Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economy. (PLEACE)
|ClinicalTrials.gov Identifier: NCT01278888|
Recruitment Status : Unknown
Verified January 2014 by Peter B Licht, Odense University Hospital.
Recruitment status was: Recruiting
First Posted : January 19, 2011
Last Update Posted : January 3, 2014
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 economical aspects.
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.
250 patients will be asked to participate in each study - so far, 91 patients has been randomized and patient accrual is beginning soon at Skejby University Hospital,Denmark in collaboration with surgeons from department of thoracic surgery.
|Condition or disease||Intervention/treatment||Phase|
|Nonsmall Cell Lung Cancer Cellular Diagnosis||Procedure: Anterolateral thoracotomy Procedure: Posterolateral thoracotomy Procedure: VATS Procedure: Anterolateral Thoracotomy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Care Provider)|
|Official Title:||Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economy.|
|Study Start Date :||September 2008|
|Estimated Primary Completion Date :||August 2014|
|Estimated Study Completion Date :||August 2014|
Active Comparator: PLEACE 1
Anterolateral vs. posterolateral thoracotomy
Procedure: Anterolateral thoracotomy
Standard anterolateral thoracotomy
Other Name: ALTProcedure: Posterolateral thoracotomy
Standard muscle sparing posterolateral thoracotomy
Other Name: PLT
Active Comparator: PLEACE 2
Video assisted thoracic surgery (VATS) vs. anterolateral thoracotomy
Standard video assisted thoracic surgery, no use of rib-spreader.Procedure: Anterolateral Thoracotomy
Standard anterolateral thoracotomy
Other Name: ALT
- Postoperative pain [ Time Frame: 12 months ]Aim is to asses the development of acute and chronic pain after lobectomy.
- Quality of life [ Time Frame: 12 months ]Three questionnaires are used. EQ5D, QLQC-30 and WPAI.
- Economy [ Time Frame: 12 months ]An economical evaluation will be done. Including in-hospital expences, use of sociale-security, readmissions to hospital, use of family practioner, use of and duration of prescription analgetics, wether or not patients are able to return to work, the effect this type of surgery has on the patients quality of life, including a QALY evaluation and cost utility analysis.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01278888
|Contact: Morten Bendixen, MD||+ 45 65 41 24 email@example.com|
|Contact: Peter B Licht, Professor||+ 45 65 41 24 firstname.lastname@example.org|
|Odense University Hospital||Recruiting|
|Odense, Southern Denmark, Denmark, 5000|
|Contact: Susanne Petersen, Nurse + 45 65 41 24 25 email@example.com|
|Principal Investigator: Morten Bendixen, MD|
|Study Director:||Peter B Licht, Professor||Dept. Cardithoracic and Vascular Surgery|
|Principal Investigator:||Morten Bendixen, MD||Dept. Cardiothoracic and Vascular Surgery|