Lung CancerQoLNCT04353349
Impact of Robotic Approach Compared to VATS and Open Approach on Quality of Life in Patients With Lung Cancer
An observational study of Lung Cancer and Robotic Thoracic Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
The aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (VATS) and the thoracotomic approach antero-lateral in patients with early stage lung cancer. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lung Cancer, Robotic Thoracic Surgery, Video-assisted Thoracis Surgery (VATS)
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- 1 Apr 2016to 1 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population should have the following Inclusion criteria: - known or suspected lung cancer clinical stage T1-T2, N0-N1 candidates for surgery lobectomy or anatomical segmentectomy; - ASA-1-2-3; - not severe heart disease; -no alcohol; -no renal impairment (creatinine <2); -not obese (BMI <30); no evidence of other serious comorbidities in the opinion of the investigator.
Who may be able to join
- known or suspected lung cancer clinical stage T1-T2;
- N0-N1 candidates for surgery lobectomy or anatomical segmentectomy;
- ASA-1-2-3;
- not severe heart disease;
- no alcohol;
- no renal impairment (creatinine <2);
- not obese (BMI <30);
- no evidence of other serious comorbidities in the opinion of the investigator.
Who cannot join
- severe heart disease;
- renal impairment (creatinine >2.5);
- evidence of any serious comorbidities according to the investigator;
- malignant tumor in the previous 2 years;
- previous chest surgery.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Minimally Invasive Robotic Approach Compared to VATS and Open Approach on Quality of Life and Immune Response in Patients Candidated to Lobectomy or Anatomical Segmentectomy
The aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (VATS) and the thoracotomic approach antero-lateral in patients with early stage lung cancer.
- Conditions
- Lung Cancer, Robotic Thoracic Surgery, Video-assisted Thoracis Surgery (VATS), Open Thoracotomy Surgery
- Keywords
- Robotic surgery, Lung cancer, Early stage, Quality of life, Post-operative pain
- Medical subject headings
- Lung Neoplasms, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients operated with an open approach | Not described | |
| Patients operated with minimally invasive robotic approach | Not described | |
| Patients operated with VATS approach | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of quality of life by EORTC QOL-CC30.
The sample size is calculated on the primary end point which is the prospective evaluation of quality of life (QoL) evolution after robotic-assisted thoracoscopic resection versus videothoracoscopic resection versus
open thoracotomy, with the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire-C30 and the lung cancer-specific module, LC-13.
51 patients operated in each group will provide 80% power to detect a 8-point difference in mean QLQ-C30 "Pain score" between any two study groups, at the 5% level of significance assuming a coefficient of variability of 0.5 and using a two-sided two-sample t-test. The scale parameters range are included from 1 (not at all) to 4 (very much).
Measured: 01/04/2016 - 01/12/2020
Secondary outcomes (4)
Evaluation of postoperative pain by daily evaluation with visual numeric scale before and after surgery until discharge and at 1, 6 and 12 months
Pain assessment will be recorded daily starting from the pre-operative day and post-operatively until discharge and subsequently at 2 weeks, 6 months and 12 months after surgery with numerical scale from 0 to 10 (ENV pain score); via questionnaire "Brief Pain Inventory".
A value of ENV ≤3 will be attributed to adequate analgesia; ENV a score of 4 to 6 will be considered inadequate analgesia with administration of analgesia as needed; ENV score ≥7 will be considered poor analgesia.
Measured: 01/04/2016 - 01/12/2020
Intraoperative complications
Conversion rate, defined as procedures that start with minimally invasive access and are converted to open surgery due to different reasons (bleeding, anatomical reasons, oncological reasons, technical reasons, other).
Measured: 01/04/2016 - 01/12/2020
Postoperative complications
Surgical complications, higher or equal grade II assessed by Clavien-Dindo scale, within 90 days.
Measured: 01/04/2016 - 01/12/2020
Disease free survival at 24 months
Disease free survival will be explored with survival analysis. The time will be calculated from the surgery data to the first recurrence date or to last contact date for all the patients free of disease at the end of surgery. Difference between groups will be explored with log-rank test.
Measured: 01/04/2016 - 01/12/2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2020
- Study start1 Apr 2016
- Primary completion1 Dec 2020 (estimated)
- Study completion1 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04353349
- Sponsor's protocol ID
- 1524
- Acronym
- QoL
- Status last verified
- Apr 2020
- First submitted
- 14 Apr 2020
- Last updated
- 20 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Minimally Invasive Robotic Approach Compared to VATS and Open Approach on Quality of Life and Immune Response in Patients Candidated to Lobectomy or Anatomical Segmentectomy
- ClinicalTrials.gov ID
- NCT04353349
- Acronym / sponsor ID
- QoL / 1524
- Conditions
- Lung Cancer, Robotic Thoracic Surgery, Video-assisted Thoracis Surgery (VATS), Open Thoracotomy Surgery
- Keywords
- Robotic surgery, Lung cancer, Early stage, Quality of life, Post-operative pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Dec 2020 (estimated)
- Study completion
- 1 Dec 2020 (estimated)
- First posted
- 20 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the study is to compare quality of life and early and late post-operative pain after anatomical lung resection (lobectomy or segmentectomy) performed by a robotic approach compared to the videothoracoscopic approach (VATS) and the thoracotomic approach antero-lateral in patients with early stage lung cancer.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Patients operated with an open approach | – | – |
| Patients operated with minimally invasive robotic approach | – | – |
| Patients operated with VATS approach | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population should have the following Inclusion criteria: - known or suspected lung cancer clinical stage T1-T2, N0-N1 candidates for surgery lobectomy or anatomical segmentectomy; - ASA-1-2-3; - not severe heart disease; -no alcohol; -no renal impairment (creatinine <2); -not obese (BMI <30); no evidence of other serious comorbidities in the opinion of the investigator.
Key inclusion criteria (8 listed)
- known or suspected lung cancer clinical stage T1-T2;
- N0-N1 candidates for surgery lobectomy or anatomical segmentectomy;
- ASA-1-2-3;
- not severe heart disease;
- no alcohol;
Key exclusion criteria (5 listed)
- severe heart disease;
- renal impairment (creatinine >2.5);
- evidence of any serious comorbidities according to the investigator;
- malignant tumor in the previous 2 years;
- previous chest surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluation of quality of life by EORTC QOL-CC30.
Time frame: 01/04/2016 - 01/12/2020
The sample size is calculated on the primary end point which is the prospective evaluation of quality of life (QoL) evolution after robotic-assisted thoracoscopic resection versus videothoracoscopic resection versus open thoracotomy, with the European Organisation for Research and Treatment of Cancer (EORTC) QoL Questionnaire-C30 and the lung cancer-specific module, LC-13. 51 patients operated in each group will provide 80% power to detect a 8-point difference in mean QLQ-C30 "Pain score" between any two study groups, at the 5% level of significance assuming a coefficient of variability of 0.5 and using a two-sided two-sample t-test. The scale parameters range are included from 1 (not at all) to 4 (very much).
4 secondary outcomes
Evaluation of postoperative pain by daily evaluation with visual numeric scale before and after surgery until discharge and at 1, 6 and 12 months
Time frame: 01/04/2016 - 01/12/2020
Intraoperative complications
Time frame: 01/04/2016 - 01/12/2020
Postoperative complications
Time frame: 01/04/2016 - 01/12/2020
Disease free survival at 24 months
Time frame: 01/04/2016 - 01/12/2020
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer and Robotic Thoracic Surgery, run by Istituto Clinico Humanitas at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of quality of life by EORTC QOL-CC30. (time frame: 01/04/2016 - 01/12/2020). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2020.