NCT05669196

Brief Summary

The most commonly treatment for early stage non-small cell lung cancer (NSCLC) is lobectomy. Different surgical interventions during lobectomy are thought to have different effects on respiratory functions and exercise capacities. The aim of this study was to evaluate respiratory muscle strength, functional exercise capacity, and diaphragmatic thickness in groups that underwent lobectomy with standard thoracotomy, muscle sparing thoracotomy, and video-assisted thoracic surgery (VATS).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

Study Start

First participant enrolled

January 4, 2021

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 7, 2021

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

December 27, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 19, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 30, 2022

Completed
Last Updated

December 30, 2022

Status Verified

November 1, 2022

Enrollment Period

11 months

First QC Date

October 19, 2022

Last Update Submit

December 27, 2022

Conditions

Video Assisted Thoracoscopic SurgeryThoracic SurgeryRespiratory Muscles

Keywords

Lung cancer, functional capacity

Outcome Measures

Primary Outcomes (4)

  • Respiratory muscle strength (inspiration) change

    Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values. Preoperative and postoperative value differences will be calculated.

    The day before the operation.

  • Respiratory muscle strength (inspiration) change

    Respiratory muscle strength will measure by measuring mouth pressure and using maximal inspiratory pressure (MIP) values. Preoperative and postoperative value differences will be calculated.

    15-20 days after discharge.

  • Respiratory muscle strength (expiration) change

    Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values. Preoperative and postoperative value differences will be calculated.

    The day before the operation.

  • Respiratory muscle strength (expiration) change

    Respiratory muscle strength will measure by measuring mouth pressure and using maximal expiratory pressure (MEP) values. Preoperative and postoperative value differences will be calculated.

    15-20 days after discharge.

Secondary Outcomes (20)

  • Functional exercise capacity

    The day before the operation.

  • Functional exercise capacity

    15-20 days after discharge.

  • Diaphragmatic thickness

    The day before the operation.

  • Diaphragmatic thickness

    15-20 days after discharge.

  • Postoperative Pulmonary Complication

    Postoperative first-fifth days.

  • +15 more secondary outcomes

Study Arms (3)

standard thoracotomy group

Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with standard thoracotomy

muscle sparing thoracotomy group

Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with muscle sparing thoracotomy

VATS group

Individuals who are between the ages of 18-75 and lung cancer patient, underwent lobectomy with video-assisted thoracic surgery

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals with lung cancer who met the inclusion criteria in the 18-75 age range participated in the study. According to the surgical intervention methods, the patients in our study; divided into three groups as standard thoracotomy, muscle sparing thoracotomy, and VATS.

You may qualify if:

  • Being a lung cancer patient scheduled for standard thoracotomy, muscle sparing thoracotomy, or lobectomy with VATS,
  • Being clinically stable,
  • Volunteering to participate in the study,
  • be between the ages of 18-75,
  • To be cooperative in the tests to be done.

You may not qualify if:

  • Having an orthopedic and neurological condition that prevents walking, - Having undergone any surgery on the thoracic wall,
  • Diagnosed with small cell lung cancer.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hacettepe University

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract NeoplasmsThoracic NeoplasmsNeoplasms by SiteNeoplasmsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Funda Sirakaya, MsC

    Hacettepe University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctorate student

Study Record Dates

First Submitted

October 19, 2022

First Posted

December 30, 2022

Study Start

January 4, 2021

Primary Completion

December 7, 2021

Study Completion

December 27, 2021

Last Updated

December 30, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)