Comment on “Effects of Community-based Exercise Prehabilitation for Patients Scheduled for Colorectal Surgery With High Risk for Postoperative Complications: Results of a Randomized Clinical Trial”

Abstract

endpoint. Was this performed in an attempt to demonstrate superiority, noninferiority or equivalence between the 2 arms? Given lack of a homogenous control (surgeon preference) group, what parameters (from previously published data) informed the sample size calculation? 3. MRI has a significant impact on the diagnosis and management of these patients. 2 The eligibility criteria and the need to have an MRI 6 months before randomization are clearly described. Thirteen of patients in the fistula plug arm and 10% in the surgeon preference arm did not have a trans-sphincteric fistula at MRI. MRI results, however, did not appear to affect inclusion in the trial. Was consideration given to exclude patients where the condition was excluded on MRI, as this would be a reasonable reason for post randomization exclusion? 3 4. The authors highlight in their limitation the fact that blinding was not attempted in this trial. They also highlight how this is unlikely to have affected the primary outcome. The chosen primary outcome is, however ''patient reported" and susceptible to bias in an open trial. Nonblinding of patients in the context of patient reported outcomes has been shown to introduce significant bias. 4 Was consideration given to choose an objective primary outcome? 5. The level of experience of the surgeon performing the EUA has been shown to affect sensitivity of such procedures. 5 Are data on experience of the surgeons performing the original diagnostic EUA for the patients included in the study? 6. The author specified how minimization was performed for the preoperatively (pre randomization) planned procedure. It is quite common, however, for the surgeon performing the procedure to change their approach based on EUA findings. Are data on this available and could this have affected outcomes? Overall, the results of this trial indicate that surgisis plug is unlikely to significantly improve outcomes of trans-sphincteric fistula repair in settings where a variety of different treatments are used, but the lack of specific pairwise comparisons preclude conclusions about the superiority of the plug over individual treatments.

Response to the Comments of Onerup et al and Lu and Song on: “Effects of Community-based Exercise Prehabilitation for Patients Scheduled for Colorectal Surgery With High Risk for Postoperative Complications: Results of a Randomized Clinical Trial”

“…Our study was specifically and exclusively powered to detect a statistically significant difference in the number of patients with 1 or more postoperative complications between the prehabilitation group and usual care group 3. We agree with Onerup et al1 that especially the prevention of severe complications would be of great relevance to the patients, caregivers, the need of health care resources, and, consequently, costs. However, costs associated with the prevention of (the impact of) complications would probably outweigh the costs of the care for the postoperative complications, and preventing complications (also minor complications) would considerably reduce the patient’s physical, mental, and social burden.…”

“…We read with interest the recently published comments of Onerup et al1 and Lu and Song2 on our randomized controlled trial 3. We thank the authors for their valuable comments.…”

“…As Onerup et al1 and Lu and Song2 properly declare, there is a small, nonsignificant, difference in the number of smoking patients in the prehabilitation group (n=1, 4%) and usual care group (n=6, 21%, P =0.112) and in the number of patients with an age-adjusted Charlson Comorbidity Index of 6+ in the prehabilitation group (n=4, 14%) and usual care group (n=7, 24%, P =0.416). Smoking was not associated with postoperative complications, as there were 3 smoking patients without complications and 4 smoking patients with complications ( P =1.00).…”

“…Onerup et al1 stated that our supervised community-based physical exercise intervention could only be performed by <5% of the total population with colorectal cancer screened and assessed during our study period, which limits the generalizability of the results. We think this statement is not correct, since we specifically aimed at identifying and including patients at high risk for postoperative complications, based on a predefined CPET criterion, and to evaluate the effectiveness of an exercise prehabilitation program in this specific group, and not in the total population of patients with colorectal cancer.…”

“…One of our inclusion criteria was the willingness to perform community-based prehabilitation at a physical therapy practice in the catchment area of both hospitals. Onerup et al1 stated that this information should have led to several participants suspecting the nature of the intervention and included a selection of study participants. However, since we informed patients in the prehabilitation group and the usual care group differently, patients in the usual care group did not receive information about the possible effects of prehabilitation.…”