A multicenter randomized controlled trial evaluating the effect of the use of an anti-adhesion barrier for diverting ileostomy on the multidimensional workload in minimally invasive surgery for rectal cancer (YCOG 2005: The ADOBARRIER study).

AIM

The purpose of this study was to assess whether the use of spray-type anti-adhesion material during diverting ileostomy construction could reduce the surgeon's multidimensional workload, the degree of adhesion, and the operation time in ileostomy closure.

METHODS

Patients diagnosed with rectal cancer, who were scheduled for laparoscopic or robotic rectal surgery followed by diverting ileostomy, were single-blindly (patient-blind), randomly assigned to either the AdSpray™ arm or the control arm. The primary endpoint was the multidimensional workload of the ileostomy closure operator (SURG-TLX value).

RESULTS

Between January 2020 and December 2022, 126 patients were enrolled. Five patients were excluded and a total of 121 patients (control arm,  = 60; AdSpray™ arm,  = 61) were analyzed. The baseline factors were well balanced between the two arms. Regarding SURG-TLX in ileostomy closure, operators in the AdSpray™ arm required a significantly lower overall workload than those in the control arm (AdSpray™ arm, 28.1; control arm, 58.9;  < 0.001). Mental, physical, and temporal demands, task complexity, situation stress, and distractions were significantly lower in the AdSpray™ arm ( < 0.001). Operative time was significantly shorter in the AdSpray™ arm (AdSpray™ arm, 58 min; control arm, 65 min;  = 0.040). The degree of adhesion ( < 0.001) and extent of intra-abdominal adhesions ( < 0.001) in ileostomy closure were significantly lower in the AdSpray™ arm.

CONCLUSIONS

The use of spray-type anti-adhesion material was associated with a significantly lower SURG-TLX value, lower incidence of adhesion, less severe adhesion, and shorter operative time.