NCT03577951

Brief Summary

Patients in our department endoscopic thyroidectomy were randomly divided into high position and low position established operating space group established operating space group. The thyroid size, patient BMI, operation time, and intraoperative blood loss were compared between the two groups.

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
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2018

Shorter than P25 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

Study Start

First participant enrolled

June 1, 2018

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

June 24, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 5, 2018

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2018

Completed
Last Updated

September 18, 2018

Status Verified

September 1, 2018

Enrollment Period

3 months

First QC Date

June 24, 2018

Last Update Submit

September 17, 2018

Conditions

Thyroid CancerEndoscopy

Outcome Measures

Primary Outcomes (2)

  • Intercostal arterial bleeding

    The number of intercostal artery bleeding

    During surgery

  • Thyroidectomy time

    Time to complete removal of thyroid gland specimens starting from the establishment of the operating space (minutes)

    During surgery

Secondary Outcomes (3)

  • Thyroid volume

    Before surgery

  • Patient's BMI

    Before surgery

  • Assessment of skin sensory abnormalities

    two months after surgery

Study Arms (2)

high position space group

EXPERIMENTAL

The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.

Procedure: high position space group

low position space group

EXPERIMENTAL

The left and right Trocar meet under the sternum angle and begin to establish the operating space.

Procedure: low position space group

Interventions

high position space groupPROCEDURE

The left and right Trocar meet at the level of the sternum angle and begin to establish the operating space.

high position space group
low position space groupPROCEDURE

The left and right Trocar meet under the sternum angle and begin to establish the operating space.

low position space group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with endoscopic thyroid surgery
  • No previous neck surgery

You may not qualify if:

  • Patients undergoing lateral neck lymph node dissection during the same period

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fujian Medical University Union Hospital

Fuzhou, Fujian, 350001, China

RECRUITING

MeSH Terms

Conditions

Thyroid Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Professor

Study Record Dates

First Submitted

June 24, 2018

First Posted

July 5, 2018

Study Start

June 1, 2018

Primary Completion

August 31, 2018

Study Completion

October 31, 2018

Last Updated

September 18, 2018

Record last verified: 2018-09

Locations

CN(1)