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Gastrointestinal Tract Recovery in Patients Undergoing Bowel ResectionResults of a Randomized Trial of Alvimopan and Placebo With a Standardized Accelerated Postoperative Care Pathway
Kirk Ludwig, MD;
Warren E. Enker, MD;
Conor P. Delaney, MD, PhD;
Bruce G. Wolff, MD;
Wei Du, PhD;
John G. Fort, MD;
Maryann Cherubini, BS, MFT;
James Cucinotta, RRT, MPH;
Lee Techner, DPM
Arch Surg. 2008;143(11):1098-1105.
Objective To investigate the efficacy and safety of alvimopan, 12 mg, administered orally 30 to 90 minutes preoperatively and twice daily postoperatively in conjunction with a standardized accelerated postoperative care pathway for managing postoperative ileus after bowel resection.
Design, Setting, and Patients This multicenter, randomized, placebo-controlled, double-blind, phase 3 trial enrolled adult patients undergoing partial bowel resection with primary anastomosis by laparotomy and scheduled to receive intravenous, opioid-based, patient-controlled analgesia. A standardized accelerated postoperative care pathway including early ambulation, oral feeding, and postoperative nasogastric tube removal was used to facilitate gastrointestinal (GI) tract recovery in all of the patients.
Main Outcome Measures The primary end point was time to GI-2 recovery (toleration of solid food and first bowel movement). Secondary end points included time to GI-3 recovery (toleration of solid food and first flatus or bowel movement), hospital discharge order written, and actual hospital discharge. Postoperative length of hospital stay based on calendar day of hospital discharge order written, opioid consumption, and overall postoperative ileus–related morbidity were recorded.
Results Alvimopan, 12 mg, was well tolerated and significantly accelerated GI-2 recovery, GI-3 recovery, and actual hospital discharge compared with a standardized accelerated postoperative care pathway alone (hazard ratio = 1.5, 1.5, and 1.4, respectively; P < .001 for all). Time to hospital discharge order written as measured by hazard ratio (1.4) and by postoperative calendar days (mean for alvimopan, 5.2 days; mean for placebo, 6.2 days) was also accelerated. Opioid consumption was comparable between groups, and alvimopan was associated with reduced postoperative ileus–related morbidity compared with placebo.
Conclusions Alvimopan, 12 mg, administered 30 to 90 minutes before and twice daily after bowel resection is well tolerated, accelerates GI tract recovery, and reduces postoperative ileus–related morbidity without compromising opioid analgesia.
Trial Registration clinicaltrials.gov Identifier: NCT00205842
Author Affiliations: Section of Colorectal and Gastrointestinal Surgery, Duke University Medical Center, Durham, North Carolina (Dr Ludwig); Division of Colorectal Surgery, Beth Israel Medical Center, New York, New York (Dr Enker); Division of Colorectal Surgery, University Hospitals of Cleveland, Cleveland, Ohio (Dr Delaney); Division of Colon and Rectal Surgery, Mayo Clinic, Rochester, Minnesota (Dr Wolff); and Adolor Corp, Exton, Pennsylvania (Drs Du, Fort, and Techner, Ms Cherubini, and Mr Cucinotta). Dr Ludwig is now with the Department of Surgery, Medical College of Wisconsin, Milwaukee.
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