Follow-Up Intervals for Colon Polyps

(STARLING Trial)

Overseen By Rachel E Lahr, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Indiana University

Disqualifiers: Inflammatory bowel disease, Polyposis syndromes, Colorectal cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether a follow-up colonoscopy 6 months or 12 months after removing a large colon polyp is more effective at detecting regrowth. It focuses on polyps measuring 20-50mm that do not exhibit severe abnormal cell growth (high-grade dysplasia). Individuals who have had a large non-pedunculated polyp removed during a colonoscopy and can complete a simple electronic survey are suitable candidates for this study. As an unphased trial, it offers participants the chance to contribute to important research that could enhance follow-up care for others.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that these follow-up intervals are safe?

Research has shown that a check-up 12 months after removing a large polyp is generally safe for most people. However, a small chance exists that waiting a year could delay the detection of new problems, though this is uncommon.

A 6-month check-up is also a common practice for monitoring large polyps. This shorter interval can help identify new growths sooner, providing reassurance.

Both the 6-month and 12-month follow-up times are standard and safe for patients. The choice between them may depend on individual health needs and a doctor's recommendation. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it aims to find out the best follow-up interval after removing large colon polyps. Unlike the standard practice of recommending follow-ups based on general guidelines, this trial specifically compares 6-month and 12-month intervals. By determining if one interval is more effective at detecting regrowth earlier, the trial could lead to more personalized and timely care, potentially catching issues sooner and improving patient outcomes. This could refine current practices and provide clearer guidelines for patients and doctors.

What evidence suggests that this trial's follow-up intervals could be effective for colon polyps?

This trial will compare two follow-up intervals for patients after large polyp removal: a 12-month follow-up and a 6-month follow-up. Studies have shown that the timing of check-ups after polyp removal can influence how soon new polyps are detected. A 12-month follow-up often monitors patients after large polyps are removed, especially when there's no immediate cancer concern. However, some experts believe that waiting 12 months might delay early detection of new issues. Alternatively, a 6-month follow-up is sometimes recommended for larger polyps, as it can help detect regrowth sooner. This shorter interval aligns with some guidelines suggesting early checks for large polyps. Both options have their pros and cons, and the decision typically depends on personal risk factors and medical advice. ^{1 3 5 6 7}

Who Is on the Research Team?

John J Guardiola, MD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for individuals who have had a large non-pedunculated colon polyp (20-50mm) removed, which did not show high-grade dysplasia. Specific eligibility criteria are not provided, but typically participants should meet certain health standards and may be excluded based on factors that could impact the study's results.

Inclusion Criteria

Polyp must be size 20-50 mm as documented with photo containing open snare of known size as comparison

I am 18 years old or older.

I can understand and agree to the study's details.

Exclusion Criteria

Patients who have more than three ≥ 20mm polyps removed during the index colonoscopy

Patients with significant acute or chronic medical, neurologic, or illness that, in the judgment of the Principal Investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study

Pedunculated or semi-pedunculated polyps (as defined by Paris Classification type Ip or Isp)

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Removal of large non-pedunculated colorectal polyps 20-50 mm in size without high grade dysplasia

1 day

Follow-up

Participants undergo surveillance colonoscopy to assess for polyp recurrence

6 to 12 months

1 visit (in-person)

Post-Follow-up Monitoring

Monitoring for adverse events and assessment of patient experience post-follow-up procedure

30 days

What Are the Treatments Tested in This Trial?

Interventions

• 12-month follow-up
• 6-month follow-up

Trial Overview The study aims to determine whether a follow-up at 6 months is as effective as a follow-up at 12 months after the removal of large colon polyps. It compares two groups: one receiving an earlier checkup and another with a later checkup to monitor for any signs of polyp recurrence or complications.

How Is the Trial Designed?

Group I: 6-month follow-up Experimental Treatment 1 Intervention

Patients will be recommended to complete their first surveillance procedure 6 months after the large polyp removal procedure in order to assess whether the polyp grew back.

Group II: 12-month follow-up Experimental Treatment 1 Intervention

Patients will be recommended to complete their first surveillance procedure 12 months after the large polyp removal procedure in order to assess whether the polyp grew back.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11317626/

Post-polypectomy surveillance: follow-up recommendations ... USMSTF recommends colonoscopy in 3–5 years for 3–4 sessile serrated polyps (<10 mm) and colonoscopy in 3 years for 5–10 sessile serrated polyps ...

2. giejournal.org giejournal.org/article/S0016-5107(24)03194-8/fulltext

Safety of first surveillance colonoscopy at 12 months after ... Potential downsides of an initial 12-month surveillance interval include the theoretical risk of a delay in the diagnosis of cancer at initial ...

3. gastro.org gastro.org/clinical-guidance/follow-up-after-colonoscopy-and-polypectomy-a-consensus-update-by-the-u-s-multi-society-task-force-on-colorectal-cancer/

Follow-up after colonoscopy and polypectomy A 3-year follow-up interval is favored if concern about pathologist consistency in distinguishing SSPs from HPs, quality of bowel preparation, or complete ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT07198945?term=NA

Six Versus Twelve Month Index Follow-up After Large ... The study will compare the use of a 6-month follow-up vs a 12-month follow-up after the removal of a large non-pedunculated polyp 20-50mm in size and without ...

5. asge.org asge.org/docs/default-source/guidelines/recommendations-for-follow-up-after-colonoscopy-and-polypectomy-a-consensus-update-by-the-us-multi-society-task-force-on-colorectal-cancer-2020-march-gie.pdf

Recommendations for Follow-Up After Colonoscopy and ... Among patients with polyps, new data suggest that patients with 1–2 adenomas <10 mm are at lower than average risk for incident and fatal CRC and can undergo ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10120516/

Utility of repeat colonoscopy within 1 year: a patient-level ... The majority of repeat colonoscopies in this study involved patients with new gastrointestinal symptoms, patients with polyps, and patients with poor bowel ...

7. journals.lww.com journals.lww.com/ajg/fulltext/2025/10002/s617_reaching_the_unscreened__adherence_outcomes.617.aspx

S616 Long-Term Outcomes Following Resection of Large ... Current guidelines recommend a follow-up colonoscopy 6 months after endoscopic resection of large non-pedunculated colorectal polyps (LNPCPs).