Clinical trial · Interventional
Minimally Invasive or Open Surgery for Lung Cancer: Pain, Quality of Life and Economics.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nonsmall Cell Lung Cancer Cellular Diagnosis | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Anterolateral thoracotomy | Procedure | — | UNRESOLVED |
| Posterolateral thoracotomy | Procedure | — | UNRESOLVED |
| VATS | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- PLEACE 1
- description
- Anterolateral vs. posterolateral thoracotomy
- interventionNames
- Procedure: Anterolateral thoracotomy
- Procedure: Posterolateral thoracotomy
- type
- ACTIVE_COMPARATOR
- label
- PLEACE 2
- description
- Video assisted thoracic surgery (VATS) vs. anterolateral thoracotomy
- interventionNames
- Procedure: VATS
- Procedure: Anterolateral Thoracotomy
Primary outcomes (1)
- measure
- Postoperative pain
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- DERIVEDBendixen 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 30838382
- DERIVEDBendixen 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 27160473