NCT04931576

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2021

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

June 23, 2022

Status Verified

May 1, 2022

Enrollment Period

1.9 years

First QC Date

June 14, 2021

Last Update Submit

June 19, 2022

Conditions

DrainageThyroid Cancer

Keywords

DrainageTOETVAPalpilary Thyroid Carcinomacomplications

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (5)

  • Pain score on day 1 after surgery

    1 day

  • Body temperature on day 1 after surgery

    1 day

  • WBC on day 1 after surgery

    1 day

  • CRP on day 1 after surgery

    1 week

  • Length of post-operative hospital stay

    1 week

Study Arms (2)

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.

Procedure: no drainage tube applied

Interventions

no drainage tube appliedPROCEDURE

No drainage tube implacement after TOETVA

Omission of drainage tube

Eligibility Criteria

Age18 Years - 55 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Second Affiliated Hospital School of Medicine Zhejiang University

Hangzhou, Zhejiang, China

RECRUITING

Related Publications (3)

  • 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.

    PMID: 28715809BACKGROUND

  • 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.

    PMID: 33022081BACKGROUND

  • 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.

    PMID: 31951503BACKGROUND

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Central Study Contacts

Li Zhiyu, Ph.D

CONTACT

+86-13858169479drlizy@163.com

Zhang Jingying, Ph.D

CONTACT

+86-15068803975jyzhang_hz@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 14, 2021

First Posted

June 18, 2021

Study Start

July 1, 2021

Primary Completion

June 1, 2023

Study Completion

October 1, 2023

Last Updated

June 23, 2022

Record last verified: 2022-05

Locations

CN(1)