Drainage, Thyroid Cancer
Conditions
Keywords
Drainage, TOETVA, Palpilary Thyroid Carcinoma, complications
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.
Interventions
PROCEDUREno drainage tube applied
No drainage tube implacement after TOETVA
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| CRP on day 1 after surgery | 1 week | To evaluate the C-reaction protein on day 1 after surgery. |
| 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. |
| Length of post-operative hospital stay | 1 week | To evaluate the length of post-operative hospital stay. |
| Body temperature on day 1 after surgery | 1 day | To evaluate the body temperature on day 1 after surgery. |
| WBC on day 1 after surgery | 1 day | To evaluate the white blood count on day 1 after surgery. |
Countries
China
Contacts
Primary ContactLi Zhiyu, Ph.D
Backup ContactZhang Jingying, Ph.D
Outcome results
None listed