Parastomal hernia outcomes after sutured versus unsutured composite techniques for specimen-extraction-site loop ileostomy following laparoscopic low anterior resection: the UNSEAL randomized controlled trial.

BACKGROUND

Protective loop ileostomy created at the specimen-extraction site is a minimally invasive option after laparoscopic low anterior resection for rectal cancer. Whether different composite techniques influence parastomal hernia risk remains uncertain.

METHODS

This prospective, open-label, single-center randomized controlled trial enrolled patients undergoing laparoscopic low anterior resection for rectal cancer with protective specimen-extraction-site loop ileostomy. Patients were randomized intraoperatively to a sutured composite technique, consisting of fascial/peritoneal fixation without a supporting rod, or an unsutured composite technique, consisting of no fascial/peritoneal fixation, routine supporting rod placement, and creation of a smaller tailored fascial aperture. The primary outcome was parastomal hernia before ileostomy reversal, assessed by standardized clinical examination, routine pre-reversal computed tomography, and intraoperative assessment at reversal.

RESULTS

Of 233 randomized patients, 216 were analyzed per protocol, including 111 in the sutured group and 105 in the unsutured group. Parastomal hernia occurred in 13.5% (15/111) and 4.8% (5/105), respectively (risk ratio 0.35, 95% CI 0.13-0.94; risk difference -8.7%, 95% CI - 16.3 to - 1.2; P = 0.047). Stoma formation time was shorter in the unsutured group (median 24 vs 31 min; Hodges-Lehmann difference - 7.2 min, 95% CI -9.0 to -5.4; P <0.001). Time to first stoma output was earlier in the unsutured group (median 12 vs 15 h; Hodges-Lehmann difference - 3.0 h, 95% CI - 4.7 to - 1.8; P <0.001), although this difference was not associated with shorter hospital stay. Other stoma-related complications, reversal outcomes, and quality of life scores were similar between groups.

CONCLUSION

The unsutured composite technique was associated with lower parastomal hernia risk and shorter stoma formation time compared with the sutured composite technique, without apparent differences in other stoma-related or reversal outcomes. Because the intervention comprised multiple technical components, the independent effect of each component could not be determined.

TRIAL REGISTRATION: The trial was registered at ClinicalTrials.gov (NCT06344923).