Device-assisted fascial closure of 10-mm or larger trocar sites in laparoscopic gastrointestinal surgery: a prospective non-randomized controlled study

To evaluate the technical reliability of device-assisted fascial closure at eligible non-extraction trocar sites 10 mm or larger. Peri-umbilical extraction-wound outcomes were assessed separately as secondary exploratory outcomes. This single-centre prospective non-randomized controlled study included 389 consecutive patients undergoing laparoscopic gastric or colorectal surgery. The primary comparison was device-assisted versus conventional direct-vision fascial closure at eligible non-extraction trocar sites 10 mm or larger (252 vs. 137 patients). A standardized peri-umbilical extraction-wound protocol was concurrently used in the intervention group but was treated as a separate co-intervention. The primary outcome was patient-level fascial-closure failure at an eligible trocar site. Trocar-site hernia was secondary; extraction-wound morbidity and patient-reported cosmetic satisfaction on postoperative day 30 were exploratory. The groups differed in tumour site, extraction-incision location, and incision length. Eligible-site closure failure occurred in 0/252 intervention patients and 4/137 controls (risk difference, -2.9 percentage points; 95% confidence interval, -7.3 to -0.6; P = 0.015). A separate 5-mm drain-tract event occurred in one intervention patient. Trocar-site hernia was uncommon (0 vs. 1 case; P = 0.352). Exploratory extraction-wound hernia and wound-morbidity outcomes did not differ significantly; patient-reported cosmetic satisfaction was higher in the intervention group in an unadjusted comparison (mean difference, 0.30 points; 95% confidence interval, 0.20–0.40; P < 0.001). Device-assisted closure was associated with fewer eligible-site technical failures. Non-randomized allocation, sparse events, and potential operator confounding preclude claims of device superiority or hernia prevention. Findings from the concurrent extraction-wound protocol were separate exploratory results and should not be attributed to the closure forceps.