No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)
- Conditions
- Thyroid CancerDrainage
- Interventions
- Procedure: no drainage tube applied
- Registration Number
- NCT04931576
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief 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.
- Detailed 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 & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- 600
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Omission of drainage tube no drainage tube applied After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.
- Primary Outcome Measures
Name Time Method The incidence rate of hemorrhage on week 1 after surgery 1 week To evaluate the incidence rate of postoperative hemorrhage (hemorrhage of surgical sites which requires reoperation)
The incidence rate of infections on week 2 after surgery 2 week To evaluate the incidence rate of infections of surgical sites
The incidence rate of postoperative hematoma or seroma on week 2 after surgery 2 week To evaluate the incidence rate of postoperative hematoma or seroma
- Secondary Outcome Measures
Name Time Method Body temperature on day 1 after surgery 1 day To evaluate the body temperature on day 1 after surgery.
Length of post-operative hospital stay 1 week To evaluate the length of post-operative hospital stay.
Pain score on day 1 after surgery 1 day 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.
WBC on day 1 after surgery 1 day To evaluate the white blood count on day 1 after surgery.
CRP on day 1 after surgery 1 week To evaluate the C-reaction protein on day 1 after surgery.
Trial Locations
- Locations (1)
Second Affiliated Hospital School of Medicine Zhejiang University
🇨🇳Hangzhou, Zhejiang, China