Inflammatory response and short-term outcomes after laparoscopic versus robotic transabdominal preperitoneal inguinal hernia repair: Randomized clinical trial (ROLAIS)

Background: The aim of this study was to compare robotic-assisted transabdominal preperitoneal (R-TAPP) and conventional laparoscopic transabdominal preperitoneal (L-TAPP) inguinal hernia repair with respect to surgical stress response and short-term outcomes. Methods: This single-centre, open-label, RCT enrolled patients undergoing elective inguinal hernia repair. Patients were randomized 1: 1 to R-TAPP or L-TAPP using a computer-generated sequence with block sizes of six. All procedures were performed by the same experienced surgeons. The primary outcome was plasma C-reactive protein (CRP) levels. Secondary outcomes included interleukin 6 (IL-6) levels, operating time, complications, length of stay, and readmission rate. Results: A total of 150 patients (R-TAPP, 76; and L-TAPP, 74) were randomized, with 11 withdrawing before surgery, leaving 139 (R-TAPP, 74; and L-TAPP, 65) for intention-to-treat analysis. CRP levels were significantly lower after R-TAPP on postoperative days 1 and 3 (reductions of 23% and 32% respectively, P = 0.001). IL-6 levels were also lower after R-TAPP at 30 and 120 min after extubation (reductions of 26% and 22% respectively, P < 0.001). R-TAPP was associated with a shorter operating time (-13.4 min, P < 0.001), fewer complications (23.0% versus 41.5%, P = 0.029), including fewer haematomas (6.8% versus 18.5%, P = 0.043), and a higher same-day discharge rate (95.9% versus 81.5%, P = 0.012). No significant differences were observed regarding chronic pain and recurrence rates. Conclusion: R-TAPP was associated with reduced surgical stress, complications, operating time, and hospitalization compared with L-TAPP. These findings support further multicentre trials to assess long-term outcomes and generalizability. Registration number: NCT05839587 (http://www.clinicaltrials.gov).