Clinical Impact of Using 4% Icodextrin as an Adhesion Prophylactic Agent in High-Risk Gynecological Laparoscopic...

Background/Objectives: The objective of this study was to evaluate, for the first time, the effectiveness and safety of 4% icodextrin solution by detecting the incidence of adhesion-related morbidities (adhesion-related hospital readmissions, including reoperations) when used as an adhesion prophylactic agent during laparoscopic gynecologic surgery. Methods: The study was a single-arm, two-center, retrospective study. The incidence of hospital readmissions that were directly or possibly related to adhesions following the use of 4% icodextrin in laparoscopic gynecologic surgery, 2 years from the date of index surgery, was assessed either via chart review alone or, when found necessary, in combination with patient-completed questionnaires. Patient safety was evaluated through reported adverse events. The relationship between clinical events and the use of 4% icodextrin was assessed by investigators based on patient-level data. Results: After 149 patients were screened, the study finally included 123 patients; 4 (3.3%; 95% CI: 0.89%, 8.12%) had at least one reoperation or readmission that was directly or possibly related to adhesion within 2 years of index surgery. In the supplemental analysis (67 patients using chart and questionnaire data), this incidence rate was 10.4% (95% CI: 4.30%, 20.35%). No adverse events related to the use of 4% icodextrin were reported. Conclusions: This is the first study ever evaluating hospital readmission/reoperation rates after application of a specific adhesion prophylactic agent. The results indicate that 4% icodextrin is safe and effective when used as an intraperitoneal instillate for reduction in adhesions in gynecological laparoscopic procedures. It has a lower readmission and reoperation rate compared to meta-analysis data in the international literature.