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ConfusionNCT01623297

Confusion in the Elderly After Colon Surgery

An observational study of Confusion and Inflammation, run by New York Hospital Queens at 1 site in United States.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Confusion, Inflammation, Acute Phase Reaction
How many people
52 participants
Where
1 siteUnited States
Study dates
Jan 2012to Jan 2015
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

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

Who may be able to join

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

Who cannot join

  • 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"
Show all 21Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

Mitchell Chorost, MD contact

718-670-1185

mchorost@nyp.org

Mitchell I Chorost, MD contact

718-670-1185

mchorost@nyp.org

United States1 site, 1 recruiting

  • New York Hospital Queens

    Flushing, New York, 11355

    Mitchell I Chorost, MD, 718-670-1185, mchorost@nyp.org

    Mitchell I Chorost, MD

    Recruiting

Other trials in United States

About this study

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?

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

Read the 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.

Keywords
Laparoscopy, Surgery, Acute Phase Reaction, Aged, Aged 80 and over, Confusion, Inflammation, Delirium
Medical subject headings
Confusion, Inflammation, Acute-Phase Reaction, Delirium

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01623297
Study groupRoleWhat they receive
Laparoscopic colon surgeryPatients over age 65 having laparoscopic colon resection for colonic adenocarcinoma
Open colon surgeryPatients over age 65 having open colon resection for colonic adenocarcinoma

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Confusion

    Confusion assessed by questionaires and cognitive testing

    Measured: 6 Months

Secondary outcomes (5)

  1. degree of inflammation

    5 separate blood draws

    Measured: 6 Months

  2. presence of electrolyte imbalance

    5 separate blood draws

    Measured: 6 months

  3. pituitary-thyroid axis disruption

    5 separate blood draws

    Measured: 6 months

  4. liver function tests

    5 separate blood draws

    Measured: 6 months

  5. nutritional status

    5 separate blood draws

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jun 2012 (estimated)
  2. Study startJan 2012
  3. Primary completionJan 2015 (estimated)
  4. Study completionJan 2015 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Prospective
Enrolment
52 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01623297
Sponsor's protocol ID
ECRIP
Status last verified
Jun 2012
First submitted
23 Apr 2012
Last updated
19 Jun 2012
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 20610543

  • 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.

    PubMed 7864702

  • 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.

    PubMed 19573218

  • 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.

    PubMed 20069607

  • 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.

    PubMed 10411615

  • 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.

    PubMed 8948560

  • 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.

    PubMed 5100723

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

    PubMed 2563932

  • 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.

    PubMed 6498664

  • 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.

    PubMed 3337520

  • 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.

    PubMed 1899553

  • 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.

    PubMed 12832977

  • 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.

    PubMed 17038078

  • 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.

    PubMed 8264068

  • 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.

    PubMed 18809895

Questions about this trial

What is this clinical trial studying?

An observational study of Confusion and Inflammation, run by New York Hospital Queens at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 19 Jun 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Mitchell Chorost, MD (718-670-1185, mchorost@nyp.org), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Confusion (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01623297, which also lists 24 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Jun 2012.

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