← Back to Search

Colonoscopy vs Stool Testing for Colorectal Polyps (COOP Trial)

N/A

Recruiting

Led By Audrey H Calderwood, MD, MS

Research Sponsored by Dartmouth-Hitchcock Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years

Awards & highlights

No Placebo-Only Group

Summary

This trial compares two ways to monitor colon health after polyps are removed: FIT testing & colonoscopy. People aged 70-82 with a history of polyps can take part.

Who is the study for?

Adults aged 70-82 with a history of one or two non-advanced colorectal polyps and due for surveillance colonoscopy can join. They must speak English or Spanish and be able to consent. Those with serious heart, lung, liver, kidney diseases, dementia affecting daily activities, recent stroke or cancer diagnosis are excluded.

What is being tested?

The trial is comparing yearly stool tests (FIT) versus the standard colonoscopy to monitor older adults who previously had colon polyps. It's a randomized controlled trial across multiple sites where participants are randomly assigned to either method.

What are the potential side effects?

Colonoscopy may cause discomfort, bleeding, or perforation of the colon wall in rare cases. Stool testing (FIT) is generally safe but may lead to follow-up procedures like a colonoscopy if results indicate abnormal findings.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 1 year after surveillance colonoscopy, annually after each completed fit for up to 6 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Advance Directives

Secondary study objectives

Change from baseline Emotional benefit of surveillance assessed by a modified version of the Psychological Consequences Questionnaire (PCQ)

Colorectal Carcinoma

Change from baseline Satisfaction and Trust of colorectal screening testing assessed by Tiro et al (2005) Response Efficacy sub-scale from the general colorectal cancer screening survey.

+3 more