Confusion in the Elderly After Colon Surgery
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ClinicalTrials.gov Identifier: NCT01623297 |
Recruitment Status : Unknown
Verified June 2012 by Mitchell Chorost, New York Hospital Queens.
Recruitment status was: Recruiting
First Posted : June 19, 2012
Last Update Posted : June 19, 2012
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Condition or disease |
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Confusion Inflammation Acute Phase Reaction Surgery Delirium |
Study Type : | Observational |
Estimated Enrollment : | 52 participants |
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? |
Study Start Date : | January 2012 |
Estimated Primary Completion Date : | January 2015 |
Estimated Study Completion Date : | January 2015 |
Group/Cohort |
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Laparoscopic colon surgery
Patients over age 65 having laparoscopic colon resection for colonic adenocarcinoma
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Open colon surgery
Patients over age 65 having open colon resection for colonic adenocarcinoma
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- Confusion [ Time Frame: 6 Months ]Confusion assessed by questionaires and cognitive testing
- 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

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
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

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
Contact: Mitchell Chorost, MD | 718-670-1185 | mchorost@nyp.org | |
Contact: Mitchell I Chorost, MD | 718-670-1185 | mchorost@nyp.org |
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 |
Principal Investigator: | Mitchell I Chorost, MD | New York Hospital Queens |
Responsible Party: | Mitchell Chorost, Principal Investigator, New York Hospital Queens |
ClinicalTrials.gov Identifier: | NCT01623297 |
Other Study ID Numbers: |
ECRIP |
First Posted: | June 19, 2012 Key Record Dates |
Last Update Posted: | June 19, 2012 |
Last Verified: | June 2012 |
Laparoscopy Surgery Acute Phase Reaction Aged |
Aged 80 and over Confusion Inflammation Delirium |
Delirium Confusion Inflammation Acute-Phase Reaction Pathologic Processes |
Neurobehavioral Manifestations Neurologic Manifestations Nervous System Diseases Neurocognitive Disorders Mental Disorders |