Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer

March 17, 2026 updated by: Sara Fra Fernandez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Living After Lung Surgery: Clinical Outcomes and Quality Of Life After Minimally Invasive Segmentectomy Versus Lobectomy for Lung Cancer

The goal is to compare patient reported outcomes, such as dyspnea, physical functioning and quality of life, between minimally invasive segmentectomy and lobectomy for stage I NSCLC during the first year after surgery.

The main questions it aims to answer are:

  • Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have less postoperative dyspnea than patients that undergo lobectomy?
  • Do patients with stage I NSCLC that undergo minimally invasive segmentectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo lobectomy?
  • Do patients with stage I NSCLC that undergo VATS segmentectomy or lobectomy have more favorable postoperative health related quality of life (HRQoL) than patients that undergo RATS segmentectomy or lobectomy?

Participants already undergoing surgical intervention as part of their regular medical care for resectable lung cancer will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

180

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

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.

Description

Inclusion Criteria:

  • Patients with clinical stage I NSCLC who undergo segmentectomy or lobectomy with VATS or RATS.

Exclusion Criteria:

  • Thoracic surgery in the previous year
  • Neoadyuvant treatment
  • Failure to complete preoperative questionnaires

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
Segmentectomy
Patients with cI NSLSC that undergo minimally invasive segmentectomy
Lobectomy
Patients with cI NSLSC that undergo minimally invasive lobectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative dyspnea
Time Frame: It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
The postoperative dyspnea score will be calculated from the 33-35 items of the EORTC QLQ-LC29 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Lung Cancer 29) questionnaire and standardized to a 0-100 score. These items assess dyspnoea in three modalities: during rest, walking and climbing stairs in the preceding week. In each setting dyspnea is quantified from 1 (not at all short or breath) to 4 (very much short of breath), therefore a higher score indicates a higher level of dyspnea.
It will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality-Adjusted Life Years (QALYs)
Time Frame: Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
Quality-adjusted life years (QALYs) will be calculated by combining survival with health-related quality of life measured using the EuroQol 5-Dimension ( EQ-5D) Questionnaire questionnaire at predefined follow-up time points. Utility scores derived from EQ-5D responses will be used to estimate QALYs using the area-under-the-curve method over the study period. Utility scores typically range from values below 0 (health states considered worse than death) to 1 (perfect health), with higher scores indicating better health status.
Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
Physical Functioning
Time Frame: Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.
Physical functioning will be assessed using the Physical Functioning scale of the EORTC QLQ-C30 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Core 30) questionnaire. This scale is calculated from items 1-5, which assess limitations in strenuous activities, walking long and short distances, the need to stay in bed or a chair during the day, and the need for assistance with basic daily activities. Scores are linearly transformed to a 0-100 scale according to the EORTC scoring manual, with higher scores indicating better physical functioning (100 = best functioning, 0 = worst).
Data will be collected preoperatively, at 1, 3, 6, and 12 months after surgery.

Collaborators and Investigators

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

Sponsor

Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Investigators

  • Principal Investigator: Sara Fra, MD, Hospital Universitario Ramón y Cajal

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 (Actual)

July 10, 2023

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

March 7, 2026

First Submitted That Met QC Criteria

March 12, 2026

First Posted (Actual)

March 17, 2026

Study Record Updates

Last Update Posted (Actual)

March 19, 2026

Last Update Submitted That Met QC Criteria

March 17, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 073/26

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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