Six Versus Twelve Month Index Follow-up After Large Colon Polyp Resection

Part of paid clinical trials in Indianapolis, Indiana.

Sponsor
Indiana University
Study ID
NCT07198945
Status
Not Yet Recruiting

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Conditions

  • Adenoma
  • Colon Cancer
  • Colon Polyp
  • Endoscopic Resection
  • Recurrence, Local Neoplasm
  • Serrated Polyp

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 6-month follow-up — PROCEDURE
    Eligible patients randomized to the 6-month follow-up arm will undergo their first surveillance procedure 6 months after the removal of their large polyp to check for recurrent polyp tissue.
  • 12-month follow-up — PROCEDURE
    Eligible patients randomized to the 12-month follow-up arm will undergo their first surveillance procedure 12 months after the removal of their large polyp to check for recurrent polyp tissue.

Study Details

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 high grade dysplasia.

Key Dates

Start date
May 31, 2026
Status verified
Feb 2026
Primary completion
Nov 30, 2029
Completion
Jan 31, 2030

Study Design

Enrollment
546 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: 6-month follow-up
    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.
  • Experimental: 12-month follow-up
    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.

Primary Outcome Measure

Rate of recurrence [ Time Frame: 1 day ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Indiana UniversityIndianapolisIndiana46202
Rachel E Lahr, BA
[email protected]
317-278-2328
Jeremiah Shultz, BS
[email protected]
317-278-6222
John J Guardiola, MD (PRINCIPAL_INVESTIGATOR)
Douglas K Rex, MD (SUB_INVESTIGATOR)

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By specialty
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By research site
Indiana University· Indianapolis, IN

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