We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Yield and Safety of Colonoscopy in Patients Older Than 80 Years

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00590434
Recruitment Status : Completed
First Posted : January 10, 2008
Last Update Posted : October 26, 2012
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease
Colorectal Neoplasms

  Show Detailed Description

Study Design

Study Type : Observational
Actual Enrollment : 169 participants
Observational Model: Case Control
Time Perspective: Retrospective
Official Title: The Yield and Safety of Screening and Surveillance Colonoscopy in Elderly Patients (> 80 Years)
Study Start Date : August 2006
Primary Completion Date : December 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
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


Outcome Measures

Primary Outcome Measures :
  1. Proportion of elderly patients (>80 yrs) with colorectal neoplasia [ Time Frame: 2 years ]
  2. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00590434


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

Additional Information:
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
First Posted: January 10, 2008    Key Record Dates
Last Update Posted: October 26, 2012
Last Verified: October 2012

Keywords provided by Ajay Bansal, 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:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases