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

August 19, 2026 updated by: Guangjun Tang, People's Hospital of Anshun City of Guizhou Province

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

1. Project-defined project goals and task requirements analysis 1.1 Project Goals 1.1.1 Overall Goal This project aims to conduct a prospective randomized controlled study to scientifically evaluate the clinical efficacy and safety of endoscopic-assisted thyroglossal duct cyst resection through an un-inflated submental approach, establish a standardized surgical procedure, and provide evidence-based medical evidence for the promotion of minimally invasive surgery with no neck scars.

1.1.2 Specific Goals 1.1.2.1 Efficacy Verification Goal Compare the differences in surgical time, intraoperative blood loss, hospital stay, and postoperative pain between the submental approach endoscopic surgery and the traditional Sistrunk surgery.

1.1.2.2 Safety Assessment Goal Monitor the incidence of complications and the 1-year recurrence rate of the two groups, ensuring that the recurrence rate of the observation group is controlled within 5% .

1.1.2.3 Aesthetic Effect Evaluation Goal Use the Vancouver Scar Scale (VSS) to evaluate the aesthetic appearance of the incision at 1, 3, and 6 months after surgery.

1.1.2.4 Technical Standardization Goal Summarize the key technical points and form a standardized surgical operation procedure.

1.2. Task Requirements Analysis 1.2.1 Clinical Requirements Thyroglossal duct cysts account for 75% of the spectrum of congenital diseases in the neck. Although the traditional Sistrunk surgery reduces the recurrence rate to below 5%, it leaves scars on the neck, causing psychological burden to patients. Therefore, a treatment plan that balances cure and aesthetics urgently needs to be established.

1.2.2 Technical Requirements The existing endoscopic approaches through the mouth, chest, and breast have high infection risks, large trauma range, and require inflation. The un-inflated submental approach utilizes the natural skin creases under the chin, has a short path, can directly handle the hyoid bone, and combines aesthetics with safety. However, it lacks large-sample randomized controlled studies for verification.

1.2.3 Evidence-Based Requirements Most existing studies are small-sample case reports and lack high-quality controlled studies [2]. Conducting rigorous randomized controlled trials to systematically compare the efficacy, safety, and aesthetic effects of the two surgical methods is an urgent need to promote clinical application.

1.2.4 Social Benefit Requirements Neck scars affect patients' self-confidence and quality of life. Achieving no-neck scars is an embodiment of the medical model's shift towards "physical and mental rehabilitation", with good social benefits and promotion prospects.

2 Project Objectives and Main Technical Difficulties and Issues in Task Resolution 2.1 Technical Difficulties in Laryngeal Bone Handling under Endoscopy 2.1.1 Description of the Difficulties The recurrence rate can be as high as 50% if the laryngeal bone is not handled thoroughly. Under the endoscopic view, the laryngeal bone is located deep within and has a hard texture. The primary difficulty is to precisely disarticulate it while avoiding damage to the hypoglossal nerve and the superior laryngeal nerve.

2.1.2 Solution Ideas Preoperative CT three-dimensional reconstruction is used to predict the resection range; during the operation, an ultrasonic bone knife is used for precise disarticulation; the "five-step method" is adopted as the standard operating procedure; intraoperative nerve monitoring is used to assist in protecting the nerves.

2.2 Narrow Operating Space and Difficulties in Field Exposure 2.2.1 Description of the Difficulties There are no natural cavities in the neck, and the small incision under the chin placed with the endoscope leads to the "chopstick effect". The cyst is located below the laryngeal bone, and the field exposure is difficult.

2.2.2 Solution Ideas The non-inflated suspension method is used to establish the operating space; specialized and elongated endoscopic instruments are modified; the suspension tension is dynamically adjusted; the indications are strictly selected, excluding cases with a diameter > 4 cm or those in the infectious stage.

2.3 Identification and Protection of Important Nerves and Blood Vessels 2.3.1 Description of the Difficulties The submandibular area involves the hypoglossal nerve, superior laryngeal nerve, etc. The identification is difficult under the two-dimensional endoscopic view, and incorrect injury can lead to serious complications.

2.3.2 Solution Ideas The nerve is located by using the digastric muscle and masseter muscle as references ; the surgical field is kept blood-free; postoperative close observation of swallowing and speech functions is conducted.

2.4 Learning Curve and Standardization of Surgical Procedure 2.4.1 Description of the Difficulties The surgeon needs to have both open surgery experience and endoscopic skills. The initial operation time is longer (median 135 minutes), and there is a possibility of conversion to open surgery.

2.4.2 Solution Ideas Conduct anatomical training and simulation operations; formulate standardized surgical procedures; initially operated by experienced physicians; regularly analyze and summarize to continuously optimize.

2.5 Objective Evaluation of Aesthetic Effect 2.5.1 Description of the Difficulties Scar evaluation is subjective. How to objectively quantify the aesthetic effect is a research design difficulty.

2.5.2 Solution Ideas The Vancouver Scar Scale (VSS) is used to score from four dimensions: color, thickness, vascular distribution, and softness; combined with patient satisfaction VAS evaluation; third-party blind assessment is conducted.

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • The cyst is in the non-acute infection stage;

    • The cyst has not ruptured to form a skin sinus tract or fistula;

      • Preoperative B-ultrasound and CT indicated that it was a thyroglossal duct cyst;

        • There are no severe underlying heart or lung diseases or coagulation dysfunction;

          • The patient and their family voluntarily chose to undergo laparoscopic resection of the thyroglossal duct cyst; ⑥ The patient and their family voluntarily signed the informed consent form.

Exclusion Criteria:

  • The cyst is in the acute infection stage;

    • The cyst ruptures, forming a skin sinus tract or fistula; ③ Has severe underlying heart and lung diseases and coagulation dysfunction; ④ Those with cyst diameters greater than 4 cm; ⑤ Those currently participating in other research studies.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Submental endoscopic-assisted Sistrunk operation
After general anesthesia, the patient lies in a supine position with the neck slightly extended backward. A concealed incision of approximately 2-3 centimeters in length is made along the natural skin fold at about 1 centimeter below the chin (the submental area). Through this incision, a blunt dissection is performed at the subcutaneous thin muscle layer level to form a subcutaneous tunnel that extends directly to the thyroid cartilage region. The surgery is assisted by an endoscope with a suspension and traction system and without the need for inflation. Under high-definition endoscopic visualization, the thyroglossal duct cyst, the middle segment of the hyoid bone, and the path of the thyroglossal duct are carefully separated and completely resected. A closed drainage tube is placed. The submental incision is sutured using absorbable sutures within the dermis.
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
Active Comparator: Conventional open Sistrunk operation via cervical incision
After general anesthesia, the patient is placed in the supine position with the neck extended. A horizontal skin incision is made along the midline of the neck directly over the thyroglossal duct cyst. The skin and subcutaneous tissues are divided. The strap muscles (sternohyoid and thyrohyoid) are separated in the midline to expose the cyst and the body of the hyoid bone. The thyroglossal duct cyst is dissected en bloc together with the central portion of the hyoid bone, preserving the surrounding vital structures. The surgical wound is thoroughly irrigated with normal saline. The incision is closed in layers with absorbable sutures, and a sterile dressing is applied.
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 Names:
  • Submental endoscopic-assisted Sistrunk operation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perioperative Clinical Indicators
Time Frame: Perioperative
Includes operation time (minutes), intraoperative blood loss (mL), and postoperative length of hospital stay (days).
Perioperative
Vancouver Scar Scale (VSS) Score
Time Frame: up to 6 mouth
VSS evaluates scars across 4 subscales: pigmentation, thickness, vascularity, and pliability. Subscale scores are summed to generate a total score (range 0-15, with higher scores reflecting more severe scarring).
up to 6 mouth
Pain Intensity assessed by Visual Analogue Scale (VAS)
Time Frame: up to 72 hours
A 10-cm horizontal line anchored by 0 (no pain) and 10 (worst imaginable pain). Participants mark a point corresponding to their current pain level. Higher scores indicate worse pain.
up to 72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total Postoperative Negative-Pressure Wound Drainage Volume
Time Frame: up to Day 2
Total volume (mL) of fluid collected from the surgical site via closed suction drainage prior to drain removal.
up to Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

People's Hospital of Anshun City of Guizhou Province

Investigators

  • Study Director: fei L Yue, PG, People's Hospital of Anshun City of Guizhou Province

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2026

Primary Completion (Estimated)

June 30, 2028

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

July 8, 2026

First Submitted That Met QC Criteria

August 19, 2026

First Posted (Actual)

August 21, 2026

Study Record Updates

Last Update Posted (Actual)

August 21, 2026

Last Update Submitted That Met QC Criteria

August 19, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PHAnshun2
  • An City Office [2026] No. 6 (Other Grant/Funding Number: Anshun Municipal Bureau of Science and Technology)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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