Confusion in the Elderly After Colon Surgery

Sponsor
New York Hospital Queens (Other)
Overall Status
Unknown status
CT.gov ID
NCT01623297
Collaborator
New York State Department of Health (Other)
52
1
36
1.4

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated 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 :
    Jan 1, 2012
    Anticipated Primary Completion Date :
    Jan 1, 2015
    Anticipated Study Completion Date :
    Jan 1, 2015

    Arms and Interventions

    Arm Intervention/Treatment
    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

    Outcome Measures

    Primary Outcome Measures

    1. Confusion [6 Months]

      Confusion assessed by questionaires and cognitive testing

    Secondary Outcome Measures

    1. degree of inflammation [6 Months]

      5 separate blood draws

    2. presence of electrolyte imbalance [6 months]

      5 separate blood draws

    3. pituitary-thyroid axis disruption [6 months]

      5 separate blood draws

    4. liver function tests [6 months]

      5 separate blood draws

    5. nutritional status [6 months]

      5 separate blood draws

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    65 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 New York Hospital Queens Flushing New York United States 11355

    Sponsors and Collaborators

    • New York Hospital Queens
    • New York State Department of Health

    Investigators

    • Principal Investigator: Mitchell I Chorost, MD, New York Hospital Queens

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Mitchell Chorost, Principal Investigator, New York Hospital Queens
    ClinicalTrials.gov Identifier:
    NCT01623297
    Other Study ID Numbers:
    • ECRIP
    First Posted:
    Jun 19, 2012
    Last Update Posted:
    Jun 19, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Mitchell Chorost, Principal Investigator, New York Hospital Queens
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jun 19, 2012