Robotic natural orifice specimen extraction surgery for colorectal cancer: an open-label, single-arm study

Abstract

Background: Robotic natural orifice specimen extraction surgery (NOSES) is a minimally invasive surgery for colorectal cancer patients. As an emerging procedure, its safety and feasibility require thorough investigation. This study aimed to evaluate preliminary data and provide evidence for the therapeutic benefits and clinical applicability of robotic NOSES in colorectal cancer patients.Methods: This was an open-label single-arm study that recruited patients with colorectal cancer and treated them with robotic NOSES, which was performed by three methods of specimen extraction: a: transanal specimen eversion and extra-abdominal resection technique (EVER); b: translumenal specimen extraction and extra-abdominal resection technique (EXER); c: intra-abdominal specimen resection and translumenal extraction technique (IREX). The primary outcome was the complication rate. Between September 1, 2019, and May 31, 2020, 118 individuals were screened, and 101 were included in the intention-to-treat population. Lastly, after further evaluation, 91 individuals were included in the per-protocol population. Safety analyses were performed using SPSS 22.0 (SPSS, Chicago, USA). P-value < 0.05 was considered statistically significant.Results: A total of 118 patients were screened, and 101 were enrolled for the robotic NOSES. Ten patients switched to traditional robotic-assisted surgery. Hypertension [13 (14.29%)] was the most common comorbidity. The overall complication rate was 18.68%, and the most common complication was anastomotic fistula (B and C level) [8 (8.79%)]. There was no significant difference in complication rate among the three methods of specimen extraction in the subgroup analysis (P = 0.638).Conclusion: Robotic NOSES can provide feasibility for colorectal cancer patients to a certain extent. The most prevalent surgical complication of robotic NOSES for colorectal cancer patients was anastomotic fistula (B and C level) [8 (8.79%)].