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

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

Status
Not yet recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07778485
Enrollment
60
Registered
2026-08-21
Start date
2026-09-01
Completion date
2028-06-30
Last updated
2026-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Thyroglossal Cyst

Keywords

Thyroglossal Cyst Submental approach Efficacy study

Brief 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.

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.

Interventions

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

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

People's Hospital of Anshun City of Guizhou Province
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Masking description

Given the inconsistency of the treatment methods in this trial, this project adopts a single-blind method (blindness for the patients). However, we will strictly adhere to the principle of separating the blind method from the research. Researchers who are not involved in the experiment will prepare the random table and assign the patients who meet the diagnostic criteria with the corresponding surgical treatment plan based on the order of their visits. During the experiment, the researchers conducting the study do not participate in the statistical analysis of the experimental data. The efficacy evaluation indicators will be evaluated by a third party, and the data statisticians will be blinded. The bottom of the blinding process is known only to the research designer and is kept confidential by a dedicated person.

Intervention model description

A prospective randomized controlled design was adopted. 60 patients with newly diagnosed primary thyroglossal duct cysts were planned to be included and randomly divided into the observation group and the control group, with 30 cases in each group. The experimental group would undergo a thyroid duct cyst resection surgery using the submental approach and laparoscopic assistance, while the control group would undergo the traditional Sistrunk open surgery. The perioperative indicators such as operation time, intraoperative blood loss, postoperative drainage volume, hospital stay, and postoperative visual analogue scale (VAS) score for pain were compared between the two groups. The results would be evaluated using statistics and the clinical application value of the minimally invasive surgical method would be comprehensively evaluated.

Eligibility

Sex/Gender
ALL
Age
3 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Perioperative Clinical IndicatorsPerioperativeIncludes operation time (minutes), intraoperative blood loss (mL), and postoperative length of hospital stay (days).
Vancouver Scar Scale (VSS) Scoreup to 6 mouthVSS 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).
Pain Intensity assessed by Visual Analogue Scale (VAS)up to 72 hoursA 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.

Secondary

MeasureTime frameDescription
Total Postoperative Negative-Pressure Wound Drainage Volumeup to Day 2Total volume (mL) of fluid collected from the surgical site via closed suction drainage prior to drain removal.

Contacts

CONTACTGuang J Tang, MD
tgjdoctor@163.com86+ 13595302195
CONTACTXing Y Lan, MB
lyxassymyy2022@163.com86+ 13595361911
STUDY_DIRECTORfei L Yue, PG

People's Hospital of Anshun City of Guizhou Province

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 22, 2026