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

N/AEnrolling By InvitationNCT07148895

University of Rochester178 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

178

Conditions

Thyroglossal Duct Cysts

Interventions

During surgery, at the completion of the Sistrunk procedure, participants in the drain cohort will have a suction drain placed, which will be removed based on standard criteria prior to discharge from the hospital. Wound care following drain removal will be standardized, with instructions for patients to allow the area to heal naturally and to follow a regimen of cleaning and applying topical antibiotic ointment for several days.

Eligibility

Sex: ALLMin age: 3 YearsMax age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * 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 Criteria: * 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.

Locations (5)

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

Outcomes

Primary Outcomes

Occurrence of Hematoma

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.