Cross-sectional Case and Control Study on Quality of Life, Appearance and Functions in PTC Via Different Surgical Approach

July 5, 2023 updated by: Peking Union Medical College Hospital

The Effect of Postoperative Quality of Life and Cosmetic Result Between PTC Patients Underwent Thyroid Lobectomy Via Different Surgical Approach, Trans-axillary Approach vs Open Approach: A Cross-sectional Research

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Thyroid carcinoma is the most common thyroid tumor with a rising incidence. By 2015, it has risen to the fourth most common tumor among all tumors in female. Papillary thyroid carcinoma (PTC), representing up to 80% of all thyroid carcinomas, mostly occurring in female between 30-50 years old, although it has an excellent long-term survival outcome, still it brings the patients concerns and complaints of the obvious scars left on their necks by operations via traditional open approach. Cosmetic approaches of thyroid surgery have been developing rapidly in the last two decades, through approaches including trans-axillary, transoral, and trans-breast-chest, thyroid operations are able to avoid leaving surgical scars on the necks and instead leaving them on other parts of bodies covering by clothes. However, concerns of this new emerging technique including its excision extent, surgical complication, clinical outcome, functional outcome and postoperative quality of life still remain unsolved. Well-matched, high quality-studies focused on functional outcomes, cosmetic outcomes, and quality of life with large samples are still missing.

This observational cross-sectional case-control study with follow-up on the postoperative quality of life, clinical outcomes, functional outcomes and cosmetic outcomes of PTC patients underwent thyroid lobectomy via different approach, open vs trans-axillary, aims on achieving comprehensive understanding on how different surgical approaches affect the quality of life, clinical outcomes and functional outcomes. Patients are recruited in PUMCH from 2020-2023 who underwent thyroid lobectomy and with a definite pathological diagnosis of PTC. Cases are defined as PTC patients who underwent thyroid lobectomy via trans-axillary approach. Controls are defined as PTC patients who underwent thyroid lobectomy via open approach. Controls are matched to cases with a 1:1 ratio according to gender, age, main operator.

The postoperative quality of life, functional outcomes will be evaluated by a questionnaire made up of 4 validated scales (EORTC thyroid cancer specific quality of life questionnaire (THY34-QoL); patient scar assessment questionnaire (PSAQ); voice handicap index questionnaire (VHI-10); Swallowing impairment score (SIS-6). Clinical outcomes will be evaluated by data collected both from inpatient medical records and outpatient follow-up medical records. To our knowledge, this is the largest PTC thyroid lobectomy via trans-axillary approach case-control study worldwide, the first study with the design of assigning control matched to cases by applying pre-matching score method in this field, and the first study to concentrate on both clinical outcomes and comprehensive postoperative quality of life including physical, functional, and cosmetic outcomes in PTC patients via different surgical approaches.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China, 100730
        • Recruiting
        • Department of General Surgery, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Sciences
        • Contact:
          • Qiaofei Liu, MD
          • Phone Number: 86-15201693370

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Patient with PTC underwent 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
Patient with PTC underwent thyroid lobectomy via open approach

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cosmetic outcomes
Time Frame: up to 3 years after surgery
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thyroid cancer specific postoperative quality of life
Time Frame: up to 3 years after surgery
The thyroid cancer specific postoperative quality of life will be evaluated by scores of thyroid cancer specific quality of life 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 EORTC THY34-QoL scale. Scores will be compared in case and control groups. Higher scores in EORTC THY34-QoL indicate better quality of life.
up to 3 years after surgery
Voice outcomes
Time Frame: up to 3 years after surgery
The voice outcomes will be evaluated by scores of voice 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 VHI-10 scale. Scores will be compared in case and control groups. Lower scores in VHI-6 indicate poorer outcomes in this field.
up to 3 years after surgery
Swallowing function outcomes
Time Frame: up to 3 years after surgery
The swallowing function outcomes will be evaluated by scores of swallowing function outcome 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 SIS-6 scale. Scores will be compared in case and control groups. Lower scores in SIS-6 indicate poorer outcomes in swallowing function.
up to 3 years after surgery
Time to recurrence
Time Frame: up to 3 years after surgery
The time from the surgery to the recurrence (from date of surgery until the date of first documented recurrence including local recurrence, lymph node recurrence and distant metastasis).
up to 3 years after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Quan Liao, M.D, Department of General Surgery, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 25, 2023

Primary Completion (Estimated)

December 30, 2023

Study Completion (Estimated)

July 31, 2024

Study Registration Dates

First Submitted

June 24, 2023

First Submitted That Met QC Criteria

July 5, 2023

First Posted (Actual)

July 6, 2023

Study Record Updates

Last Update Posted (Actual)

July 6, 2023

Last Update Submitted That Met QC Criteria

July 5, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K4107-K23C1755

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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