No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

Last updated: June 19, 2022
Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Thyroid Cancer

Treatment

N/A

Clinical Study ID

NCT04931576
2021-0316
  • Ages 18-55
  • Female

Study 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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  1. previous history of thyroid surgery;
  2. conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillaryapproach;
  3. patients undergoing cervical lateral lymph node dissection;
  4. past or current history of hyperthyroidism;
  5. history of combined hypertension, diabetes, coagulation dysfunction, or otherimportant organ dysfunction diseases.

Study Design

Total Participants: 600
Study Start date:
July 01, 2021
Estimated Completion Date:
October 01, 2023

Study 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.

Connect with a study center

  • Second Affiliated Hospital School of Medicine Zhejiang University

    Hangzhou, Zhejiang
    China

    Active - Recruiting

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