Confusion in the Elderly After Colon Surgery

Surgery Clinical Trial

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?

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01623297
• Other study ID #: ECRIP
• Status: Recruiting
• Phase: N/A
• First received: April 23, 2012
• Last updated: June 15, 2012
• Start date: January 2012
• Est. completion date: January 2015

Study information

• Verified date: June 2012
• Source: New York Hospital Queens
• Contact: Mitchell Chorost, MD
• Phone: 718-670-1185
• Email: mchorost[@]nyp.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 52
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Phase Reaction
• Acute-Phase Reaction
• Confusion
• Delirium
• Inflammation
• Surgery

Locations

Country	Name	City	State
United States	New York Hospital Queens	Flushing	New York

Sponsors (2)

Lead Sponsor	Collaborator
New York Hospital Queens	New York State Department of Health

Country where clinical trial is conducted

United States, 

References & Publications (24)

Ansaloni L, Catena F, Chattat R, Fortuna D, Franceschi C, Mascitti P, Melotti RM. Risk factors and incidence of postoperative delirium in elderly patients after elective and emergency surgery. Br J Surg. 2010 Feb;97(2):273-80. doi: 10.1002/bjs.6843. — View Citation

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* Note: There are 24 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Confusion	Confusion assessed by questionaires and cognitive testing	6 Months	No
Secondary	degree of inflammation	5 separate blood draws	6 Months	No
Secondary	presence of electrolyte imbalance	5 separate blood draws	6 months	No
Secondary	pituitary-thyroid axis disruption	5 separate blood draws	6 months	No
Secondary	liver function tests	5 separate blood draws	6 months	No
Secondary	nutritional status	5 separate blood draws	6 months	No