Clinical trial · Interventional

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

NCT07778485CI-TRIAL-00123317not yet recruitingN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Thyroglossal Cyst	—	UNRESOLVED	—

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
In the control group	Other	—	UNRESOLVED
The experimental group	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Submental endoscopic-assisted Sistrunk operation
description
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.
interventionNames
1. Other: In the control group
type
ACTIVE_COMPARATOR
label
Conventional open Sistrunk operation via cervical incision
description
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.

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 3 Years
Maximum age: 65 Years

Show eligibility criteria text

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.

References

Publications (3)

RESULTRohof 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
RESULTEllis 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
RESULTSistrunk 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