other HMG-CoA reductase inhibitor use
  • Ace inhibitor use
  • Neuroendocrine or catecholamine associated tumors
  • Hypertension
  • Diabetes
  • Benzodiazepine use
  • Dimenhydrinate or other medications to treat motion sickness
  • Metaclopramide use
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01623297


Contacts
Contact: Mitchell Chorost, MD 718-670-1185 mchorost@nyp.org
Contact: Mitchell I Chorost, MD 718-670-1185 mchorost@nyp.org

Locations
United States, New York
New York Hospital Queens Recruiting
Flushing, New York, United States, 11355
Contact: Mitchell I Chorost, MD    718-670-1185    mchorost@nyp.org   
Principal Investigator: Mitchell I Chorost, MD         
Sponsors and Collaborators
New York Hospital Queens
New York State Department of Health
Investigators
Principal Investigator: Mitchell I Chorost, MD New York Hospital Queens
  More Information

Publications:
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Redelmeier DA, Thiruchelvam D, Daneman N. Delirium after elective surgery among elderly patients taking statins. CMAJ. 2008 Sep 23;179(7):645-52. doi: 10.1503/cmaj.080443.
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Responsible Party: Mitchell Chorost, Principal Investigator, New York Hospital Queens
ClinicalTrials.gov Identifier: NCT01623297     History of Changes
Other Study ID Numbers: ECRIP
First Submitted: April 23, 2012
First Posted: June 19, 2012
Last Update Posted: June 19, 2012
Last Verified: June 2012

Keywords provided by Mitchell Chorost, New York Hospital Queens:
Laparoscopy
Surgery
Acute Phase Reaction
Aged
Aged 80 and over
Confusion
Inflammation
Delirium

Additional relevant MeSH terms:
Inflammation
Delirium
Confusion
Acute-Phase Reaction
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders


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