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

NCT07148895 | Enrolling By Invitation

• 1 other identifier: STUDY00010365
• Study Type: interventional
• Target: 178
• Locations: 1 country
• Sites: 5

Brief Summary

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.

Conditions

Thyroglossal Duct Cysts

Keywords

Sistrunk procedure

Outcome Measures

Primary Outcomes (3)

• 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.

  30 days post-procedure

• Occurrence of Seroma

  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.

  30 days post-procedure

• Occurrence of Surgical Site Infection (SSI)

  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.

  30 days post-procedure

Secondary Outcomes (4)

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

  30 days post-procedure

• Hospital Readmission

  30 days post-procedure

• Hospital Length of Stay

  30 days post-procedure

• Need for Antibiotics

  30 days post-procedure

Study Arms (2)

Drain

ACTIVE COMPARATOR

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.

Procedure: Post-surgical drain

No Drain

ACTIVE COMPARATOR

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

Procedure: No post-surgical drain

Interventions

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.

Drain

No post-surgical drain PROCEDURE

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

No Drain

Eligibility Criteria

• Age: 3 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead
• Boston Children's Hospital: collaborator
• Connecticut Children's Medical Center: collaborator
• Ann & Robert H Lurie Children's Hospital of Chicago: collaborator
• Children's Hospital Los Angeles: collaborator

Study Sites (5)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Connecticut Children's

Hartford, Connecticut, 06107, United States

Location

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (5)

• Brooks JA, Cunningham MJ, Hughes AL, Kawai K, Dombrowski ND, Adil E. Postoperative Disposition Following Pediatric Sistrunk Procedures: A National Database Query. Laryngoscope. 2021 Jul;131(7):E2352-E2355. doi: 10.1002/lary.29331. Epub 2021 Jan 11.

  PMID: 33427321 BACKGROUND

• Qureshi TA, Suhail A, Zaidi SS, Siddiq W. Is There Any Benefit of Drain Placement on Postoperative Complications in Patients Undergoing the Sistrunk Procedure? Int Arch Otorhinolaryngol. 2015 Oct;19(4):331-5. doi: 10.1055/s-0035-1549156. Epub 2015 Mar 27.

  PMID: 26491480 BACKGROUND

• Hong P. Is drain placement necessary in pediatric patients who undergo the Sistrunk procedure? Am J Otolaryngol. 2014 Sep-Oct;35(5):628-30. doi: 10.1016/j.amjoto.2014.04.005. Epub 2014 May 4.

  PMID: 24888796 BACKGROUND

• Brooks JA, Cunningham MJ, Koempel JA, Kawai K, Huang JK, Weitzman RE, Osterbauer B, Hughes AL. To drain or not to drain following a Sistrunk procedure: A dual institutional experience. Int J Pediatr Otorhinolaryngol. 2019 Dec;127:109645. doi: 10.1016/j.ijporl.2019.109645. Epub 2019 Aug 19.

  PMID: 31494373 BACKGROUND

• Athow AC, Fagg NL, Drake DP. Management of thyroglossal cysts in children. Br J Surg. 1989 Aug;76(8):811-4. doi: 10.1002/bjs.1800760815.

  PMID: 2765833 BACKGROUND

MeSH Terms

Conditions

Thyroglossal Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor - Department of Otolaryngology (SMD)

Study Record Dates

• First Submitted: August 22, 2025
• First Posted: August 29, 2025
• Study Start: January 9, 2026
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2029
• Last Updated: January 16, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

US (5)