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Enrolling by Invitation

NCT Number: NCT07148895

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

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.

Enrolling by Invitation

Interested in participating?

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Key information

Conditions

Thyroglossal Duct Cysts Cysts Neoplasms Thyroglossal Cyst

Age range

3 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital Los Angeles, Los Angeles, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Post-surgical drain

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 post-surgical drain

Procedure

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

Primary outcomes

  1. Occurrence of Hematoma

    Time frame: 30 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.

  2. Occurrence of Seroma

    Time frame: 30 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.

  3. Occurrence of Surgical Site Infection (SSI)

    Time frame: 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.

Secondary outcomes

  1. Need for Return to Operating Room (OR) or Procedural Intervention

    Time frame: 30 days post-procedure

    The need for any surgical or procedural intervention related to the Sistrunk procedure will be recorded. A single value per participant is derived as the presence (yes) or absence (no) of an intervention. A "yes" indicates the participant required a return to the OR or procedure; a "no" indicates no intervention was required.

  2. Hospital Readmission

    Time frame: 30 days post-procedure

    Any unplanned hospital readmission lasting greater than 23 hours after initial discharge will be recorded. A single value per participant is derived as yes (readmitted) or no (not readmitted). A "yes" indicates a readmission occurred; a "no" indicates no readmission occurred.

  3. Hospital Length of Stay

    Time frame: 30 days post-procedure

    Hospital length of stay will be measured in total number of days admitted for the index hospitalization. A single value per participant is derived by counting the number of calendar days from admission to discharge. Higher numbers indicate longer hospitalization; lower numbers indicate shorter hospitalization.

  4. Need for Antibiotics

    Time frame: 30 days post-procedure

    Any prescription of antibiotics specifically related to wound healing will be recorded. A single value per participant is derived as yes (antibiotics prescribed) or no (not prescribed). A "yes" indicates antibiotics were required; a "no" indicates antibiotics were not required.

Sponsors and collaborators

Lead sponsor

University of Rochester

Other

Collaborators

  • Ann & Robert H Lurie Children's Hospital of Chicago
  • Boston Children's Hospital
  • Children's Hospital Los Angeles
  • Connecticut Children's Medical Center

Registry information

Official study title

A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement

Important dates

Study start
2026
Primary completion
2028
Study completion
2029
First posted
Aug 29, 2025
Registry last updated
Jan 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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