Clinical trial NCT04931576: No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)
Official title: The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Drainage
Thyroid Cancer
Keywords: Drainage
TOETVA
Palpilary Thyroid Carcinoma
complications
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-18
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence rate of hemorrhage on week 1 after surgery
timeFrame: 1 week
measure: The incidence rate of infections on week 2 after surgery
timeFrame: 2 week
measure: The incidence rate of postoperative hematoma or seroma on week 2 after surgery
timeFrame: 2 week
Secondary outcomes:
measure: Pain score on day 1 after surgery
timeFrame: 1 day
measure: Body temperature on day 1 after surgery
timeFrame: 1 day
measure: WBC on day 1 after surgery
timeFrame: 1 day
measure: CRP on day 1 after surgery
timeFrame: 1 week
measure: Length of post-operative hospital stay
timeFrame: 1 week
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital School of Medicine Zhejiang University
state: Zhejiang
Study officials:
References:
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.
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.
citation: 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.