No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Drainage, Thyroid Cancer

Intervention / Treatment
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* Procedure: no drainage tube applied


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients undergoing thyroid surgery for the first time The surgical method is TOETVA There is no lateral cervical lymph node metastasis assessed before surgery Fine-needle aspiration revealed palpilary thyroid carcinoma It meets the surgical indications and has no obvious surgical contraindications Exclusion Criteria: previous history of thyroid surgery; conventional open thyroidectomy, endoscopic thyroidectomy areola approach or axillary approach; patients undergoing cervical lateral lymph node dissection; past or current history of hyperthyroidism; history of combined hypertension, diabetes, coagulation dysfunction, or other important organ dysfunction diseases.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Routine application of drainage tube<br>After TOETVA, patients will receive one drainage tube through anterior cervical area. | |
| Experimental: Omission of drainage tube<br>After TOETVA, patients will receive complete omission of drianage tube and directly close the incision. | Procedure: no drainage tube applied<br>* No drainage tube implacement after TOETVA<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| The incidence rate of infections on week 2 after surgery | To evaluate the incidence rate of infections of surgical sites | 2 week | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body temperature on day 1 after surgery | To evaluate the body temperature on day 1 after surgery. | 1 day | 
| WBC on day 1 after surgery | To evaluate the white blood count on day 1 after surgery. | 1 day | 
| CRP on day 1 after surgery | To evaluate the C-reaction protein on day 1 after surgery. | 1 week | 
| Length of post-operative hospital stay | To evaluate the length of post-operative hospital stay. | 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Drainage, TOETVA, Palpilary Thyroid Carcinoma, complications