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

Enrolling by invitation · Not applicable

Conditions studied: Thyroglossal Duct Cysts

In brief

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.

Key facts

Study ID

NCT07148895

Run by

University of Rochester

People needed

178

Starts

2026-01-09

Expected to finish

2029-12-31

Last updated by the study team

2026-01-16

Who can join

Age: 3 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Children aged 18 and younger
• Diagnosis of a <3cm midline neck mass, tract or sinus as determined by preoperative physical examination and imaging
• Patient scheduled for Sistrunk procedure (excision of TGDC)
• Patient assigned to the drain or no drain groups at the time of surgery.
• Sistrunk procedure performed per best practices and standardized per surgical study protocol.
• Patient admitted for overnight observation.
• Thyroglossal duct cyst confirmed on final pathology.

You may not qualify if…

• Patients with confirmed bleeding or immunodeficiency disorders as previously documented in electronic medical record.
• Lesions greater than 3cm on preoperative ultrasound or axial imaging
• Lingually positioned lesions.
• Evidence of overt infection at the time of surgery
• Coexistent lesion excision (e.g., branchial cleft cyst excision, thyroidectomy)
• Entry into oropharynx noted during procedure.
• Revision surgery if prior formal Sistrunk performed.
• Patients in whom the surgeon deems a drain is necessary.

Where it is running

• Children's Hospital Los Angeles — Los Angeles, California, United States
• Connecticut Children's — Hartford, Connecticut, United States
• Ann & Robert H. Lurie Children's Hospital of Chicago — Chicago, Illinois, United States
• Boston Children's Hospital — Boston, Massachusetts, United States
• University of Rochester Medical Center — Rochester, New York, United States

Full record on ClinicalTrials.gov

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