Post-Surgical Drain for Thyroglossal Duct Cysts

Enrolling by invitation at 4 trial locations

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Rochester

Disqualifiers: Bleeding disorders, Immunodeficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how children recover after surgery for a neck lump known as a thyroglossal duct cyst. After surgery, some children receive a small tube called a drain to aid healing, while others do not (referred to as "no post-surgical drain"). The study aims to determine if using a drain reduces healing problems such as infections or the need for additional treatment. It seeks children undergoing this specific neck surgery to participate.

As an unphased trial, this study provides an opportunity to contribute to understanding the best post-surgical care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that using a post-surgical drain is safe for children undergoing the Sistrunk procedure?

Research has shown that using a drain during surgery for thyroglossal duct cysts might not reduce common postoperative problems. One study found that a drain did not significantly lower the risk of issues such as infections or the need for additional treatment. The most common problems after this surgery were unexpected additional surgeries and hospital readmissions.

Overall, using a drain is generally well-tolerated, but it might not significantly impact recovery. Researchers closely monitor participants for safety, recording any problems to ensure the highest level of safety. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores the possibility of eliminating the need for a post-surgical drain in the treatment of thyroglossal duct cysts. Traditionally, after the Sistrunk procedure, a suction drain is placed to manage fluid build-up and aid recovery. This trial investigates whether patients can recover just as well without this step, potentially offering a simpler and more comfortable post-surgical experience. By potentially reducing the need for drains, this approach could lead to faster recovery times and less discomfort for patients.

What evidence suggests that using a post-surgical drain could be effective for recovery after the Sistrunk procedure?

This trial will compare the use of a post-surgical drain with no drain during the Sistrunk procedure for thyroglossal duct cysts. Studies have shown that using a drain during the Sistrunk procedure might not reduce post-operative complications. Research indicates that placing a drain does not significantly lower the risk of infections or the need for additional procedures. One study found that having a drain did not reduce the chance of cyst recurrence. Overall, evidence suggests that using a drain might not improve healing in children after this surgery. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for children undergoing the Sistrunk procedure to remove a thyroglossal duct cyst. It aims to determine if placing a post-surgical drain affects recovery outcomes.

Inclusion Criteria

I was assigned to either the drain or no drain group during surgery.

Patient admitted for overnight observation

I am 18 years old or younger.

Exclusion Criteria

Patients with confirmed bleeding or immunodeficiency disorders as previously documented in electronic medical record

I had an infection during my surgery.

Lesions greater than 3cm on preoperative ultrasound or axial imaging

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Surgery

Participants undergo the Sistrunk procedure with or without a drain

1 day

1 visit (in-person)

Post-operative Monitoring

Doctors monitor healing and check for complications such as infections, hematoma, or seroma

30 days

Multiple visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• No post-surgical drain
• Post-surgical drain

Trial Overview

The study compares two groups of children after neck surgery: one group receives a drain and the other does not. The focus is on whether drains reduce complications or affect hospital return rates.

How Is the Trial Designed?

Group I: Drain Active Control 1 Intervention

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.

Group II: No Drain Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

University of Rochester

Lead Sponsor

Trials

883

Recruited

555,000+

Boston Children's Hospital

Collaborator

Trials

801

Recruited

5,584,000+

Keck School of Medicine of USC

Collaborator

Trials

7

Recruited

1,000+

Connecticut Children's Medical Center

Collaborator

Trials

76

Recruited

30,000+

Ann & Robert H Lurie Children's Hospital of Chicago

Collaborator

Trials

275

Recruited

5,182,000+

Children's Hospital Los Angeles

Collaborator

Trials

257

Recruited

5,075,000+

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6934095/

Current trends and 30-day surgical outcomes for thyroglossal ...

Identify current trends, adverse events, and clinical predictors in children treated with thyroglossal duct cyst surgery.

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0165587619303891

To drain or not to drain following a Sistrunk procedure

This dual institutional study found drain placement during a Sistrunk procedure may not reduce rates of common postoperative complications.

3.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/full/10.1002/lio2.1183

Risk‐adjusted analysis of perioperative outcomes after the ...

This study aimed to review our institution's outcomes following the Sistrunk procedure, specifically the rates of wound complications and cyst recurrence.

4.

jamanetwork.com

jamanetwork.com/journals/jamaotolaryngology/fullarticle/1106943

Impact of Incision and Drainage of Infected Thyroglossal ...

Incision and drainage of an infected TGDC may not increase the risk of postoperative recurrence. The results of this case series may assist in preoperative ...

5.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4593915/

Is There Any Benefit of Drain Placement on Postoperative ...

Surgical placement of a drain in the Sistrunk procedure does not seem to offer any advantage in terms of reducing common postoperative complications.

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07148895

Assessing Post-operative Outcomes After Children's ...

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 ...

7.

withpower.com

withpower.com/trial/phase-thyroglossal-cyst-9-2025-70ea8

Post-Surgical Drain for Thyroglossal Duct Cysts

It aims to determine if placing a post-surgical drain affects recovery outcomes. ... Participants are monitored for safety and effectiveness after the procedure.

8.

theajo.com

theajo.com/article/view/4070/html

Recurrent thyroglossal duct cysts: a 15-year review ...

We present a review of the presentation and management of recurrent TGDC over a 15-year period to assess trends and outcomes.