Yield and Safety of Colonoscopy in Patients Older Than 80 Years

NCT00590434 | Completed

• 1 other identifier: AB0002
• Study Type: observational
• Target: 169
• Locations: 1 country
• Sites: 1

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.

Conditions

Colorectal Neoplasms

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Proportion of elderly patients (>80 yrs) with colorectal neoplasia

  2 years

• proportion of patients with complications including perforation, bleeding, MI or CVA within 24 hours of colonoscopy in >80 vs. <80 agr group

  2 years

Secondary Outcomes (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)

  2 years

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Midwest Biomedical Research Foundation: lead
• US Department of Veterans Affairs: collaborator

Study Sites (1)

Kansascity VA Medical center

Kansas City, Missouri, 64128, United States

Location

Related Publications (24)

• Winawer S, Fletcher R, Rex D, Bond J, Burt R, Ferrucci J, Ganiats T, Levin T, Woolf S, Johnson D, Kirk L, Litin S, Simmang C; Gastrointestinal Consortium Panel. Colorectal cancer screening and surveillance: clinical guidelines and rationale-Update based on new evidence. Gastroenterology. 2003 Feb;124(2):544-60. doi: 10.1053/gast.2003.50044.

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  PMID: 12569145 BACKGROUND

• Cappell MS. Safety and efficacy of colonoscopy after myocardial infarction: an analysis of 100 study patients and 100 control patients at two tertiary cardiac referral hospitals. Gastrointest Endosc. 2004 Dec;60(6):901-9. doi: 10.1016/s0016-5107(04)02277-1.

  PMID: 15605004 BACKGROUND

• Villa VM, Harada ND, Washington D, Damron-Rodriguez J. The health and functional status of US veterans aged 65+: implications for VA health programs serving an elderly, diverse veteran population. Am J Med Qual. 2003 May-Jun;18(3):108-16. doi: 10.1177/106286060301800304.

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• Houry S, Amenabar J, Rezvani A, Huguier M. Should patients over 80 years old be operated on for colorectal or gastric cancer? Hepatogastroenterology. 1994 Dec;41(6):521-5.

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• Clipp EC, Carver EH, Pollak KI, Puleo E, Emmons KM, Onken J, Farraye FA, McBride CM. Age-related vulnerabilities of older adults with colon adenomas: evidence from Project Prevent. Cancer. 2004 Mar 1;100(5):1085-94. doi: 10.1002/cncr.20082.

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Related Links

• NCI Colorectal statistics

MeSH Terms

Conditions

Colorectal Neoplasms; Stroke; Myocardial Infarction; Coronary Artery Disease; Diabetes Mellitus; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Myocardial Ischemia; Heart Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Ajay Bansal, MD

  Kansas City VA Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Staff Physician

Study Record Dates

• First Submitted: December 26, 2007
• First Posted: January 10, 2008
• Study Start: August 1, 2006
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 26, 2012

Record last verified: 2012-10

Locations

US (1)