Clinical trial NCT03479801: Comparative Study in Oral, Breast Approach and Open Thyroidectomy
Official title: Comparative Study of Surgical Results in Endoscopic Thyroidectomy Via Oral Approach, Via Breast Approach and Conventional Open Thyroidectomy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Thyroid Neoplasms
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2018-03-27
Enrollment: 150
Sex: ALL
Minimum age (years): 15
Maximum age (years): 55
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts about the eligibility criteria. Patients will be introduced the general information of different surgical methods, and the clinical studies.

Brief summary: Purpose: Total endoscopic thyroidectomy including oral approach and breast approach has excellent cosmetic and several functional results. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. The procedure of total endoscopic thyroidectomy by breast approach only left three incisions, while by oral approach did not leave any incisions in the body surface, which is scarless in the neck, involved with a higher cosmetic result. However, the long-term property evaluation of total endoscopic thyroidectomy was not confirmed. The purpose of our study was to evaluate the surgical results of total endoscopic thyroidectomy (transoral approach and breast approach) versus conventional open thyroidectomy.

Detailed description: Purpose: Total endoscopic thyroidectomy including oral approach and breast approach has excellent cosmetic and several functional results. Many patients, especially women, undergoing thyroid surgery are concerned about the postoperative cosmetic appearance of the neck. Transoral endoscopic thyroidectomy via vestibular approach (TOETVA) and endoscopic thyroidectomy via breast approach were routinely performed in our institute. The procedures of total endoscopic thyroidectomy by breast approach only left three incisions, while by oral approach did not leave any incisions in the body surface, which is scarless in the neck, involved with a higher cosmetic result. However, the comprehensive comparison between transoral approach, breast approach and conventional open method was not confirmed. The purpose of our study was to evaluate the surgical results of total endoscopic thyroidectomy (transoral approach and breast approach) versus conventional open thyroidectomy.

Eligibility criteria: Inclusion Criteria:

1. Age: 15\~55 years old;
2. Type: Differentiated thyroid carcinoma, diameter ≤ 2cm, cN0 or cN1a, M0;
3. Thyroid lobe was less than the second degree enlargement;
4. Thyroid benign goiter, and the diameter ≤ 6cm

Exclusion Criteria:

1. Combine the surgical history of mandibular, oral, facial, or neck;
2. It was shown by preoperative radiological examination that the thyroid cancer has local invasion, N1b, or distant metastasis.
3. Thyroid lobe was more than the third degree enlargement
4. Any medical history that probably interfere the test results or increase the disease risks
5. The patient's compliance is not very well, and cannot work as the doctors asked

Primary outcomes:
measure: Quality of life assessment postoperatively
timeFrame: 12 months after the surgery of thyroidectomy
Secondary outcomes:
measure: Cosmetic results of thyroidectomy postoperatively
timeFrame: 12 months after the surgery of thyroidectomy
measure: Surgical Complications of thyroidectomy postoperatively
timeFrame: 12 months after the surgery of thyroidectomy
measure: Surgical Completeness of thyroidectomy postoperatively
timeFrame: 12 months after the surgery of thyroidectomy
Other outcomes:
Locations:
city: Hanzhou
country: China
facility: SAHZhejiangU
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianan Wang, MD.
role: STUDY_DIRECTOR
References:
citation: Wang Y, Yu X, Wang P, Miao C, Xie Q, Yan H, Zhao Q, Zhang M, Xiang C. Implementation of Intraoperative Neuromonitoring for Transoral Endoscopic Thyroid Surgery: A Preliminary Report. J Laparoendosc Adv Surg Tech A. 2016 Dec;26(12):965-971. doi: 10.1089/lap.2016.0291. Epub 2016 Sep 1.