Short summary

The issue of acute pain after thoracotomy has long been a controversial subject that has led to many reflections on surgical technique and postoperative pain treatment. The vast majority of published randomized studies are dealing with pain treatment, while reflections on the surgical technique are more based on a theoretical basis.

Rationale

In Denmark, around 1300 Thoracotomies are performed every year and there are different surgical accesses. In Odense the most frequently access is used, the Posterolateal, for open surgery, but in recent times the Video-assisted Thoracic Surgery (VATS) access has been used, when possible. At Skejby Hospital it is routine to use the Anterolateral Standard Thoracotomy access. The difference lies in the tradition and local culture, as there are no randomized studies within the area.

The aim of this study is to examine whether there is a difference in the existens of acute and chronical post-surgery pain and lifequality for the patients who undergoes surgery for Lungcancer with three different technics and also aims to evaluate the health economic perspective. The cohorte also allows us to examine surgical stress, tumor markers and survival.

Description of the cohort

The cohort includes consecutive patients whom are submitted for surgery for Lungcancer at Odense University Hospital. The study consists of two sub-cohorts: Group 1 (n=206) is randomized between VATS (Video-assisted Thoracic Surgery) and Anterolateral Standard  Thoracotomy. Group 2  (n=88) is randomized between Posterolateal and Anterolateral Standard Thoracotomy. The study is blinded for patients, nursing staff and the doctors who do the ward rounds.

Patients are asked to grade their pain according to a NRS-score (Numeric Rating Scale) six times a day. By doing this we are able to get a very precise picture of the pain pattern. The score is registrated both when resting and in activity/choughing. The registration will take place on all the post-surgical days while the patient is still at the hospital. There will be a baseline registration pre-surgical at the submittion interview. After discharge from the hospital the patients will be VAS-scored at 15 days, 1, 2, 3, 6 and 12 month. Futhermore ½ cm³ malignant tissue and ½ cm³ healthy tissue will be taken at the resection. At the same time intervals all patients will fill out two quality of life (QoL) questionnaires (EORTC-QLQ-C30 and EQ5D).

The third sub-study keeps record of the patients use of analgesic over a period of 12 month, information is gathered from Danish Registry for Medical Product Statistics.

Data and biological material

VAS-score results, QoL-results, and tissue samples. Data from The National Health Insurance Register, The National Patient Register, The National Prescription Registry etc. via OPEN's authorization to Statistics Denmark.

Collaborating researchers and departments

Department of Cardiothoracic and Vascular surgery, Aarhus University Hospital

• Staff-specialist and Cardiothoracic surgeon Morten Bendixen, PhD

Department of Thoracic and Cardiovascular Surgery, Odense University Hospital

• Consultant Cardiologist Ole Dan Jørgensen, PhD

Department of Anaesthesiology and Intensive Care, Thorax Anaesthesiology Unit VITA, Odense University Hospital

• Consultant Anesthesiologist Claus Andersen, PhD

Institute of Public Health, University of Southern Denmark

• Associate Professor Christian Kronborg, Msc econ, PhD

Publications associated with the project

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; Bendixen M, Jørgensen OD, Kronborg C, Andersen C, Licht PB. Lancet Oncol. 2016 Jun;17(6):836-44. 

Quality of life after video-assisted surgery for lung cancer - Author's reply; Licht PB, Andersen C, Dan Jørgensen O, Bendixen M. Lancet Oncol. 2016 Aug;17(8):e318-9.