Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economy. (PLEACE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Information provided by (Responsible Party):
Peter B Licht, Odense University Hospital

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 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: PLEACE 1
Anterolateral vs. posterolateral thoracotomy
Procedure: Anterolateral thoracotomy
Standard anterolateral thoracotomy
Other Name: ALT
Procedure: Posterolateral thoracotomy
Standard muscle sparing posterolateral thoracotomy
Other Name: PLT
Active Comparator: PLEACE 2
Video assisted thoracic surgery (VATS) vs. anterolateral thoracotomy
Procedure: VATS
Standard video assisted thoracic surgery, no use of rib-spreader.
Procedure: Anterolateral Thoracotomy
Standard anterolateral thoracotomy
Other Name: ALT

Primary Outcome Measures :
  1. Postoperative pain [ Time Frame: 12 months ]
    Aim is to asses the development of acute and chronic pain after lobectomy.

Secondary Outcome Measures :
  1. Quality of life [ Time Frame: 12 months ]
    Three questionnaires are used. EQ5D, QLQC-30 and WPAI.

  2. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Eligible for surgery for lunge cancer.
  • Elective surgery (surgery planed > 2 days)
  • Accepts randomization
  • Age 18 or above.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01278888

Contact: Morten Bendixen, MD + 45 65 41 24 25
Contact: Peter B Licht, Professor + 45 65 41 24 25

Odense University Hospital Recruiting
Odense, Southern Denmark, Denmark, 5000
Contact: Susanne Petersen, Nurse    + 45 65 41 24 25   
Principal Investigator: Morten Bendixen, MD         
Sponsors and Collaborators
Peter B Licht
Study Director: Peter B Licht, Professor Dept. Cardithoracic and Vascular Surgery
Principal Investigator: Morten Bendixen, MD Dept. Cardiothoracic and Vascular Surgery

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Peter B Licht, Professor, MD, pHd., Odense University Hospital Identifier: NCT01278888     History of Changes
Other Study ID Numbers: s-20080085
First Posted: January 19, 2011    Key Record Dates
Last Update Posted: January 3, 2014
Last Verified: January 2014

Keywords provided by Peter B Licht, Odense University Hospital:
Lung cancer
Quality of life

Additional relevant MeSH terms:
Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms