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Drain or no drain? new study aims to improve Kids' neck surgery recovery

NCT ID NCT07148895

Knowledge-focused Sponsor: University of Rochester Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only This study
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 10, 2026 · Updated 2 times

Summary

This study looks at children having surgery to remove a common neck lump called a thyroglossal duct cyst. Some kids will have a small drain placed during surgery, and some will not. The goal is to see if using a drain reduces problems like infection, fluid buildup, or the need for extra procedures. About 178 children will take part to help doctors learn the best way to recover.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 178 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2026

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

3 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

familial thyroglossal duct cyst thyroglossal duct cyst

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Thyroglossal duct cysts

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    5 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

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

    Chicago, Illinois, 60611, United States

  • Boston Children's Hospital

    Boston, Massachusetts, 02115, United States

  • Children's Hospital Los Angeles

    Los Angeles, California, 90027, United States

  • Connecticut Children's

    Hartford, Connecticut, 06107, United States

  • University of Rochester Medical Center

    Rochester, New York, 14642, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.