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

NCT07778485 | Not Yet Recruiting DMC

• 2 other identifiers: PHAnshun2An City Office [2026] No. 6
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Thyroglossal Cyst

Keywords

Thyroglossal Cyst Submental approach Efficacy study

Outcome Measures

Primary Outcomes (3)

• Perioperative Clinical Indicators

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

  Perioperative

• 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).

  up to 6 mouth

• 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.

  up to 72 hours

Secondary Outcomes (1)

• Total Postoperative Negative-Pressure Wound Drainage Volume

  up to Day 2

Study Arms (2)

Submental endoscopic-assisted Sistrunk operation

EXPERIMENTAL

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

Conventional open Sistrunk operation via cervical incision

ACTIVE COMPARATOR

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

Interventions

The experimental group PROCEDURE

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

Also known as: Submental endoscopic-assisted Sistrunk operation

Conventional open Sistrunk operation via cervical incision

In the control group OTHER

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

Submental endoscopic-assisted Sistrunk operation

Eligibility Criteria

• Age: 3 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• People's Hospital of Anshun City of Guizhou Province: lead

Related Publications (3)

• Rohof D, Honings J, Theunisse HJ, Schutte HW, van den Hoogen FJ, van den Broek GB, Takes RP, Wijnen MH, Marres HA. Recurrences after thyroglossal duct cyst surgery: Results in 207 consecutive cases and review of the literature. Head Neck. 2015 Dec;37(12):1699-704. doi: 10.1002/hed.23817. Epub 2014 Sep 25.

  PMID: 24985922 RESULT

• Ellis PD, van Nostrand AW. The applied anatomy of thyroglossal tract remnants. Laryngoscope. 1977 May;87(5 Pt 1):765-70. doi: 10.1002/lary.5540870512.

  PMID: 850454 RESULT

• Sistrunk WE. THE SURGICAL TREATMENT OF CYSTS OF THE THYROGLOSSAL TRACT. Ann Surg. 1920 Feb;71(2):121-122.2. doi: 10.1097/00000658-192002000-00002. No abstract available.

  PMID: 17864229 RESULT

MeSH Terms

Conditions

Thyroglossal Cyst

Condition Hierarchy (Ancestors)

Cysts; Neoplasms

Study Officials

• fei L Yue, PG

  People's Hospital of Anshun City of Guizhou Province

  STUDY DIRECTOR

Central Study Contacts

Guang J Tang, MD

CONTACT

86+ 13595302195; tgjdoctor@163.com

Xing Y Lan, MB

CONTACT

86+ 13595361911; lyxassymyy2022@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associate chief physician

Model Details: 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.

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): September 1, 2026
• Primary Completion (Estimated): June 30, 2028
• Study Completion (Estimated): June 30, 2028
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share