Clinical trial · Observational
Yield and Safety of Colonoscopy in Patients Older Than 80 Years
The Yield and Safety of Screening and Surveillance Colonoscopy in Elderly Patients (> 80 Years)
NCT00590434CI-TRIAL-00008345completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Neoplasms | Colorectal Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- 1
- description
- Patients older than 80 years presenting for average risk screening or surveillance colonoscopy
- label
- 2
- description
- Patients younger than 80 years presenting for average risk screening or surveillance colonoscopy
Primary outcomes (2)
- measure
- Proportion of elderly patients (>80 yrs) with colorectal neoplasia
- timeFrame
- 2 years
- measure
- proportion of patients with complications including perforation, bleeding, MI or CVA within 24 hours of colonoscopy in >80 vs. <80 agr group
- timeFrame
- 2 years
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (24)
- BACKGROUNDWinawer 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. PMID 12557158
- BACKGROUNDWinawer 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. doi: 10.1053/j.gastro.2006.03.012. PMID 16697750
- BACKGROUNDLin 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. doi: 10.1001/jama.295.20.2357. PMID 16720821
- BACKGROUNDStevens T, Burke CA. Colonoscopy screening in the elderly: when to stop? Am J Gastroenterol. 2003 Aug;98(8):1881-5. doi: 10.1111/j.1572-0241.2003.07576.x. PMID 12907348
- BACKGROUNDDuncan 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. doi: 10.1007/s10350-005-0306-3. PMID 16482421
- BACKGROUNDCooper 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. doi: 10.1016/j.amjmed.2005.06.019. PMID 16378787
- Cooper GS, Yuan Z, Landefeld CS, Johanson JF, Rimm AA. A national population-based study of incidence of colorectal cancer and age. Implications for screening in older Americans. Cancer. 1995 Feb 1;75(3):775-81. doi: 10.1002/1097-0142(19950201)75:33.0.co;2-d.