Safety assessment of dextrin hydrogel adhesion barrier (AdSpray®) for elective laparoscopic cholecystectomy

Abstract

Objective

Adhesion barriers have not traditionally been used during laparoscopic cholecystectomy (lap-chole), and so there are no data confirming the safety of the dextrin hydrogel adhesion barrier (AdSpray®) for the use during lap-chole. The aim of this prospective study is to investigate the safety of AdSpray® for elective lap-chole.

Methods

Between July 2019 and March 2021, we conducted a prospective study at Saiseikai Kumamoto Hospital to assess the safety of applying AdSpray® around the hepatoduodenal ligament, liver surface, and port area after extraction of the gallbladder during elective lap-chole. We assessed patient morbidity, mortality, and laboratory data on postoperative day 1 and at the outpatient follow-up visit.

Results

A total of 100 patients (43 men, 57 women) received AdSpray® application during elective lap-chole at our institution. The mean patient age was 56.5 ± 14.8 y, and the mean body mass index was 25.1 ± 4.8 kg/m². Preoperative gallbladder drainage was performed in 3 (3.0%) patients as conservative treatment for acute cholecystitis. The mean operative time was 91.7 ± 35.1 min, and the median blood loss was 5 mL (range, 5–120 mL). Intraoperative gallbladder perforation was observed in 4.0% of patients (n = 4). There was no intraoperative bile duct injury. One (1.0%) patient had a postoperative subhepatic fluid collection without bacterial infection. The mean white blood cell count and C-reactive protein level was significantly elevated on postoperative day 1 but returned to preoperative levels by the time of the follow-up visit. All patients were successfully discharged after surgery, and the median postoperative hospital stay was 2 d (range, 2–9 d).

Conclusion

Applying AdSpray® during elective lap-chole is safe, with an acceptable rate of postoperative complications.