Confusion in the Elderly After Colon Surgery - Full Text View

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?

Resource links provided by NLM:

MedlinePlus related topics: Delirium

U.S. FDA Resources

Further study details as provided by New York Hospital Queens:

Primary Outcome Measures:

Confusion [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
Confusion assessed by questionaires and cognitive testing

Secondary Outcome Measures:

degree of inflammation [ Time Frame: 6 Months ] [ Designated as safety issue: No ]
5 separate blood draws
presence of electrolyte imbalance [ Time Frame: 6 months ] [ Designated as safety issue: No ]
5 separate blood draws
pituitary-thyroid axis disruption [ Time Frame: 6 months ] [ Designated as safety issue: No ]
5 separate blood draws
liver function tests [ Time Frame: 6 months ] [ Designated as safety issue: No ]
5 separate blood draws
nutritional status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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


Ages Eligible for Study:	65 Years and older (Adult, Senior)
Genders Eligible for Study:	Both
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

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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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Dasgupta M, Dumbrell AC. Preoperative risk assessment for delirium after noncardiac surgery: a systematic review. J Am Geriatr Soc. 2006 Oct;54(10):1578-89. Review.

Marcantonio ER, Goldman L, Mangione CM, Ludwig LE, Muraca B, Haslauer CM, Donaldson MC, Whittemore AD, Sugarbaker DJ, Poss R, et al. A clinical prediction rule for delirium after elective noncardiac surgery. JAMA. 1994 Jan 12;271(2):134-9.

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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Dubois MJ, Bergeron N, Dumont M, Dial S, Skrobik Y. Delirium in an intensive care unit: a study of risk factors. Intensive Care Med. 2001 Aug;27(8):1297-304.

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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
Study First Received:	April 23, 2012
Last Updated:	June 15, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on September 26, 2016