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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Routine application of drainage tube | No Intervention | After TOETVA, patients will receive one drainage tube through anterior cervical area. | |
| Omission of drainage tube | Experimental | After TOETVA, patients will receive complete omission of drianage tube and directly close the incision. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| no drainage tube applied | Procedure | No drainage tube implacement after TOETVA |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Li Zhiyu, Ph.D | Contact | +86-13858169479 | drlizy@163.com | |
| Zhang Jingying, Ph.D | Contact | +86-15068803975 | jyzhang_hz@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital School of Medicine Zhejiang University | Recruiting | Hangzhou | Zhejiang | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28715809 | Background | Schietroma M, Pessia B, Bianchi Z, De Vita F, Carlei F, Guadagni S, Amicucci G, Clementi M. Thyroid Surgery: To Drain or Not to Drain, That Is the Problem - A Randomized Clinical Trial. ORL J Otorhinolaryngol Relat Spec. 2017;79(4):202-211. doi: 10.1159/000464137. Epub 2017 Jul 15. | |
| 33022081 | Background | Soh TCF, Ong QJ, Yip HM. Complications of Neck Drains in Thyroidectomies: A Systematic Review and Meta-Analysis. Laryngoscope. 2021 Mar;131(3):690-700. doi: 10.1002/lary.29077. Epub 2020 Oct 6. |
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| ID | Term |
|---|---|
| D013964 | Thyroid Neoplasms |
| ID | Term |
|---|---|
| D004701 | Endocrine Gland Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
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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 |
| 31951503 | Background | Fernandez Ranvier G, Meknat A, Guevara DE, Llorente PM, Vidal Fortuny J, Sneider M, Chen YH, Inabnet W 3rd. International Multi-institutional Experience with the Transoral Endoscopic Thyroidectomy Vestibular Approach. J Laparoendosc Adv Surg Tech A. 2020 Mar;30(3):278-283. doi: 10.1089/lap.2019.0645. Epub 2020 Jan 17. |
| D004700 |
| Endocrine System Diseases |
| D013959 | Thyroid Diseases |