Efficacy of avoiding chest drains after video-assisted thoracoscopic surgery wedge resection: protocol for a randomised controlled trial.

Introduction: The use of routine postoperative chest drains after video-assisted thoracoscopic surgery (VATS) of the lung is a practice based on tradition with the aim of draining fluid and air. However, new evidence suggests that chest drains can be avoided in selected cases. With this randomised controlled trial, we wish to establish the efficacy and safety of avoiding postoperative chest drains compared with routine postoperative chest drains.
Methods and Analysis: This is a two-centre randomised controlled trial without allocation concealment, but where randomisation occurs after the end of procedure leaving operative personnel blinded during surgery. The sample size is calculated to show a difference in pain measurements using the Numeric Rating Scale under different circumstances and at different time points to show superiority of the intervention. The trial is pragmatic by design to reflect the daily clinical scenario and with the aim of increasing the external validity of the results.
Ethics and Dissemination: Approval by the local ethics committees has been obtained for both sites. The study was registered with ClinicalTrials.gov (NCT05358158) prior to inclusion. The results of the trial will be disseminated by publication in an international journal and presentation at major international thoracic surgical meetings.
Article Summary: This is a randomised controlled trial estimating the effects of avoiding a chest drain after VATS wedge resection of the lung on pain, total morphine use, quality of life and complications.
Trial Registration Number: NCT05358158.
Competing Interests: Competing interests: BLH has received a speaker’s fee from Medela Healthcare. HJH has received a speaker’s fee from Medtronic and BD. TDC has been on the speaker bureaus for AstraZeneca, Boehringer-Ingelheim, Pfizer, Roche Diagnostics, Takeda, Merck Sharp & Dohme (MSD) and Bristol-Myers Squibb and has been in an Advisory Board for Bayer and Merck Sharp & Dohme (MSD). RHP has received a speaker’s fee from Medtronic, AMU, AstraZeneca, Medela and is an advisory board member for AstraZeneca, Roche, MSD, BMS. LH, MB and HK have no conflicts of interest to report. This is an investigator-initiated trial with no ties to private industries.
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