NCT05932121

Brief Summary

An observational cross-sectional case-control study on the postoperative quality of life (5 aspects, general quality of life, thyroid specific quality of life, scar appearance, voice and swallowing functions) of papillary thyroid carcinoma (PTC) patients underwent thyroid lobectomy via different approach, open vs trans-axillary. The patients are recruited in Peking Union Medical College Hospital (PUMCH) from 2020 to 2023 and are evaluated by follow-up with both outpatient visits and questionnaires made up of 9 validated scales.

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
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 24, 2023

Completed
1 day until next milestone

Study Start

First participant enrolled

June 25, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

July 6, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

July 6, 2023

Status Verified

June 1, 2023

Enrollment Period

6 months

First QC Date

June 24, 2023

Last Update Submit

July 5, 2023

Conditions

Papillary Thyroid CarcinomaThyroid Cancer

Keywords

Papillary thyroid carcinomaSurgical approachesVoice assessmentSwallowing assessmentCosmetic outcomesQuality of life

Outcome Measures

Primary Outcomes (1)

  • Cosmetic outcomes

    The primary outcome will be evaluated by scores of cosmetic outcomes of PTC patients underwent thyroid lobectomy via different surgical approach up to 3 years after surgery. The scores are evaluated by a follow-up questionnaire made up of cosmetic outcome via scale of PSAQ. Scores will be compared in case and control groups. Lower scores in PSAQ indicate poorer outcomes in this field.

    up to 3 years after surgery

Secondary Outcomes (4)

  • Thyroid cancer specific postoperative quality of life

    up to 3 years after surgery

  • Voice outcomes

    up to 3 years after surgery

  • Swallowing function outcomes

    up to 3 years after surgery

  • Time to recurrence

    up to 3 years after surgery

Study Arms (2)

PTC patients underwent thyroid lobectomy via trans-axillary approach

Case: PTC patients underwent thyroid lobectomy via trans-axillary approach.

Procedure: Thyroid lobectomy via trans-axillary approach

PTC patients underwent thyroid lobectomy via open approach

Controls: PTC patients underwent thyroid lobectomy via open approach.

Procedure: Thyroid lobectomy via open approach

Interventions

Thyroid lobectomy via trans-axillary approachPROCEDURE

Patient with PTC underwent thyroid lobectomy via trans-axillary approach

PTC patients underwent thyroid lobectomy via trans-axillary approach
Thyroid lobectomy via open approachPROCEDURE

Patient with PTC underwent thyroid lobectomy via open approach

PTC patients underwent thyroid lobectomy via open approach

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All of the hospitalized patients of PTC with a definite pathological diagnosis who underwent thyroid lobectomy via trans-axillary approach and those who underwent thyroid lobectomy via open approach matched by age, gender and major operator with a ratio of 1: 1 from 2020 to 2023 in Peking Union Medical College Hospital.

You may qualify if:

  • PTC patients underwent thyroid lobectomy with pathological diagnosis of PTC after surgery

You may not qualify if:

  • Refusal to participate; Patients with invalid or incomplete questionnaire results; Patients with another primary malignancy; Patients with severe immune disease or chronic disease accompanying with major organ failure.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100730, China

RECRUITING

MeSH Terms

Conditions

Thyroid Cancer, PapillaryThyroid Neoplasms

Condition Hierarchy (Ancestors)

Adenocarcinoma, PapillaryAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsEndocrine Gland NeoplasmsNeoplasms by SiteHead and Neck NeoplasmsEndocrine System DiseasesThyroid Diseases

Study Officials

  • Quan Liao, M.D

    Department of General Surgery, Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Qiaofei Liu, M.D

CONTACT

8615201693370qfliu@aliyun.com

Nan Huang, M.D

CONTACT

8618800195711nanhuang1992@gmail.com

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 24, 2023

First Posted

July 6, 2023

Study Start

June 25, 2023

Primary Completion

December 30, 2023

Study Completion

July 31, 2024

Last Updated

July 6, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)