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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age3-65
SponsorPeople's Hospital of Anshun City of Guizhou Province

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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;

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • The experimental group

    Procedure/Surgery

    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

  • In the control group

    Other intervention

    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

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Submental endoscopic-assisted Sistrunk operationExperimental treatment 1 intervention
Group B: Conventional open Sistrunk operation via cervical incisionActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Perioperative Clinical Indicators

Includes operation time (minutes), intraoperative blood loss (mL), and postoperative length of hospital stay (days).

Time frame
Perioperative
2

Vancouver Scar Scale (VSS) Score

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).

Time frame
up to 6 mouth
3

Pain Intensity assessed by Visual Analogue Scale (VAS)

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.

Time frame
up to 72 hours

Secondary outcomes

1

Total Postoperative Negative-Pressure Wound Drainage Volume

Total volume (mL) of fluid collected from the surgical site via closed suction drainage prior to drain removal.

Time frame
up to Day 2

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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