Thyroglossal Duct CystsNCT07148895
Assessing Post-operative Outcomes After Children's Sistrunk Procedure With or Without a Drain
A study testing Post-surgical drain and No post-surgical drain in people with Thyroglossal Duct Cysts, run by University of Rochester at 5 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 3 to 17 years
- Conditions the study is for
- Thyroglossal Duct Cysts
- What is being tested?
- Post-surgical drain and No post-surgical drain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 178 participants
- Where
- 5 sitesUnited States
- Study dates
- 9 Jan 2026to 31 Dec 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 3 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
United States5 sites
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Connecticut Children's
Hartford, Connecticut, 06107
Children's Hospital Los Angeles
Los Angeles, California, 90027
University of Rochester Medical Center
Rochester, New York, 14642
About this study
Official title: A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement
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.
Read more
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
- Being tested
- Post-surgical drain, No post-surgical drain
- Keywords
- Sistrunk procedure
- Medical subject headings
- Thyroglossal Cyst
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Post-surgical drainProcedure or surgery
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 drainProcedure or surgery
Patients will be recovered in SOC manner from Sistrunk surgery without drain placement
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Post-surgical drain |
| No Drain | Active comparator | At the completion of the Sistrunk procedure, participants will not have a suction drain placed. Receives: Procedure: No post-surgical drain |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 30 days post-procedure
Secondary outcomes (4)
Need for Return to Operating Room (OR) or Procedural Intervention
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.
Measured: 30 days post-procedure
Hospital Readmission
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.
Measured: 30 days post-procedure
Hospital Length of Stay
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.
Measured: 30 days post-procedure
Need for Antibiotics
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.
Measured: 30 days post-procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Aug 2025
- Study start9 Jan 2026
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Thyroglossal Duct CystsStudies of the same condition, open and under way.
- More trials run by University of RochesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Rochester
- Sponsor type
- University, hospital or other
- Collaborators
- Boston Children's Hospital, Connecticut Children's Medical Center, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital Los Angeles
- Responsible party
- Principal investigator, Jennifer Brooks, University of Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07148895
- Sponsor's protocol ID
- STUDY00010365
- Status last verified
- Jan 2026
- First submitted
- 22 Aug 2025
- Last updated
- 9 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 33427321Qureshi 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.
PubMed 26491480Hong 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.
PubMed 24888796Brooks 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.
PubMed 31494373Athow 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.
PubMed 2765833
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center Trial Assessing Post-Operative Outcomes Following Pediatric Sistrunk Procedures With or Without Drain Placement
- ClinicalTrials.gov ID
- NCT07148895
- Acronym / sponsor ID
- STUDY00010365
- Conditions
- Thyroglossal Duct Cysts
- Keywords
- Sistrunk procedure
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- University of RochesterUniversity, hospital or other
- Collaborators
- Boston Children's Hospital, Connecticut Children's Medical Center, Ann & Robert H Lurie Children's Hospital of Chicago, Children's Hospital Los Angeles
- Study start
- 9 Jan 2026 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 29 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Drain | Active comparator | Procedure: Post-surgical drainDuring 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. |
| No Drain | Active comparator | Procedure: No post-surgical drainAt the completion of the Sistrunk procedure, participants will not have a suction drain placed. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Post-surgical drainDuring 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. | Procedure or surgery | Drain |
| No post-surgical drainPatients will be recovered in SOC manner from Sistrunk surgery without drain placement | Procedure or surgery | No Drain |
Primary outcome
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.
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.
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.
4 secondary outcomes
Need for Return to Operating Room (OR) or Procedural Intervention
Time frame: 30 days post-procedure
Hospital Readmission
Time frame: 30 days post-procedure
Hospital Length of Stay
Time frame: 30 days post-procedure
Need for Antibiotics
Time frame: 30 days post-procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2026.
- Background: PubMed 33427321Brooks 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.
- Background: PubMed 26491480Qureshi 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.
- Background: PubMed 24888796Hong 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.
- Background: PubMed 31494373Brooks 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.
- Background: PubMed 2765833Athow 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Post-surgical drain and No post-surgical drain in people with Thyroglossal Duct Cysts, run by University of Rochester at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Hematoma (time frame: 30 days post-procedure). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07148895, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.