Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.

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).

Conditions

• Nonsmall Cell Lung Cancer Cellular Diagnosis

Interventions

PROCEDURE

Anterolateral thoracotomy

Standard anterolateral thoracotomy

PROCEDURE

Posterolateral thoracotomy

Standard muscle sparing posterolateral thoracotomy

PROCEDURE

VATS

Standard video assisted thoracic surgery, no use of rib-spreader.

PROCEDURE

Anterolateral Thoracotomy

Standard anterolateral thoracotomy

Sponsors & Collaborators

• Peter B Licht

  lead OTHER

Principal Investigators

• Peter B Licht, Professor · Dept. Cardithoracic and Vascular Surgery

• Morten Bendixen, MD · Dept. Cardiothoracic and Vascular Surgery

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2008-09-30

Primary Completion

2017-09-18

Completion

2017-09-18

Countries

• Denmark

Study Locations