Confusion in the Elderly After Colon Surgery

• Conditions: Confusion; Inflammation; Surgery; Acute Phase Reaction; Delirium

• Registration Number: NCT01623297
• Lead Sponsor: New York Hospital Queens

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-04-23
• Status Verified: 2012-06
• Study First Submitted QC: 2012-06-15
• Last Update Submitted: 2012-06-15
• Study First Posted: 2012-06-19
• Last Update Posted: 2012-06-19
• Primary Completion: 2015-01
• Study Completion: 2015-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 52

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Confusion	6 Months	Confusion assessed by questionaires and cognitive testing

Secondary Outcome Measures

Name	Time	Method
nutritional status	6 months	5 separate blood draws
degree of inflammation	6 Months	5 separate blood draws
pituitary-thyroid axis disruption	6 months	5 separate blood draws
presence of electrolyte imbalance	6 months	5 separate blood draws
liver function tests	6 months	5 separate blood draws

Trial Locations

Locations (1)

New York Hospital Queens; 🇺🇸 Flushing, New York, United States