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Yield and Safety of Colonoscopy in Patients Older Than 80 Years

This study has been completed.
Sponsor:
Collaborator:
Department of Veterans Affairs
Information provided by (Responsible Party):
Ajay Bansal, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier:
NCT00590434
First received: December 26, 2007
Last updated: October 25, 2012
Last verified: October 2012
History of Changes
  Purpose

The aim of the study is to study the risk of colorectal cancer and polyps in people older than 80 years compared to the younger age group. The researchers hypothesized that colonoscopy in older people is likely to have more complications without detection of a significant number of large polyps and cancer.


Condition
Colorectal Neoplasms

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Yield and Safety of Screening and Surveillance Colonoscopy in Elderly Patients (> 80 Years)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Midwest Biomedical Research Foundation:

Primary Outcome Measures:
  • Proportion of elderly patients (>80 yrs) with colorectal neoplasia [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • proportion of patients with complications including perforation, bleeding, MI or CVA within 24 hours of colonoscopy in >80 vs. <80 agr group [ Time Frame: 2 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Five year disease free survival and five year mortality rates after the diagnosis of colon cancer in older (>80 yrs) vs. younger group (<80 yrs) [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Enrollment: 169
Study Start Date: August 2006
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients older than 80 years presenting for average risk screening or surveillance colonoscopy
2
Patients younger than 80 years presenting for average risk screening or surveillance colonoscopy

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

The study population is a Veteran population presenting to a VA Hospital upper endoscopy unit

Criteria

Inclusion Criteria:

  • All patients presenting for colonoscopy after 1997
  • Age 80 or older for the study group
  • Age 50-79 for the control group
  • Indications for colonoscopy:
  • Average risk screening for CRC
  • Surveillance of polyps (tubular adenomas)

Exclusion Criteria:

  • Any colonoscopy done for symptoms (abdominal pain, weight loss, hematochezia, occult blood in stool, etc) or signs (iron deficiency anemia)
  • Patients who are not average risk based on family history of CRC
  • Diagnosis of ulcerative colitis or Crohn's Disease
  • History of CRC
  • Exams that were not completed to the cecum (except in cases of obstructing masses found to be neoplastic) or poor bowel preparation limiting visualization of the mucosa
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00590434

Locations
United States, Missouri
Kansascity VA Medical center
Kansas city, Missouri, United States, 64128
Sponsors and Collaborators
Midwest Biomedical Research Foundation
Department of Veterans Affairs
Investigators
Principal Investigator: Ajay Bansal, MD Kansas city VA Medical Center
  More Information

Additional Information:
NCI Colorectal statistics  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Ajay Bansal, Principal Investigator, Staff Physician, Midwest Biomedical Research Foundation
ClinicalTrials.gov Identifier: NCT00590434     History of Changes
Other Study ID Numbers: AB0002
Study First Received: December 26, 2007
Last Updated: October 25, 2012
Health Authority: United States: Federal Government

Keywords provided by Midwest Biomedical Research Foundation:
CRC - Colorectal cancer
CVA - Cerebral Vascular Accident
MI - Myocardial Infarction
CAD - Coronary Artery Disease
DM - Diabetes Mellitus
 PVD - Peripheral Vascular Disease
NSAIDS - Non-Steroidal Anti inflammatory Drugs
screening
colonoscopy

Additional relevant MeSH terms:
Neoplasms
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases
 Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents

ClinicalTrials.gov processed this record on June 13, 2013