Remote ischemic preconditioning for reduction of ischemia-reperfusion injury after hepatectomy: A randomized sham-controlled trial.

BACKGROUND: Remote ischemic preconditioning reduces ischemia-reperfusion injury in patients undergoing hepatectomy. Moreover, there is evidence that the protective effects of remote ischemic preconditioning may be more pronounced in pre-damaged livers. The objective of this trial was to investigate the extent to which remote ischemic preconditioning can attenuate ischemia-reperfusion injury after hepatectomy and Pringle maneuver in patients with chronic liver disease. METHODS: In this randomized, controlled, triple-blind monocenter trial, a total of 102 patients with chronic liver disease and planned hepatectomy were enrolled between December 2019 and March 2022. Eligible patients were randomized to the remote ischemic preconditioning or sham arms. Remote ischemic preconditioning was induced through 3 10-minute cycles of alternating ischemia and reperfusion of the upper extremity. The study was prospectively registered in the German Clinical Trials Registry (DRKS00018931). RESULTS: A total of 102 patients were included in the study and were randomized (51 per arm). The median age was 69.5 years, approximately two-thirds of the patients were male (69/102, 67.7%), and the mean body mass index was 25.6 kg/m2. Most patients were classified as American Society of Anesthesiologists II (55/102, 53.9%) or III (45/102, 44.1%). The primary endpoint, the transaminases on the first postoperative day (alanine aminotransferase /aspartate aminotransferase: remote ischemic preconditioning arm: 250 (35-1721)/320 (42-1525) U/L versus sham control arm: 283 (32-792)/356 (20-1851) U/L, P = .820/0.639), clinical outcomes as well as remote ischemic preconditioning biomarker levels were comparable between both arms. CONCLUSION: Remote ischemic preconditioning did not achieve a significant reduction in postoperative transaminase levels, nor did it affect clinical results and biomarkers.

Surgical trials and trial registers: a cross-sectional study of randomized controlled trials published in journals requiring trial registration in the author instructions.

BACKGROUND: Trial registration and the reporting of trial results are essential to increase transparency in clinical research. Although both have been strongly promoted in recent years, it remains unclear whether they have been successfully implemented in surgery and surgery-related disciplines. In this cross-sectional study, we assessed whether randomized controlled trials (RCTs) published in surgery journals requiring trial registration in their author instructions were indeed registered, and whether the study results of registered RCTs had been submitted to the trial register and were thus publicly available. METHODS: The ten highest ranked surgery journals requiring trial registration by impact factor (Journal Citation Reports, JCR, 2011) were chosen. We then searched MEDLINE (in PubMed) for RCTs published in the selected journals between 1 June 2012 and 31 December 2012. Any trials recruiting participants before 2004 were excluded because the International Committee of Medical Journal Editors (ICMJE) first proposed trial registration in 2004. We then searched the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) to assess whether the identified RCTs were indeed registered and whether the results of the registered RCTs were available in the register. RESULTS: The search retrieved 588 citations. Four hundred and sixty references were excluded in the first screening. A further 25 were excluded after full-text screening. A total of 103 RCTs were finally included. Eighty-five of these RCTs (83%) could be found via the ICTRP. For 7 of 59 (12%) RCTs, which were registered on ClinicalTrials.gov, summary study data had been posted in the results database. CONCLUSIONS: Although still not fully implemented, trial registration in surgery has gained momentum. In general, however, the submission of summary study data to ClinicalTrials.gov remains poor.