Skip to main content
Clinical Trials/NCT01623297
NCT01623297
Unknown
N/A

Cognitive Changes After Surgery in the Elderly: Does Minimally Invasive Surgery Influence the Incidence of Postoperative Cognitive Changes Compared to Open Colon Surgery?

New York Hospital Queens1 site in 1 country52 target enrollmentJanuary 2012

Overview

Phase
N/A
Intervention
Not specified
Conditions
Confusion
Sponsor
New York Hospital Queens
Enrollment
52
Locations
1
Primary Endpoint
Confusion
Last Updated
13 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2012
End Date
January 2015
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mitchell Chorost

Principal Investigator

New York Hospital Queens

Eligibility 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

Outcomes

Primary Outcomes

Confusion

Time Frame: 6 Months

Confusion assessed by questionaires and cognitive testing

Secondary Outcomes

  • nutritional status(6 months)
  • degree of inflammation(6 Months)
  • pituitary-thyroid axis disruption(6 months)
  • presence of electrolyte imbalance(6 months)
  • liver function tests(6 months)

Study Sites (1)

Loading locations...

Similar Trials