No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

Zhejiang University

Status: Unknown

Conditions: Thyroid Cancer; Drainage

Treatments: Procedure: no drainage tube applied

Study type: Interventional

Funder types: Other

Identifiers

NCT04931576

2021-0316

Details and patient eligibility

About

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.

Full 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.

Enrollment: 600 estimated patients

Sex: Female

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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600 participants in 2 patient groups

Routine application of drainage tube

No Intervention group

Description:

After TOETVA, patients will receive one drainage tube through anterior cervical area.

Omission of drainage tube

Experimental group

Description:

After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.

Treatment:

Procedure: no drainage tube applied