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Study on the Efficacy of Laparoscopic-Assisted Thyroglossal Duct Cyst Resection Via Submental Approach

NCT07778485 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-08-21

No results posted yet for this study

Summary

Thyroglossal duct cysts are congenital diseases of the neck. Once detected, surgical treatment is the first choice. The traditional Sistrunk surgery has definite efficacy but leaves scars on the neck. With the popularization of the concept of minimally invasive surgery, the non-inflated submandibular approach endoscopic technique provides a new idea for achieving a scar-free resection of the neck. This project intends to conduct a randomized controlled study to scientifically evaluate the clinical efficacy and safety of submandibular approach endoscopic-assisted resection of thyroglossal duct cysts.

The study plans to include 60 newly diagnosed patients, randomly divided into the experimental group (submandibular approach endoscopic resection of thyroglossal duct cysts) and the control group (traditional open surgery). Systematically compare the perioperative indicators (operation time, intraoperative blood loss, average hospital stay), postoperative pain (VAS score), complications (infection, recurrence, injury of the sublingual nerve), and incision satisfaction (Vancouver Scar Scale) between the two groups.

This project is expected to establish a standardized surgical procedure, verify the superiority of this technique in achieving a scar-free neck while ensuring complete resection of the lesion, provide evidence-based medical evidence for the promotion of scar-free surgery in the neck, and have both clinical innovation and social benefits.

Conditions

  • Thyroglossal Cyst

Interventions

PROCEDURE

The experimental group

After general anesthesia, the patient is placed in the supine position with the neck slightly extended. A concealed transverse skin incision of approximately 2-3 cm is made about 1 cm below the chin (submental area), following the natural skin creases. Through this incision, blunt dissection is performed in the subplatysmal plane to create a subcutaneous tunnel reaching the hyoid bone region. The operation is assisted by an endoscope with a suspended retractor system without gas insufflation, thus avoiding the risk of gas embolism. Under high-definition endoscopic visualization, the thyroglossal duct cyst, the middle segment of the hyoid bone, and the track of the thyroglossal duct are meticulously dissected and completely resected en bloc. Hemostasis is achieved carefully to preserve the recurrent laryngeal and hypoglossal nerves. The wound is thoroughly irrigated with normal saline. A closed suction drain is placed if necessary. The submental incision is closed with intradermal absor

OTHER

In the control group

Make an incision in the middle of the skin on the neck, cut through the skin and subcutaneous tissue, expose the tumor and the hyoid bone, and completely remove the thyroglossal

Sponsors & Collaborators

  • People's Hospital of Anshun City of Guizhou Province

    lead OTHER

Principal Investigators

  • fei L Yue, PG · People's Hospital of Anshun City of Guizhou Province

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
3 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-09-01
Primary Completion
2028-06-30
Completion
2028-06-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778485 on ClinicalTrials.gov