Non-small Cell Lung CancerNCT02617186
Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: RCT
A study testing Video-assisted thoracoscopic surgery and Robotic thoracic surgery in people with Non-small Cell Lung Cancer and Thoracic Surgery, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial summary
During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-small Cell Lung Cancer, Thoracic Surgery
- What is being tested?
- Video-assisted thoracoscopic surgery and Robotic thoracic surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 446 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2016to Sep 2031
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >/= 18 years
- Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
- Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.
Who cannot join
- Clinical stage IIIb or IV NSCLC
- Not a candidate for minimally invasive surgery.
Trial locations and contacts
1 site in 1 country.
Canada1 site
McMaster University / St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
About this study
Official title: Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: A Randomized Controlled Trial
During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner.
There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer.
Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.
- Conditions
- Non-small Cell Lung Cancer, Thoracic Surgery
- Being tested
- Video-assisted thoracoscopic surgery, Robotic thoracic surgery
- Medical subject headings
- Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Video-assisted thoracoscopic surgeryProcedure or surgery
patients randomized to this arm will receive video-assisted thoracic surgery (VATS)
Robotic thoracic surgeryProcedure or surgery
patients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot
| Study group | Role | What they receive |
|---|---|---|
| Thoracoscopic Lobectomy | Active comparator | Not described Receives: Procedure: Video-assisted thoracoscopic surgery |
| Robotic Lobectomy | Active comparator | Not described Receives: Procedure: Robotic thoracic surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in HRQOL scores at week 12 between the treatment groups
Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.
Measured: 12 weeks post-surgery
Secondary outcomes (21)
Short-term clinical outcome differences
Clinical staging will be determined from diagnostic imaging reports
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Pathological staging will be determined from pathology report
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Number of lymph nodes sampled
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Admission date
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Date of surgery
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Discharge date
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Chest tube removal date
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Intraoperative blood loss
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Post-operative analgesia will be determined from list of prescribed pain medications
Measured: 3 weeks post-surgery
Short-term clinical outcome differences
Post-surgical pain will be determined from the Numeric Pain Rating Scale
Measured: 3 weeks post-surgery
Resource utilization
Operating room time
Measured: 1 year post-surgery
Resource utilization
Operating room staff
Measured: 1 year post-surgery
Resource utilization
Surgical instruments and consumables
Measured: 1 year post-surgery
Resource utilization
Admission to critical care beds
Measured: 1 year post-surgery
Resource utilization
Hospital length of stay
Measured: 1 year post-surgery
Resource utilization
Duration of intravenous analgesia
Measured: 1 year post-surgery
Resource utilization
Postoperative complications
Measured: 1 year post-surgery
Resource utilization
Costs associated with chronic post-surgical pain up to one year after surgery.
Measured: 1 year post-surgery
Cost Effectiveness
The incremental cost per quality-adjusted life year (QALY) gained will be calculated to assess cost effectiveness.
Measured: 5 years post-surgery
Difference in HRQOL scores between the treatment groups
Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at weeks 3 and 7; months 6, 12, 18, 24; and years 3, 4, and 5, which coincide with the intervals of oncological surveillance.
Measured: 3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery
Difference in 5-year survival rate between the two groups
Difference in 5-year survival rate between the two groups.
Measured: 5 years post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2015 (estimated)
- Study startJan 2016
- Primary completionSep 2021
- Study completionSep 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Non-small Cell Lung CancerStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 446 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Collaborators
- University of Toronto, University of Florida, University Hospital, Rouen, St Vincent's Hospital Melbourne, University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia), University of Melbourne / Barwon Health (Geelong, Australia)
- Responsible party
- Principal investigator, Wael Hanna, McMaster University
- Investigators
- Waël C Hanna, MDCM, MBA, FRCSC, Principal investigator, McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02617186
- Sponsor's protocol ID
- BFCRS-RP-003-1508-31
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2015
- Last updated
- 12 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Grogan EL, Jones DR. VATS lobectomy is better than open thoracotomy: what is the evidence for short-term outcomes? Thorac Surg Clin. 2008 Aug;18(3):249-58. doi: 10.1016/j.thorsurg.2008.04.007.
PubMed 18831499Onaitis MW, Petersen RP, Balderson SS, et al. Thoracoscopic Lobectomy Is a Safe and Versatile Procedure. Transactions of the Meeting of the American Surgical Association. 2006;124:86-91. doi:10.1097/01.sla.0000234892.79056.63.
Veronesi G. Robotic thoracic surgery: technical considerations and learning curve for pulmonary resection. Thorac Surg Clin. 2014 May;24(2):135-41, v. doi: 10.1016/j.thorsurg.2014.02.009.
PubMed 24780416Nasir BS, Bryant AS, Minnich DJ, Wei B, Cerfolio RJ. Performing robotic lobectomy and segmentectomy: cost, profitability, and outcomes. Ann Thorac Surg. 2014 Jul;98(1):203-8; discussion 208-9. doi: 10.1016/j.athoracsur.2014.02.051. Epub 2014 May 1.
PubMed 24793685Park BJ, Melfi F, Mussi A, Maisonneuve P, Spaggiari L, Da Silva RK, Veronesi G. Robotic lobectomy for non-small cell lung cancer (NSCLC): long-term oncologic results. J Thorac Cardiovasc Surg. 2012 Feb;143(2):383-9. doi: 10.1016/j.jtcvs.2011.10.055. Epub 2011 Nov 20.
PubMed 22104677Wei B, D'Amico TA. Thoracoscopic versus robotic approaches: advantages and disadvantages. Thorac Surg Clin. 2014 May;24(2):177-88, vi. doi: 10.1016/j.thorsurg.2014.02.001.
PubMed 24780422Louie BE, Farivar AS, Aye RW, Vallieres E. Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg. 2012 May;93(5):1598-604; discussion 1604-5. doi: 10.1016/j.athoracsur.2012.01.067. Epub 2012 Mar 20.
PubMed 22440364Kent M, Wang T, Whyte R, Curran T, Flores R, Gangadharan S. Open, video-assisted thoracic surgery, and robotic lobectomy: review of a national database. Ann Thorac Surg. 2014 Jan;97(1):236-42; discussion 242-4. doi: 10.1016/j.athoracsur.2013.07.117. Epub 2013 Oct 1.
PubMed 24090577Paul S, Jalbert J, Isaacs AJ, Altorki NK, Isom OW, Sedrakyan A. Comparative effectiveness of robotic-assisted vs thoracoscopic lobectomy. Chest. 2014 Dec;146(6):1505-1512. doi: 10.1378/chest.13-3032.
PubMed 24810546Hanna, WC., Fahim, C., Patel, P., Shargall, Y., Waddell TK., Yasufuku, K. (2015). Robotic Pulmonary Resection for Lung Cancer: The First Canadian Series. Abstract Accepted for podium presentation at Canadian Association of Thoracic Surgeons (CATS) 18th Annual Meeting, September 17-20, Quebec, QC.
Merritt RE, Hoang CD, Shrager JB. Lymph node evaluation achieved by open lobectomy compared with thoracoscopic lobectomy for N0 lung cancer. Ann Thorac Surg. 2013 Oct;96(4):1171-1177. doi: 10.1016/j.athoracsur.2013.05.044. Epub 2013 Jul 31.
PubMed 23915591D'Amico TA, Niland J, Mamet R, Zornosa C, Dexter EU, Onaitis MW. Efficacy of mediastinal lymph node dissection during lobectomy for lung cancer by thoracoscopy and thoracotomy. Ann Thorac Surg. 2011 Jul;92(1):226-31; discussion 231-2. doi: 10.1016/j.athoracsur.2011.03.134.
PubMed 21718849Research Electronic Data Capture (RedCap). http://www.project-redcap.org
Cerfolio RJ. Total port approach for robotic lobectomy. Thorac Surg Clin. 2014 May;24(2):151-6, v. doi: 10.1016/j.thorsurg.2014.02.006.
PubMed 24780418EuroQol Group. EuroQol--a new facility for the measurement of health-related quality of life. Health Policy. 1990 Dec;16(3):199-208. doi: 10.1016/0168-8510(90)90421-9.
PubMed 10109801
Study at a glance
From the registry record, last updated by the sponsor on 12 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Robotic Lobectomy vs. Thoracoscopic Lobectomy for Early Stage Lung Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02617186
- Acronym / sponsor ID
- BFCRS-RP-003-1508-31
- Conditions
- Non-small Cell Lung Cancer, Thoracic Surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 446 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Collaborators
- University of Toronto, University of Florida, University Hospital, Rouen, St Vincent's Hospital Melbourne, University of Melbourne / St. Vincent's Private Hospital (Fitzroy, Australia), University of Melbourne / Barwon Health (Geelong, Australia)
- Study start
- Jan 2016
- Primary completion
- Sep 2021 (actual)
- Study completion
- Sep 2031 (estimated)
- First posted
- 30 Nov 2015 (estimated)
- 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.
During video-assisted thoracoscopic lobectomy (VATS), the surgeon inserts a small camera attached to a thoracoscope that puts the image onto a video screen. Instruments are inserted via small incisions, and the lung resection is completed. Robotic thoracic surgery (RTS) uses a similar minimally invasive approach, but the very precise instruments involved with RTS allow the surgeon to view the lung using 3-dimensional imaging. The instruments give the surgeons increased range of motion during the surgery, and research demonstrates that RTS has a less steep learning curve as compared to VATS. Both VATS and RTS demonstrated better results as compared to traditional thoracotomy (open surgery). However, Robotic lobectomy has not yet been compared directly to video-assisted thoracoscopic lobectomy (VATS) in a prospective manner.
There are two major barriers against the widespread adoption of robotic thoracic surgery. The first barrier is the lack of high-quality prospective data. To our knowledge, there are no prospective trials comparing VATS to RTS for early stage lung cancer. The second major barrier to the widespread adoption of robotic technology in thoracic surgery is the perceived higher cost of Robotic lobectomy. To address these barriers, the investigators will undertake the first randomized controlled trial comparing Thoracoscopic Lobectomy to Robotic Lobectomy for early stage lung cancer.
Prospective randomization will eliminate the biases of retrospective data and will serve to determine whether there exist any advantages to Health Related Quality of life (HRQOL) or patient outcomes in favour of Robotic Lobectomy over VATS Lobectomy. Furthermore, through a prospective cost-utility analysis, this trial will provide the highest quality data to evaluate the true economic impact of robotic technology in thoracic surgery in a Canadian health system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thoracoscopic Lobectomy | Active comparator | Procedure: Video-assisted thoracoscopic surgery |
| Robotic Lobectomy | Active comparator | Procedure: Robotic thoracic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >/= 18 years
- Clinical stage I, II or IIIa non-small cell lung cancer (NSCLC)
- Candidates for minimally invasive pulmonary lobectomy, as determined by the operating surgeon.
Key exclusion criteria (2 listed)
- Clinical stage IIIb or IV NSCLC
- Not a candidate for minimally invasive surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Video-assisted thoracoscopic surgerypatients randomized to this arm will receive video-assisted thoracic surgery (VATS) | Procedure or surgery | Thoracoscopic Lobectomy |
| Robotic thoracic surgerypatients randomized to this arm will receive robotic thoracic surgery (RTS) with the da Vinci Robot | Procedure or surgery | Robotic Lobectomy |
Primary outcome
Difference in HRQOL scores at week 12 between the treatment groups
Time frame: 12 weeks post-surgery
Difference in HRQOL scores between the treatment groups, as measured by the EQ-5D-5L questionnaire at week 12.
21 secondary outcomes
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Short-term clinical outcome differences
Time frame: 3 weeks post-surgery
Resource utilization
Time frame: 1 year post-surgery
Resource utilization
Time frame: 1 year post-surgery
Resource utilization
Time frame: 1 year post-surgery
Resource utilization
Time frame: 1 year post-surgery
Resource utilization
Time frame: 1 year post-surgery
Resource utilization
Time frame: 1 year post-surgery
Resource utilization
Time frame: 1 year post-surgery
Resource utilization
Time frame: 1 year post-surgery
Cost Effectiveness
Time frame: 5 years post-surgery
Difference in HRQOL scores between the treatment groups
Time frame: 3, 7 weeks post-surgery; 6 months post-surgery; 1, 1.5, 2, 3, 4, 5 years post-surgery
Difference in 5-year survival rate between the two groups
Time frame: 5 years post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Sep 2025.
- Background: PubMed 18831499Grogan EL, Jones DR. VATS lobectomy is better than open thoracotomy: what is the evidence for short-term outcomes? Thorac Surg Clin. 2008 Aug;18(3):249-58. doi: 10.1016/j.thorsurg.2008.04.007.
- BackgroundOnaitis MW, Petersen RP, Balderson SS, et al. Thoracoscopic Lobectomy Is a Safe and Versatile Procedure. Transactions of the Meeting of the American Surgical Association. 2006;124:86-91. doi:10.1097/01.sla.0000234892.79056.63.
- Background: PubMed 24780416Veronesi G. Robotic thoracic surgery: technical considerations and learning curve for pulmonary resection. Thorac Surg Clin. 2014 May;24(2):135-41, v. doi: 10.1016/j.thorsurg.2014.02.009.
- Background: PubMed 24793685Nasir BS, Bryant AS, Minnich DJ, Wei B, Cerfolio RJ. Performing robotic lobectomy and segmentectomy: cost, profitability, and outcomes. Ann Thorac Surg. 2014 Jul;98(1):203-8; discussion 208-9. doi: 10.1016/j.athoracsur.2014.02.051. Epub 2014 May 1.
- Background: PubMed 22104677Park BJ, Melfi F, Mussi A, Maisonneuve P, Spaggiari L, Da Silva RK, Veronesi G. Robotic lobectomy for non-small cell lung cancer (NSCLC): long-term oncologic results. J Thorac Cardiovasc Surg. 2012 Feb;143(2):383-9. doi: 10.1016/j.jtcvs.2011.10.055. Epub 2011 Nov 20.
- Background: PubMed 24780422Wei B, D'Amico TA. Thoracoscopic versus robotic approaches: advantages and disadvantages. Thorac Surg Clin. 2014 May;24(2):177-88, vi. doi: 10.1016/j.thorsurg.2014.02.001.
- Background: PubMed 22440364Louie BE, Farivar AS, Aye RW, Vallieres E. Early experience with robotic lung resection results in similar operative outcomes and morbidity when compared with matched video-assisted thoracoscopic surgery cases. Ann Thorac Surg. 2012 May;93(5):1598-604; discussion 1604-5. doi: 10.1016/j.athoracsur.2012.01.067. Epub 2012 Mar 20.
- Background: PubMed 24090577Kent M, Wang T, Whyte R, Curran T, Flores R, Gangadharan S. Open, video-assisted thoracic surgery, and robotic lobectomy: review of a national database. Ann Thorac Surg. 2014 Jan;97(1):236-42; discussion 242-4. doi: 10.1016/j.athoracsur.2013.07.117. Epub 2013 Oct 1.
- Background: PubMed 24810546Paul S, Jalbert J, Isaacs AJ, Altorki NK, Isom OW, Sedrakyan A. Comparative effectiveness of robotic-assisted vs thoracoscopic lobectomy. Chest. 2014 Dec;146(6):1505-1512. doi: 10.1378/chest.13-3032.
- BackgroundHanna, WC., Fahim, C., Patel, P., Shargall, Y., Waddell TK., Yasufuku, K. (2015). Robotic Pulmonary Resection for Lung Cancer: The First Canadian Series. Abstract Accepted for podium presentation at Canadian Association of Thoracic Surgeons (CATS) 18th Annual Meeting, September 17-20, Quebec, QC.
- Background: PubMed 23915591Merritt RE, Hoang CD, Shrager JB. Lymph node evaluation achieved by open lobectomy compared with thoracoscopic lobectomy for N0 lung cancer. Ann Thorac Surg. 2013 Oct;96(4):1171-1177. doi: 10.1016/j.athoracsur.2013.05.044. Epub 2013 Jul 31.
- Background: PubMed 21718849D'Amico TA, Niland J, Mamet R, Zornosa C, Dexter EU, Onaitis MW. Efficacy of mediastinal lymph node dissection during lobectomy for lung cancer by thoracoscopy and thoracotomy. Ann Thorac Surg. 2011 Jul;92(1):226-31; discussion 231-2. doi: 10.1016/j.athoracsur.2011.03.134.
- Individual participant dataSharing planned: No
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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.
Waël C Hanna, MDCM, MBA, FRCSC principal investigator
McMaster University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Video-assisted thoracoscopic surgery and Robotic thoracic surgery in people with Non-small Cell Lung Cancer and Thoracic Surgery, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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 3 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 12 Sep 2025. 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 Canada. 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?
This study is still under way. Results are not available in the source record yet.
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?
Difference in HRQOL scores at week 12 between the treatment groups (time frame: 12 weeks post-surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02617186, which also lists 21 linked publications.
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 12 Sep 2025.