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No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

Primary Purpose

Drainage, Thyroid Cancer

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
no drainage tube applied
Sponsored by
Second Affiliated Hospital, School of Medicine, Zhejiang University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Drainage focused on measuring Drainage, TOETVA, Palpilary Thyroid Carcinoma, complications

Eligibility Criteria

18 Years - 55 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Second Affiliated Hospital School of Medicine Zhejiang UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Routine application of drainage tube

Omission of drainage tube

Arm Description

After TOETVA, patients will receive one drainage tube through anterior cervical area.

After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.

Outcomes

Primary Outcome Measures

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)
The incidence rate of infections on week 2 after surgery
To evaluate the incidence rate of infections of surgical sites
The incidence rate of postoperative hematoma or seroma on week 2 after surgery
To evaluate the incidence rate of postoperative hematoma or seroma

Secondary Outcome Measures

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.
Body temperature on day 1 after surgery
To evaluate the body temperature on day 1 after surgery.
WBC on day 1 after surgery
To evaluate the white blood count on day 1 after surgery.
CRP on day 1 after surgery
To evaluate the C-reaction protein on day 1 after surgery.
Length of post-operative hospital stay
To evaluate the length of post-operative hospital stay.

Full Information

First Posted
June 14, 2021
Last Updated
June 19, 2022
Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University
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1. Study Identification

Unique Protocol Identification Number
NCT04931576
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 1, 2023 (Anticipated)
Study Completion Date
October 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Second Affiliated Hospital, School of Medicine, Zhejiang University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Drainage, Thyroid Cancer
Keywords
Drainage, TOETVA, Palpilary Thyroid Carcinoma, complications

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
600 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Routine application of drainage tube
Arm Type
No Intervention
Arm Description
After TOETVA, patients will receive one drainage tube through anterior cervical area.
Arm Title
Omission of drainage tube
Arm Type
Experimental
Arm Description
After TOETVA, patients will receive complete omission of drianage tube and directly close the incision.
Intervention Type
Procedure
Intervention Name(s)
no drainage tube applied
Intervention Description
No drainage tube implacement after TOETVA
Primary Outcome Measure Information:
Title
The incidence rate of hemorrhage on week 1 after surgery
Description
To evaluate the incidence rate of postoperative hemorrhage (hemorrhage of surgical sites which requires reoperation)
Time Frame
1 week
Title
The incidence rate of infections on week 2 after surgery
Description
To evaluate the incidence rate of infections of surgical sites
Time Frame
2 week
Title
The incidence rate of postoperative hematoma or seroma on week 2 after surgery
Description
To evaluate the incidence rate of postoperative hematoma or seroma
Time Frame
2 week
Secondary Outcome Measure Information:
Title
Pain score on day 1 after surgery
Description
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.
Time Frame
1 day
Title
Body temperature on day 1 after surgery
Description
To evaluate the body temperature on day 1 after surgery.
Time Frame
1 day
Title
WBC on day 1 after surgery
Description
To evaluate the white blood count on day 1 after surgery.
Time Frame
1 day
Title
CRP on day 1 after surgery
Description
To evaluate the C-reaction protein on day 1 after surgery.
Time Frame
1 week
Title
Length of post-operative hospital stay
Description
To evaluate the length of post-operative hospital stay.
Time Frame
1 week

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Zhiyu, Ph.D
Phone
+86-13858169479
Email
drlizy@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Zhang Jingying, Ph.D
Phone
+86-15068803975
Email
jyzhang_hz@126.com
Facility Information:
Facility Name
Second Affiliated Hospital School of Medicine Zhejiang University
City
Hangzhou
State/Province
Zhejiang
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zhiyu Li
Email
zrlizy@zju.edu.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
28715809
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.
Results Reference
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PubMed Identifier
33022081
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.
Results Reference
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PubMed Identifier
31951503
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.
Results Reference
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No Drainage During Transoral Endoscopic Thyroidectomy Vestibular Approach(TOETVA)

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