No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)
June 19, 2022 updated by: Second Affiliated Hospital, School of Medicine, Zhejiang University
The Feasibility of no Drainage During Transoral Endoscopic Thyroidectomy Via the Vestibular Approach in Treatment of Papillary Thyroid Carcinoma
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Anticipated)
600
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Li Zhiyu, Ph.D
- Phone Number: +86-13858169479
- Email: drlizy@163.com
Study Contact Backup
- Name: Zhang Jingying, Ph.D
- Phone Number: +86-15068803975
- Email: jyzhang_hz@126.com
Study Locations
-
-
Zhejiang
-
Hangzhou, Zhejiang, China
- Recruiting
- Second Affiliated Hospital School of Medicine Zhejiang University
-
Contact:
- Zhiyu Li
- Email: zrlizy@zju.edu.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Crossover Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Routine application of drainage tube
After TOETVA, patients will receive one drainage tube through anterior cervical area.
|
|
|
Experimental: Omission of drainage tube
After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.
|
No drainage tube implacement after TOETVA
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
The incidence rate of hemorrhage on week 1 after surgery
Time Frame: 1 week
|
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
Time Frame: 2 week
|
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
Time Frame: 2 week
|
To evaluate the incidence rate of postoperative hematoma or seroma
|
2 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain score on day 1 after surgery
Time Frame: 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.
|
1 day
|
|
Length of post-operative hospital stay
Time Frame: 1 week
|
To evaluate the length of post-operative hospital stay.
|
1 week
|
|
Body temperature on day 1 after surgery
Time Frame: 1 day
|
To evaluate the body temperature on day 1 after surgery.
|
1 day
|
|
WBC on day 1 after surgery
Time Frame: 1 day
|
To evaluate the white blood count on day 1 after surgery.
|
1 day
|
|
CRP on day 1 after surgery
Time Frame: 1 week
|
To evaluate the C-reaction protein on day 1 after surgery.
|
1 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2021
Primary Completion (Anticipated)
June 1, 2023
Study Completion (Anticipated)
October 1, 2023
Study Registration Dates
First Submitted
June 14, 2021
First Submitted That Met QC Criteria
June 14, 2021
First Posted (Actual)
June 18, 2021
Study Record Updates
Last Update Posted (Actual)
June 23, 2022
Last Update Submitted That Met QC Criteria
June 19, 2022
Last Verified
May 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2021-0316
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.