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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

178 participants

Study Classification

INTERVENTIONAL

Study Start Date

2026-01-09

Study Completion Date

2029-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Thyroglossal Duct Cysts

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drain

During surgery, at the completion of the Sistrunk procedure, participants will have a suction drain placed. The drain will be removed later based on standard criteria prior to discharge from the hospital.

Group Type ACTIVE_COMPARATOR

Post-surgical drain

Intervention Type PROCEDURE

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.

No Drain

At the completion of the Sistrunk procedure, participants will not have a suction drain placed.

Group Type ACTIVE_COMPARATOR

No post-surgical drain

Intervention Type PROCEDURE

Patients will be recovered in SOC manner from Sistrunk surgery without drain placement

Interventions

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Post-surgical drain

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.

Intervention Type PROCEDURE

No post-surgical drain

Patients will be recovered in SOC manner from Sistrunk surgery without drain placement

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

3 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No