Trial record 18 of 2990 for:    Open Studies | "General Surgery"

Confusion in the Elderly After Colon Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2012 by New York Hospital Queens
Sponsor:
Collaborator:
New York State Department of Health
Information provided by (Responsible Party):
Mitchell Chorost, New York Hospital Queens
ClinicalTrials.gov Identifier:
NCT01623297
First received: April 23, 2012
Last updated: June 15, 2012
Last verified: June 2012
  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:


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
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

Publications:

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:
Acute-Phase Reaction
Confusion
Delirium
Inflammation
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on July 22, 2014