drugset / Trial / NCT05645198

The Effect of Carboxymetyl Starch (Oozfix) on Preventing Postoperative Complication After Gastrectomy

NCT05645198 ↗

Phase 4 Unknown 180 enrolled Bucheon St. Mary's Hospital
RandomizedParallel-groupOpen-labelPrevention

Summary

Although the technique of radical gastrectomy had been advanced, postoperative complication can occur in 13\~25% of patient after radical gastrectomy. Pancreatic fistula and postoperative bleeding was reported as 2\~30% and 1\~2%, respectively. These complications often result fatal clinical course, so localized fibrin agent has been widely used at postoperative surgical bed after radical gastrectomy. Recently, natural origin polysaccharide-based carboxymetyl starch was approved as localized coagulative, no well-designed report was adressed in gastric cancer surgery field. This agent can formate physical barrier after application, thus can prevent microbleeding or pancreatic fistula after gastrectomy. THIS study is single-center, non-inferiority, open-label randomized trial that evaluates the effect of carboxymetyl starch (Oozfix) on preventing postoperative complication after gastrectomy.

Timeline

Start
2022-10-26
Primary completion
2024-12-31
Completion
2025-01-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Greenplast Unknown 4 g Topical
Subject carboxymetyl starch Other / unclassified 5 g Topical

Indications