Clinical Trial

Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain

Enrolling by Invitation
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Summary
Purpose of the Study: This study looks at how kids recover after a type of neck surgery called the Sistrunk procedure. Some kids have a small tube (called a drain) placed during surgery, and some do not. The goal is to see if using a drain makes a difference in how well they heal. Who Is in the Study: Children who are having surgery to remove a thyroglossal duct cyst-a common lump in the neck that some kids are born with. Main Questions the Study Wants to Answer: Does using a drain lower the chance of problems at the surgery site? Does using a drain change how often kids need more treatment or have to go back to the hospital? What Will Happen: Kids will have the Sistrunk surgery, with or without a drain. Doctors will watch how they heal and check for any problems, like infections, needing more procedures, or going back to the hospital.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2025-08-22; most recent amendment 2026-01-14.
Status change: Not Yet Recruiting → Enrolling by Invitation 2026-01-14
Trial Details
NCT Number NCT07148895
Lead Sponsor University of Rochester
Collaborators: Boston Children's Hospital, Connecticut Children's Medical Center, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital Los Angeles
Conditions Thyroglossal Duct Cysts
Enrollment 178 participants
Start Date 2026-01-09
Primary Completion 2028-12-31 (estimated)
Study Completion 2029-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-01-16