NCT06838728

Brief Summary

This study is a prospective research. This study aims to investigate and follow up patients who undergo open thyroidectomy in the Department of Breast and Thyroid Surgery at Shandong Provincial Hospital from January 2020 to December 2025. This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery. This study investigated whether the application of head mounted magnifying glasses had an impact on preoperative and postoperative changes in PTH levels through inter group and self pre - and post control, in order to verify the practical effectiveness of head mounted magnifying glasses in thyroid surgery and provide reasonable suggestions for the selection of subsequent surgical treatment methods.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
2,000

participants targeted

Target at P75+ for not_applicable

Timeline
1mo left

Started Jan 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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 Progress99%
Jan 2020Jun 2026

Study Start

First participant enrolled

January 1, 2020

Completed
5.1 years until next milestone

First Submitted

Initial submission to the registry

February 15, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Expected
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

6 years

First QC Date

February 15, 2025

Last Update Submit

February 20, 2025

Conditions

Thyroid Surgery

Keywords

thyroid cancerthyroid surgeryHead Mounted Magnifying Glasses

Outcome Measures

Primary Outcomes (2)

  • PTH level

    To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery, investigators examine changes in PTH levels before and after surgery.

    4 weeks

  • lymph nodes number

    To verify the practical effectiveness of wearing a magnifying glass in thyroid surgery, investigators follow up on the number of lymph nodes removed in the postoperative pathology report.

    2 weeks

Study Arms (2)

experimental group

EXPERIMENTAL

When the experimental group undergoes surgery, the surgeon uses a head mounted magnifying glass to assist in the surgical operation.

Device: Head Mounted Magnifying Glasses

control group

NO INTERVENTION

When the experimental group undergoes surgery, the surgeon don't use a head mounted magnifying glass to assist in the surgical operation.

Interventions

Head Mounted Magnifying GlassesDEVICE

This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used.

experimental group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • All cases were the first to undergo open thyroidectomy surgery.
  • All clinical data and research materials of the cases are complete.
  • All cases underwent thyroid function examination before and after surgery.
  • All cases in the experimental group were treated with a head mounted magnifying glass during surgery.

You may not qualify if:

  • Except for cases of recurrence.
  • Cases with incomplete clinical data and research materials are excluded.
  • Cases that have not undergone thyroid function tests before and after surgery are excluded.
  • Excluding cases of secondary surgery.
  • Excluding cases in the experimental group who did not use a head mounted magnifying glass during surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shandong Provincial Hospital

Jinan, Shandong, 250021, China

Location

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, OUTCOMES ASSESSOR
Masking Details
no other parties
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: This study was divided into an experimental group and a control group based on whether a head mounted magnifying glass was used, with the main calculation indicator being changes in PTH levels before and after surgery.
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
chief physician

Study Record Dates

First Submitted

February 15, 2025

First Posted

February 21, 2025

Study Start

January 1, 2020

Primary Completion

December 31, 2025

Study Completion (Estimated)

June 1, 2026

Last Updated

February 24, 2025

Record last verified: 2025-02

Locations

CN(1)