Confusion in the Elderly After Colon Surgery

NCT ID: NCT01623297

Last Updated: 2012-06-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

52 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-01-31

Study Completion Date

2015-01-31

Brief Summary

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A study will be conducted to determine if there is any cognitive benefit in elderly patients having open versus minimally invasive colon cancer surgery.

Detailed Description

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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.

Conditions

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Confusion Inflammation Acute Phase Reaction Surgery Delirium

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic colon surgery

Patients over age 65 having laparoscopic colon resection for colonic adenocarcinoma

No interventions assigned to this group

Open colon surgery

Patients over age 65 having open colon resection for colonic adenocarcinoma

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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New York State Department of Health

OTHER_GOV

Sponsor Role collaborator

New York Hospital Queens

OTHER

Sponsor Role lead

Responsible Party

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Mitchell Chorost

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mitchell I Chorost, MD

Role: PRINCIPAL_INVESTIGATOR

New York Hospital Queens

Locations

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New York Hospital Queens

Flushing, New York, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mitchell Chorost, MD

Role: CONTACT

718-670-1185

Mitchell I Chorost, MD

Role: CONTACT

718-670-1185

Facility Contacts

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Mitchell I Chorost, MD

Role: primary

718-670-1185

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Other Identifiers

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ECRIP

Identifier Type: -

Identifier Source: org_study_id

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