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Confusion in the Elderly After Colon Surgery

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01623297
Enrollment
52
Registered
2012-06-19
Start date
2012-01-31
Completion date
2015-01-31
Last updated
2012-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Phase Reaction, Confusion, Delirium, Inflammation, Surgery

Keywords

Laparoscopy, Surgery, Acute Phase Reaction, Aged, Aged 80 and over, Confusion, Inflammation, Delirium

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.

Interventions

None listed

Sponsors

New York State Department of Health
CollaboratorOTHER_GOV
New York Hospital Queens
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
65 Years to No maximum
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

Design outcomes

Primary

MeasureTime frameDescription
Confusion6 MonthsConfusion assessed by questionaires and cognitive testing

Secondary

MeasureTime frameDescription
degree of inflammation6 Months5 separate blood draws
presence of electrolyte imbalance6 months5 separate blood draws
pituitary-thyroid axis disruption6 months5 separate blood draws
liver function tests6 months5 separate blood draws
nutritional status6 months5 separate blood draws

Countries

United States

Contacts

Primary ContactMitchell Chorost, MD
mchorost@nyp.org718-670-1185
Backup ContactMitchell I Chorost, MD
mchorost@nyp.org718-670-1185

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026