No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

Thyroid Cancer Clinical Trial

Official title:

The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04931576
• Other study ID #: 2021-0316
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: October 1, 2023

Study information

• Verified date: May 2022
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Li Zhiyu, Ph.D
• Phone: +86-13858169479
• Email: drlizy[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the viability and safety of no drainage tube placement during transoral endoscopic thyroidectomy vestibular approach in treatment of patients with papillary thyroid carcinoma.

Description:

Transoral endoscopic thyroidectomy vestibular approach (TOETVA) is widely used due to its excellent cosmetic effect without scars on the body surface. In prevention of postoperative hemorrhage, a postoperative drainage tube is routinely placed in the surgical area. However, current opinion suggest that under the circumstance of strict and effective intraoperative hemostasis, routine application of drainage tube is unnecessary in conventional open thyroidectomy(COT). The research about drainage placement decision during endoscopic thyroidectomy is scarce currently. This study evaluates the viability and safety of no drainage tube placement during TOETVA on papillary thyroid carcinoma. Patients allocated to the intervention group will implace no drainage tube during TOETVA and those allocated in control group will implace one drainage tube routinely. The incidence of postoperative complications will be evaluated. The time of postoperative hospital-stay and operation time will be evaluated as well. At the same time, blood test results like WBC and CRP will be evaluated 1 day after surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

1. Patients undergoing thyroid surgery for the first time

2. The surgical method is TOETVA

3. There is no lateral cervical lymph node metastasis assessed before surgery

4. Fine-needle aspiration revealed palpilary thyroid carcinoma

5. It meets the surgical indications and has no obvious surgical contraindications

Exclusion Criteria:

1. previous history of thyroid surgery;

2. conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillary approach;

3. patients undergoing cervical lateral lymph node dissection;

4. past or current history of hyperthyroidism;

5. history of combined hypertension, diabetes, coagulation dysfunction, or other important organ dysfunction diseases.

Related Conditions & MeSH terms

• Drainage
• Thyroid Cancer
• Thyroid Diseases
• Thyroid Neoplasms

Intervention

Procedure:
• no drainage tube applied
No drainage tube implacement after TOETVA

Locations

Country	Name	City	State
China	Second Affiliated Hospital School of Medicine Zhejiang University	Hangzhou	Zhejiang

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

References & Publications (3)

Fernandez Ranvier G, Meknat A, Guevara DE, Llorente PM, Vidal Fortuny J, Sneider M, Chen YH, Inabnet W 3rd. International Multi-institutional Experience with the Transoral Endoscopic Thyroidectomy Vestibular Approach. J Laparoendosc Adv Surg Tech A. 2020 Mar;30(3):278-283. doi: 10.1089/lap.2019.0645. Epub 2020 Jan 17. — View Citation

Schietroma M, Pessia B, Bianchi Z, De Vita F, Carlei F, Guadagni S, Amicucci G, Clementi M. Thyroid Surgery: To Drain or Not to Drain, That Is the Problem - A Randomized Clinical Trial. ORL J Otorhinolaryngol Relat Spec. 2017;79(4):202-211. doi: 10.1159/000464137. Epub 2017 Jul 15. — View Citation

Soh TCF, Ong QJ, Yip HM. Complications of Neck Drains in Thyroidectomies: A Systematic Review and Meta-Analysis. Laryngoscope. 2021 Mar;131(3):690-700. doi: 10.1002/lary.29077. Epub 2020 Oct 6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence rate of hemorrhage on week 1 after surgery	To evaluate the incidence rate of postoperative hemorrhage (hemorrhage of surgical sites which requires reoperation)	1 week
Primary	The incidence rate of infections on week 2 after surgery	To evaluate the incidence rate of infections of surgical sites	2 week
Primary	The incidence rate of postoperative hematoma or seroma on week 2 after surgery	To evaluate the incidence rate of postoperative hematoma or seroma	2 week
Secondary	Pain score on day 1 after surgery	To evaluate the pain score via numerical rating scale on day 1 after surgery. An 11-point numeric scale (NRS 11) with 0 representing no pain and 10 representing worst pain imaginable.	1 day
Secondary	Body temperature on day 1 after surgery	To evaluate the body temperature on day 1 after surgery.	1 day
Secondary	WBC on day 1 after surgery	To evaluate the white blood count on day 1 after surgery.	1 day
Secondary	CRP on day 1 after surgery	To evaluate the C-reaction protein on day 1 after surgery.	1 week
Secondary	Length of post-operative hospital stay	To evaluate the length of post-operative hospital stay.	1 week