Reply to C. Zhuang et al.

Abstract

We thank Zhuang et al for their interest in the EnROL (Enhanced Recovery Open Versus Laparoscopic) trial and appreciate the opportunity to clarify the points that they raised. Zhuang et al were concerned that compliance with early oral feeding, early mobilization, and optimized analgesia was low in the enhanced recovery program (ERP) in the trial. They suggested that low compliance with specific aspects of an ERP means that the trial is underpowered and that more work is still needed. Although it is important to consider which aspects of an ERP are most critical to patient recovery, the concerns of Zhuang et al are not well founded because EnROL aimed to compare laparoscopy with open surgery, and the application of and compliance within the ERP was similar in both groups of the trial; therefore, the treatment effect that was reported is likely to be robust. To date, there have been limited data reported on compliance with enhanced recovery interventions within randomized controlled trials (RCTs). The results of the EnROL trial are similar to those reported for the LAFA (Laparoscopy and/or Fast Track) trial, which is the only other similar, multicenter RCT. Maximum differences would be postulated to be seen within a single-center study, but the advantage of multicenter research is that it reflects clinical effectiveness and thus is more representative of practice generally. More than 30 items were included in the EnROL trial, although compliance measurement was limited to the 20 items that were recommended by the international expert collaborative advisory group on enhanced recovery care (Enhanced Recovery After Surgery Society [ERAS]) to make data collection manageable. This is, to our knowledge, more than has ever previously been reported. Although the administration of antiemetics was not measured, their use has been standard practice within the United Kingdom for many years. EnROL was a pragmatic trial and allowed a certain amount of variability between centers, as one would expect in real-world practice. As a result, the trial aimed to maximize the generalizability and translation of results while maintaining scientific rigor and integrity. Some researchers might concur with Zhuang et al that more well-designed and conducted RCTs are important to validate these findings and increase evidence-based practice in surgery worldwide. Others might take the view that recruitment for a similar trial is becoming increasingly difficult as patients become better informed, and surgeons would be better occupied in gaining competence in laparoscopic colorectal surgery so that their patients might benefit from its advantages.