NCT01623297

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2012

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

June 19, 2012

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

June 19, 2012

Status Verified

June 1, 2012

Enrollment Period

3 years

First QC Date

April 23, 2012

Last Update Submit

June 15, 2012

Conditions

ConfusionInflammationAcute Phase ReactionSurgeryDelirium

Keywords

LaparoscopySurgeryAcute Phase ReactionAgedAged 80 and overConfusionInflammationDelirium

Outcome Measures

Primary Outcomes (1)

  • Confusion

    Confusion assessed by questionaires and cognitive testing

    6 Months

Secondary Outcomes (5)

  • degree of inflammation

    6 Months

  • presence of electrolyte imbalance

    6 months

  • pituitary-thyroid axis disruption

    6 months

  • liver function tests

    6 months

  • nutritional status

    6 months

Study Arms (2)

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

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients newly diagnosed with colon adenocarcinoma will be contacted after being scheduled for surgery at New York Hospital Queens.

You may qualify if:

  • Patients over age 65.0 years and in need of elective colon resection for adenocarcinoma

You may not qualify if:

  • 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
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York Hospital Queens

Flushing, New York, 11355, United States

RECRUITING

Related Publications (24)

  • 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.

    PMID: 20610543BACKGROUND

  • 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.

    PMID: 7864702BACKGROUND

  • 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.

    PMID: 19573218BACKGROUND

  • 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.

    PMID: 20069607BACKGROUND

  • 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.

    PMID: 10411615BACKGROUND

  • 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.

    PMID: 8948560BACKGROUND

  • 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.

    PMID: 5100723BACKGROUND

  • Dimsdale JE, Newton RP, Joist T. Neuropsychological side effects of beta-blockers. Arch Intern Med. 1989 Mar;149(3):514-25.

    PMID: 2563932BACKGROUND

  • 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.

    PMID: 6498664BACKGROUND

  • 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.

    PMID: 3337520BACKGROUND

  • 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.

    PMID: 1899553BACKGROUND

  • 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.

    PMID: 12832977BACKGROUND

  • 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.

    PMID: 17038078BACKGROUND

  • 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.

    PMID: 8264068BACKGROUND

  • 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.

    PMID: 18809895BACKGROUND

  • 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.

    PMID: 1752118BACKGROUND

  • 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.

    PMID: 5549939BACKGROUND

  • 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.

    PMID: 17487768BACKGROUND

  • 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.

    PMID: 11511942BACKGROUND

  • Brown JH, Sigmundson HK. Delirium from misuse of dimenhydrinate. Can Med Assoc J. 1969 Dec 13;101(12):49-50. No abstract available.

    PMID: 5362300BACKGROUND

  • 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.

    PMID: 5576344BACKGROUND

  • 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.

    PMID: 16135031BACKGROUND

  • 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.

    PMID: 18304288BACKGROUND

  • 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.

    PMID: 1202204BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma samples stored up to 7 months then expired and discarded

MeSH Terms

Conditions

ConfusionInflammationAcute-Phase ReactionDelirium

Condition Hierarchy (Ancestors)

Neurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic ProcessesNeurocognitive DisordersMental Disorders

Study Officials

  • Mitchell I Chorost, MD

    New York Hospital Queens

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mitchell Chorost, MD

CONTACT

718-670-1185mchorost@nyp.org

Mitchell I Chorost, MD

CONTACT

718-670-1185mchorost@nyp.org

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

April 23, 2012

First Posted

June 19, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

June 19, 2012

Record last verified: 2012-06

Locations

US(1)