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

University of Rochester

Status: Invitation-only

Conditions: Thyroglossal Duct Cysts

Treatments: Procedure: No post-surgical drain; Procedure: Post-surgical drain

Study type: Interventional

Funder types: Other

Identifiers

NCT07148895

STUDY00010365

Details and patient eligibility

About

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.

Enrollment: 178 estimated patients

Sex: All

Ages: 3 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

178 participants in 2 patient groups

Drain

Active Comparator group

Description:

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.

Treatment:

Procedure: Post-surgical drain

No Drain

Active Comparator group

Description:

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

Treatment:

Procedure: No post-surgical drain