Clinical trial · Interventional
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
- Retrieved
- Sep 10, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260910-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Thyroglossal Duct Cysts | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| No post-surgical drain | Procedure | — | UNRESOLVED |
| Post-surgical drain | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Drain
- 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.
- interventionNames
- Procedure: Post-surgical drain
- type
- ACTIVE_COMPARATOR
- label
- No Drain
- description
- At the completion of the Sistrunk procedure, participants will not have a suction drain placed.
- interventionNames
- Procedure: No post-surgical drain
Primary outcomes (3)
- measure
- Occurrence of Hematoma
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 3 Years
- Maximum age
- 17 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDBrooks 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
- BACKGROUNDQureshi 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
- BACKGROUNDHong 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
- BACKGROUNDBrooks 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
- BACKGROUNDAthow 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