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?

A study will be conducted to determine if there is any cognitive benefit in elderly patients having open versus minimally invasive colon cancer surgery.

Study Overview

• Status: Unknown
• Conditions: Inflammation; Delirium; Confusion; Surgery; Acute Phase Reaction

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 Type: Observational
• Enrollment (Anticipated): 52

Contacts and Locations

• Study Contact: Name: Mitchell Chorost, MD; Phone Number: 718-670-1185; Email: mchorost@nyp.org
• Study Contact Backup: Name: Mitchell I Chorost, MD; Phone Number: 718-670-1185; Email: mchorost@nyp.org

Study Locations

• United States
  • New York
    • Flushing, New York, United States, 11355
      • Recruiting
      • New York Hospital Queens
      • Contact: Mitchell I Chorost, MD; Phone Number: 718-670-1185; Email: mchorost@nyp.org
      • Principal Investigator: Mitchell I Chorost, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confusion	Confusion assessed by questionaires and cognitive testing	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
degree of inflammation	5 separate blood draws	6 Months
presence of electrolyte imbalance	5 separate blood draws	6 months
pituitary-thyroid axis disruption	5 separate blood draws	6 months
liver function tests	5 separate blood draws	6 months
nutritional status	5 separate blood draws	6 months

Collaborators and Investigators

• Sponsor: New York Hospital Queens
• Collaborators: New York State Department of Health
• Investigators: Principal Investigator: Mitchell I Chorost, MD, New York Hospital Queens

Publications and helpful links

General Publications

• Dasgupta M, Dumbrell AC. Preoperative risk assessment for delirium after noncardiac surgery: a systematic review. J Am Geriatr Soc. 2006 Oct;54(10):1578-89. doi: 10.1111/j.1532-5415.2006.00893.x.
• Dyer CB, Ashton CM, Teasdale TA. Postoperative delirium. A review of 80 primary data-collection studies. Arch Intern Med. 1995 Mar 13;155(5):461-5. doi: 10.1001/archinte.155.5.461.
• Folstein MF, Folstein SE, McHugh PR. "Mini-mental state". A practical method for grading the cognitive state of patients for the clinician. J Psychiatr Res. 1975 Nov;12(3):189-98. doi: 10.1016/0022-3956(75)90026-6. No abstract available.
• 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.
• Dubois MJ, Bergeron N, Dumont M, Dial S, Skrobik Y. Delirium in an intensive care unit: a study of risk factors. Intensive Care Med. 2001 Aug;27(8):1297-304. doi: 10.1007/s001340101017.
• Roach GW, Kanchuger M, Mangano CM, Newman M, Nussmeier N, Wolman R, Aggarwal A, Marschall K, Graham SH, Ley C. Adverse cerebral outcomes after coronary bypass surgery. Multicenter Study of Perioperative Ischemia Research Group and the Ischemia Research and Education Foundation Investigators. N Engl J Med. 1996 Dec 19;335(25):1857-63. doi: 10.1056/NEJM199612193352501.
• Jemal A, Siegel R, Xu J, Ward E. Cancer statistics, 2010. CA Cancer J Clin. 2010 Sep-Oct;60(5):277-300. doi: 10.3322/caac.20073. Epub 2010 Jul 7. Erratum In: CA Cancer J Clin. 2011 Mar-Apr;61(2):133-4.
• Norkiene I, Ringaitiene D, Misiuriene I, Samalavicius R, Bubulis R, Baublys A, Uzdavinys G. Incidence and precipitating factors of delirium after coronary artery bypass grafting. Scand Cardiovasc J. 2007 Jun;41(3):180-5. doi: 10.1080/14017430701302490.
• Marcantonio ER, Goldman L, Mangione CM, Ludwig LE, Muraca B, Haslauer CM, Donaldson MC, Whittemore AD, Sugarbaker DJ, Poss R, et al. A clinical prediction rule for delirium after elective noncardiac surgery. JAMA. 1994 Jan 12;271(2):134-9.
• Juliebo V, Bjoro K, Krogseth M, Skovlund E, Ranhoff AH, Wyller TB. Risk factors for preoperative and postoperative delirium in elderly patients with hip fracture. J Am Geriatr Soc. 2009 Aug;57(8):1354-61. doi: 10.1111/j.1532-5415.2009.02377.x. Epub 2009 Jul 2.
• Rolfson DB, McElhaney JE, Rockwood K, Finnegan BA, Entwistle LM, Wong JF, Suarez-Almazor ME. Incidence and risk factors for delirium and other adverse outcomes in older adults after coronary artery bypass graft surgery. Can J Cardiol. 1999 Jul;15(7):771-6.
• Layne OL Jr, Yudofsky SC. Postoperative psychosis in cardiotomy patients. The role of organic and psychiatric factors. N Engl J Med. 1971 Mar 11;284(10):518-20. doi: 10.1056/NEJM197103112841003. No abstract available.
• Dimsdale JE, Newton RP, Joist T. Neuropsychological side effects of beta-blockers. Arch Intern Med. 1989 Mar;149(3):514-25.
• Schubert DS, Gabinet L, Hershey LA. Psychosis induced by sustained-release procainamide. Can Med Assoc J. 1984 Nov 15;131(10):1188, 1190. No abstract available.
• Trohman RG, Castellanos D, Castellanos A, Kessler KM. Amiodarone-induced delirium. Ann Intern Med. 1988 Jan;108(1):68-9. doi: 10.7326/0003-4819-108-1-68. No abstract available.
• Binder EF, Cayabyab L, Ritchie DJ, Birge SJ. Diltiazem-induced psychosis and a possible diltiazem-lithium interaction. Arch Intern Med. 1991 Feb;151(2):373-4.
• Bohner H, Hummel TC, Habel U, Miller C, Reinbott S, Yang Q, Gabriel A, Friedrichs R, Muller EE, Ohmann C, Sandmann W, Schneider F. Predicting delirium after vascular surgery: a model based on pre- and intraoperative data. Ann Surg. 2003 Jul;238(1):149-56. doi: 10.1097/01.sla.0000077920.38307.5f.
• Redelmeier DA, Thiruchelvam D, Daneman N. Delirium after elective surgery among elderly patients taking statins. CMAJ. 2008 Sep 23;179(7):645-52. doi: 10.1503/cmaj.080443.
• Vgontzas AN, Kales A, Bixler EO, Manfredi RL, Tyson KL. Effects of lovastatin and pravastatin on sleep efficiency and sleep stages. Clin Pharmacol Ther. 1991 Dec;50(6):730-7. doi: 10.1038/clpt.1991.213.
• Lewis WH. Iatrogenic psychotic depressive reaction in hypertensive patients. Am J Psychiatry. 1971 Apr;127(10):1416-7. doi: 10.1176/ajp.127.10.1416. No abstract available.
• Brown JH, Sigmundson HK. Delirium from misuse of dimenhydrinate. Can Med Assoc J. 1969 Dec 13;101(12):49-50. No abstract available.
• Morgan DH. Neuro-psychiatric problems of cardiac surgery. J Psychosom Res. 1971 Mar;15(1):41-6. doi: 10.1016/0022-3999(71)90072-9. No abstract available.
• Briggs W, Ruppert D. Assessing the skill of yes/no predictions. Biometrics. 2005 Sep;61(3):799-807. doi: 10.1111/j.1541-0420.2005.00347.x.
• Briggs WM, Zaretzki R. The Skill Plot: a graphical technique for evaluating continuous diagnostic tests. Biometrics. 2008 Mar;64(1):250-6; discussion 256-61. doi: 10.1111/j.1541-0420.2007.00781_1.x.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): January 1, 2015
• Study Completion (Anticipated): January 1, 2015

Study Registration Dates

• First Submitted: April 23, 2012
• First Submitted That Met QC Criteria: June 15, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): June 19, 2012
• Last Update Submitted That Met QC Criteria: June 15, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: Inflammation; Surgery; Confusion; Aged; Delirium; Laparoscopy; Aged 80 and over; Acute Phase Reaction
• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium; Inflammation; Confusion; Acute-Phase Reaction
• Other Study ID Numbers: ECRIP