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NCT07148895

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

Enrolling by Invitation
NAAges 3–17InterventionalTreatment
University of Rochester
~178 participants
Updated 2026-01-16 on ClinicalTrials.gov
What's tested:Post-surgical drainNo post-surgical drain

At a glance

Recruiting sites
0 of 5 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of Hematoma
Measured over 30 days post-procedure
+2 more outcomes measured

Conditions

Thyroglossal Duct Cysts

Explore related trials

Thyroglossal Duct Cyst

Where it's being run

5 sites across 5 states
California1
Connecticut1
Illinois1
Massachusetts1
New York1

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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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.

What this trial measures

  • Occurrence of Hematoma30 days post-procedure

    The occurrence of hematoma will be assessed. A hematoma is defined as a localized collection of blood at the surgical site that is clinically significant and requires management beyond observation (e.g., drainage, surgical evacuation). A single value per participant is derived as yes (hematoma present) or no (hematoma absent). A "yes" indicates a hematoma occurred; a "no" indicates no hematoma occurred.

  • Occurrence of Seroma30 days post-procedure

    The occurrence of seroma will be assessed. A seroma is defined as a localized collection of serous fluid at the surgical site that is clinically significant and requires intervention (e.g., aspiration or drainage). A single value per participant is derived as yes (seroma present) or no (seroma absent). A "yes" indicates a seroma occurred; a "no" indicates no seroma occurred.

  • Occurrence of Surgical Site Infection (SSI)30 days post-procedure

    The occurrence of surgical site infection will be assessed. An SSI is defined as an infection at the surgical site requiring treatment (e.g., antibiotics, wound drainage). A single value per participant is derived as yes (infection present) or no (infection absent). A "yes" indicates an infection occurred; a "no" indicates no infection occurred.