Status:
NOT_YET_RECRUITING
Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain
Lead Sponsor:
University of Rochester
Collaborating Sponsors:
Boston Children's Hospital
Connecticut Children's Medical Center
Conditions:
Thyroglossal Duct Cysts
Eligibility:
All Genders
3-17 years
Phase:
NA
Brief 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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
December 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
178 Patients enrolled
Trial Details
Trial ID
NCT07148895
Start Date
December 15 2025
End Date
December 31 2029
Last Update
December 10 2025
Active Locations (5)
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1
Children's Hospital Los Angeles
Los Angeles, California, United States, 90027
2
Connecticut Children's
Hartford, Connecticut, United States, 06107
3
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States, 60611
4
Boston Children's Hospital
Boston, Massachusetts, United States, 02115