Yield and Safety of Colonoscopy in Patients Older Than 80 Years - Full Text View

Sponsored by:	Kansas City Veteran Affairs Medical Center
Information provided by:	Kansas City Veteran Affairs Medical Center
ClinicalTrials.gov Identifier:	NCT00590434

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

MedlinePlus related topics: Cancer Colonoscopy Colorectal Cancer

U.S. FDA Resources

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

Further study details as provided by Kansas City Veteran Affairs Medical Center:

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 ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	1500
Study Start Date:	August 2006
Estimated Study Completion Date:	December 2009
Estimated 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

Contacts

Contact: April Higbee, RN

8168614700 ext 57456

april.higbee@va.gov

Locations

United States, Missouri
Kansascity VA Medical center	Recruiting
Kansas city, Missouri, United States, 64128
Contact: April Higbee, RN 816-861-4700 ext 57456 april.higbee@va.gov
Sub-Investigator: Prateek Sharma, MD
Sub-Investigator: Amit Rastogi, MD
Sub-Investigator: Jason Sugar, MD
Principal Investigator: Ajay Bansal, MD
Sub-Investigator: John Bonino, MD

Sponsors and Collaborators

Kansas City Veteran Affairs Medical Center

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:

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.

Winawer SJ, Zauber AG, Fletcher RH, Stillman JS, O'Brien MJ, Levin B, Smith RA, Lieberman DA, Burt RW, Levin TR, Bond JH, Brooks D, Byers T, Hyman N, Kirk L, Thorson A, Simmang C, Johnson D, Rex DK; US Multi-Society Task Force on Colorectal Cancer; American Cancer Society. Guidelines for colonoscopy surveillance after polypectomy: a consensus update by the US Multi-Society Task Force on Colorectal Cancer and the American Cancer Society. Gastroenterology. 2006 May;130(6):1872-85. Review.

Lin OS, Kozarek RA, Schembre DB, Ayub K, Gluck M, Drennan F, Soon MS, Rabeneck L. Screening colonoscopy in very elderly patients: prevalence of neoplasia and estimated impact on life expectancy. JAMA. 2006 May 24;295(20):2357-65.

Stevens T, Burke CA. Colonoscopy screening in the elderly: when to stop? Am J Gastroenterol. 2003 Aug;98(8):1881-5.

Duncan JE, Sweeney WB, Trudel JL, Madoff RD, Mellgren AF. Colonoscopy in the elderly: low risk, low yield in asymptomatic patients. Dis Colon Rectum. 2006 May;49(5):646-51.

Cooper GS, Chak A, Koroukian S. The polyp detection rate of colonoscopy: a national study of Medicare beneficiaries. Am J Med. 2005 Dec;118(12):1413.

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Gatto NM, Frucht H, Sundararajan V, Jacobson JS, Grann VR, Neugut AI. Risk of perforation after colonoscopy and sigmoidoscopy: a population-based study. J Natl Cancer Inst. 2003 Feb 5;95(3):230-6.

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.

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.

Ko CY, Chang JT, Chaudhry S, Kominski G. Are high-volume surgeons and hospitals the most important predictors of in-hospital outcome for colon cancer resection? Surgery. 2002 Aug;132(2):268-73.

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.

Cohen HA, Williams DO, Holmes DR Jr, Selzer F, Kip KE, Johnston JM, Holubkov R, Kelsey SF, Detre KM; NHLBI Dynamic Registry. Impact of age on procedural and 1-year outcome in percutaneous transluminal coronary angioplasty: a report from the NHLBI Dynamic Registry. Am Heart J. 2003 Sep;146(3):513-9.

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.

Chen H, Cantor A, Meyer J, Beth Corcoran M, Grendys E, Cavanaugh D, Antonek S, Camarata A, Haley W, Balducci L, Extermann M. Can older cancer patients tolerate chemotherapy? A prospective pilot study. Cancer. 2003 Feb 15;97(4):1107-14.

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Juarranz M, Calle-Purón ME, González-Navarro A, Regidor-Poyatos E, Soriano T, Martínez-Hernandez D, Rojas VD, Guinee VF. Physical exercise, use of Plantago ovata and aspirin, and reduced risk of colon cancer. Eur J Cancer Prev. 2002 Oct;11(5):465-72.

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Responsible Party:	Kansas city VA Medical Center ( Ajay Bansal )
Study ID Numbers:	AB0002
Study First Received:	December 26, 2007
Last Updated:	February 3, 2009
ClinicalTrials.gov Identifier:	NCT00590434 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by Kansas City Veteran Affairs Medical Center:

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

Study placed in the following topic categories:

Anti-Inflammatory Agents
Peripheral Vascular Diseases
Digestive System Neoplasms
Cerebral Infarction
Gastrointestinal Diseases
Colonic Diseases
Stroke
Vascular Diseases
Diabetes Mellitus
Intestinal Diseases
Rectal Diseases
Intestinal Neoplasms

Coronary Disease
Digestive System Diseases
Analgesics, Non-Narcotic
Gastrointestinal Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Infarction
Myocardial Infarction
Colorectal Neoplasms
Coronary Artery Disease

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Digestive System Neoplasms
Gastrointestinal Diseases
Physiological Effects of Drugs
Colonic Diseases
Intestinal Diseases
Rectal Diseases
Pharmacologic Actions
Intestinal Neoplasms
Neoplasms
Neoplasms by Site

Digestive System Diseases
Sensory System Agents
Analgesics, Non-Narcotic
Therapeutic Uses
Gastrointestinal Neoplasms
Anti-Inflammatory Agents, Non-Steroidal
Peripheral Nervous System Agents
Analgesics
Antirheumatic Agents
Colorectal Neoplasms

ClinicalTrials.gov processed this record on May 07, 2009