Assessing reinforced tension line sutures for hernia prevention: methodological considerations from the Rein4CeTo1 trial

Correspondence to: Anshika Upasani (email: anshikaupasani11@gmail.com)

Department of General Surgery

All India Institute of Medical Sciences

Patna

India

BJS Open, https://doi.org/10.1093/bjsopen/zrae053, published 13 July 2024

We read with interest the article by Nilsson et al.1 The authors are praised for their meticulously executed randomized trial assessing the efficacy of reinforced tension-line (RTL) sutures in diminishing incisional hernia rates post-colorectal cancer surgery.

The study's strengths encompass a rigorous methodology, notably the randomization process, blinding of CT interpreters, and emphasis on the primary outcome of CT-diagnosed incisional hernia at the 1-year follow-up. The results indicate a decrease in hernia rates in the RTL group (6%) relative to the polydioxanone (PDS) group (21%), which is encouraging. Furthermore, the utilization of CT imaging enhances value owing to its superior sensitivity relative to clinical examination. The incorporation of fascial closure times, fragility index, and number needed to treat further augments the study's significance and applicability.

Nonetheless, numerous issues require consideration. The utilization of distinct suture materials—polypropylene in the RTL group and polydioxanone in the PDS group—may obscure the results2. Polypropylene is a non-absorbable suture providing permanent reinforcement, whereas polydioxanone is absorbable. The authors must elucidate how this disparity may have impacted the recorded variations in hernia rates.

A statistically significant difference in the application of neoadjuvant radiotherapy between the groups (P = 0.030) necessitates further examination. The authors propose that this discrepancy is unlikely to influence the results; however, the effects of radiotherapy on wound healing and hernia development warrant further investigation, as radiotherapy has deleterious effects on both immediate and long-term wound healing3. Modifying for this variable could enhance the results. The study also highlights a higher rate of stoma creation in the RTL group (P = 0.020). While this is mentioned, the authors do not explore the potential causes. Given the clinical significance of stoma creation, a deeper investigation into whether this outcome is linked to the RTL technique or other factors is necessary.

Ultimately, the study was underpowered, attaining merely 75.1% of the intended 80% power. Although the primary endpoint retains statistical significance, the diminished power constrains the confidence in these findings. More extensive studies with adequate power would yield more dependable conclusions and possibly validate the function of RTL sutures in decreasing hernia rates. In conclusion, although the study by Nilsson et al. provides significant preliminary evidence, it is imperative that future research addresses the aforementioned concerns to validate the RTL suture's efficacy in clinical practice.