NCT07148895Enrolling by invitation
Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain
A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement
Source: ClinicalTrials.gov · Last updated 9 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Interventional
- Enrollment
- 178 (estimated)
- First submitted
- 22 Aug 2025
- Start date
- 9 Jan 2026
- Primary completion date
- 31 Dec 2028
- Lead sponsor
- University of Rochester
- NCT number
- NCT07148895
What you commit to
- Study type: Interventional
- Planned participants: 178
- From 9 Jan 2026 to the primary completion date, 31 Dec 2028
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with confirmed bleeding or immunodeficiency disorders as previously documented in electronic medical record.
- Revision surgery if prior formal Sistrunk performed.
Other illness
- Evidence of overt infection at the time of surgery
Other
- Lesions greater than 3cm on preoperative ultrasound or axial imaging
- Lingually positioned lesions.
- Coexistent lesion excision (e.g., branchial cleft cyst excision, thyroidectomy)
- Entry into oropharynx noted during procedure.
- Patients in whom the surgeon deems a drain is necessary.
Who the study is looking for
- 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.
Age in the registry: 3 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Boston Children's Hospital Coordinator of this site? Confirm its status | Boston | United States | Unknown status |
| Ann & Robert H. Lurie Children's Hospital of Chicago Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Connecticut Children's Coordinator of this site? Confirm its status | Hartford | United States | Unknown status |
| Children's Hospital Los Angeles Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| University of Rochester Medical Center Coordinator of this site? Confirm its status | Rochester | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.