Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.
PLEACE
1 other identifier
interventional
294
1 country
1
Brief Summary
Is thoracoscopic surgery better than traditional open surgery for lung cancer? Video assisted thoracoscopic surgery for lung cancer (VATS) is presumed to be less traumatic than traditional open surgery for lung cancer but this has never been documented in a randomized trial. Some surgeons hesitate to use VATS because it is technically more demanding, others question if the two methods are oncologically equal. Regardless, VATS has been implemented as a routine method for lung cancer surgery several places around the world including Odense University Hospital. The investigators have launched the first randomized controlled trial in the world comparing the two surgical methods to investigate any differences in length of hospitalization, postoperative pain, life quality within the first year, and health economics. The investigators include patients with stage I and II lung cancer, and randomize between VATS and open surgery in a design where both the patient and doctors doing general rounds in the ward are blinded until discharge because the dressing on the surgical wound is identical, regardless of the surgical method. The surgeon cannot influence clinical decisions including time to discharge, which is decided by other specialist surgeons. Pain evaluation is performed 6 times daily using the VAS-score, life quality is evaluated continuously during the first 12 months using EQ5D and EORTC QLQC-30 questionnaires, and the consumption of analgetics in both groups are monitored via the national prescription database. Parallel to this trial a similar clinical study, which is also the first of its kind in the world, has been launched for patients with lung cancers not eligible for VATS. They are randomized between the two traditional open surgical methods (anterolateral and posterolateral thoracotomy) - this is also blinded to both patient and doctors doing rounds until discharge from hospital, and endpoint are similar in the two studies. 206 patients have been randomized in the first substudy (VATS vs. open) and 88 in the second substudy (posterolateral vs. anterolateral).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2008
Longer than P75 for not_applicable
1 active site
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
September 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 14, 2011
CompletedFirst Posted
Study publicly available on registry
January 19, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 18, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 18, 2017
CompletedOctober 23, 2020
October 1, 2020
9.1 years
January 14, 2011
October 21, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Postoperative pain
Aim is to asses the development of acute and chronic pain after lobectomy.
12 months
Secondary Outcomes (2)
Quality of life
12 months
Economy
12 months
Study Arms (2)
PLEACE 1
ACTIVE COMPARATORAnterolateral vs. posterolateral thoracotomy
PLEACE 2
ACTIVE COMPARATORVideo assisted thoracic surgery (VATS) vs. anterolateral thoracotomy
Interventions
Standard muscle sparing posterolateral thoracotomy
Eligibility Criteria
You may qualify if:
- Eligible for surgery for lunge cancer.
- Elective surgery (surgery planed \> 2 days)
- Accepts randomization
- Age 18 or above.
You may not qualify if:
- Previous thoracic surgery
- Planned segment resection or pneumonectomy.
- Any type of chronic pain, requiring daily use of analgetics
- pregnant
- Breast feeding
- T3, T4 tumors or cerebral tumors.
- contraindications to NSAID
- Chemo- and/or radiotherapy in connection to present admission.
- Major surgery planned in connection to this admission.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Peter B Lichtlead
Study Sites (1)
Odense University Hospital
Odense, Southern Denmark, 5000, Denmark
Related Publications (2)
Bendixen M, Kronborg C, Jorgensen OD, Andersen C, Licht PB. Cost-utility analysis of minimally invasive surgery for lung cancer: a randomized controlled trial. Eur J Cardiothorac Surg. 2019 Oct 1;56(4):754-761. doi: 10.1093/ejcts/ezz064.
PMID: 30838382DERIVEDBendixen M, Jorgensen OD, Kronborg C, Andersen C, Licht PB. Postoperative pain and quality of life after lobectomy via video-assisted thoracoscopic surgery or anterolateral thoracotomy for early stage lung cancer: a randomised controlled trial. Lancet Oncol. 2016 Jun;17(6):836-844. doi: 10.1016/S1470-2045(16)00173-X. Epub 2016 May 6.
PMID: 27160473DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Peter B Licht, Professor
Dept. Cardithoracic and Vascular Surgery
- PRINCIPAL INVESTIGATOR
Morten Bendixen, MD
Dept. Cardiothoracic and Vascular Surgery
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor, MD, pHd.
Study Record Dates
First Submitted
January 14, 2011
First Posted
January 19, 2011
Study Start
September 1, 2008
Primary Completion
September 18, 2017
Study Completion
September 18, 2017
Last Updated
October 23, 2020
Record last verified: 2020-10