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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04931576
Other study ID # 2021-0316
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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