Thyroid Cancer Clinical Trial
Official title:
The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma
NCT number | NCT04931576 |
Other study ID # | 2021-0316 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 1, 2021 |
Est. completion date | October 1, 2023 |
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.
Status | Recruiting |
Enrollment | 600 |
Est. completion date | October 1, 2023 |
Est. primary completion date | June 1, 2023 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 55 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
China | Second Affiliated Hospital School of Medicine Zhejiang University | Hangzhou | Zhejiang |
Lead Sponsor | Collaborator |
---|---|
Second Affiliated Hospital, School of Medicine, Zhejiang University |
China,
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. — View Citation
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. — View Citation
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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | The incidence rate of infections on week 2 after surgery | To evaluate the incidence rate of infections of surgical sites | 2 week | |
Primary | 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 | 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 | |
Secondary | Body temperature on day 1 after surgery | To evaluate the body temperature on day 1 after surgery. | 1 day | |
Secondary | WBC on day 1 after surgery | To evaluate the white blood count on day 1 after surgery. | 1 day | |
Secondary | CRP on day 1 after surgery | To evaluate the C-reaction protein on day 1 after surgery. | 1 week | |
Secondary | Length of post-operative hospital stay | To evaluate the length of post-operative hospital stay. | 1 week |
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