Patterns of Gastrointestinal Recovery after Bowel Resection and Total Abdominal Hysterectomy: Pooled Results from the Placebo Arms of Alvimopan Phase III North American Clinical Trials

Abstract

Postoperative ileus (POI), a transient cessation of coordinated bowel motility, occurs to some extent after all major abdominal operations. This analysis examines gastrointestinal (GI) recovery and hospital discharge history in patients undergoing partial bowel resection (BR) or total abdominal hysterectomy (TAH) by laparotomy in the placebo arms of recent phase III alvimopan trials. This was a pooled post hoc analysis of placebo groups from randomized, double-blind, parallel-group, multicenter trials. All patients were uniformly managed with a standardized accelerated postoperative care pathway to facilitate GI recovery. Of the 727 BR patients and 140 TAH patients included in this analysis, POI as an adverse event was reported in approximately 14.7% of BR patients and 2.9% of TAH patients, and postoperative nasogastric tube insertion was required in 11.5% of BR patients and 0.8% of TAH patients. Time to first toleration of solid food was almost 2 days longer for BR patients than for TAH patients (BR, 4.1 days; TAH, 2.5 days). Approximately 34.4% of BR patients and 4.2% of TAH patients had discharge orders written 7 days or more after operation. Nearly half (40%) of patients undergoing TAH were discharged from the hospital before GI recovery was complete. Mean postoperative lengths of hospital stay after BR and TAH were 6.6 days and 3.4 days, respectively. Despite the relatively fast recovery observed with standardized accelerated postoperative care pathway use, POI as an adverse event was still reported in approximately 15% of BR patients and 3% of TAH patients. This analysis provides important clinical insight into the differences in GI recovery patterns and the incidence and impact of POI after BR and TAH.