Statistics
toxicity, blood loss
PRIMARY TUMOR, PERITONEAL CARCINOMATOSIS, BLOOD LOSS, DISEASE
A balanced two-stage clinical trial design was utilized with a primary endpoint of 30-day morbidity following minimally invasive CRS/HIPEC. The rate of 30-day morbidity following open HIPEC was approximately 43% (null hypothesis). A clinically meaningful reduction in postoperative morbidity was determined to be 23%, bringing 30-day morbidity down to 15% (alternate hypothesis). A sample size of 18 patients accrued in two stages to yield a power of 81% to detect a 28% decrease in the rate of toxicity (from 43 to 15%) assuming Variables collected included: Age, body mass index (BMI), gender, primary tumor site, histologic diagnosis, peritoneal carcinomatosis index (PCI), operative time, estimated blood loss (EBL), number of organs resected, number of anastomoses, completeness of cytoreduction (CC) score, time to first flatus, length of intensive care unit (ICU) stay, length of hospital stay, 30-day morbidity, 30-day mortality, disease free survival (DFS), and overall survival (OS). Descriptive statistics were utilized to assess categorical and continuous variables. Mean and median DFS and OS were determined with the Kaplan–Meier test.