Article Text

Protocol
Efficacy of avoiding chest drains after video-assisted thoracoscopic surgery wedge resection: protocol for a randomised controlled trial
  1. Bo Laksáfoss Holbek1,
  2. Lin Huang1,
  3. Thomas Decker Christensen2,3,
  4. Morten Bendixen2,3,
  5. Henrik Jessen Hansen1,
  6. Henrik Kehlet4,
  7. Rene Horsleben Petersen1,5
  1. 1Department of Cardiothoracic Surgery, Copenhagen University Hospital Rigshospitalet, København, Denmark
  2. 2Department of Cardiothoracic and Vascular Surgery, Aarhus University Hospital, Aarhus, Denmark
  3. 3Department of Clinical Medicine, Aarhus University, Aarhus, Denmark
  4. 4Section for Surgical Pathophysiology, Copenhagen University Hospital Rigshospitalet, København, Denmark
  5. 5Institute for Clinical Medicine, Faculty of Health and Medical Sciences, Copenhagen University, København, Denmark
  1. Correspondence to Dr Bo Laksáfoss Holbek; bo.laksafoss.holbek{at}regionh.dk

Abstract

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.

  • Clinical Trial
  • Patient Reported Outcome Measures
  • pain management
  • Thoracic surgery
  • Randomized Controlled Trial
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Footnotes

  • Contributors This trial was initiated on behalf of HJH and principal investigator (PI) RHP. Co-PI, BLH, has designed the trial and authored and revised the protocol, and he is the corresponding author. LH, RHP, HK, TDC, MB and HJH have reviewed and revised the protocol.

  • Funding LH has received a PhD scholarship from China Scholarship Council (Grant no. 201908430204) and a post-doc grant from Region Hovedstaden through Rigshospitalets Research Council (Grant no. R163-A7357-B5343) and a research grant from The Heart Centre’s Research Council, Rigshospitalet (Grant no. 5798001020572). RHP received a research grant from the Novo Nordisk Foundation (Grant no. NNF22OC0079013).

  • Disclaimer No funding agency has seen or commented on this trial protocol, and no funding agency will be included in the data collection, storage, management, analysis, or interpretation of the data. None of the investigators benefit economically from this trial.

  • 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.

  • Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.

  • Provenance and peer review Not commissioned; externally peer reviewed.

  • Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.