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Robot-Assisted Radical Antegrade Modular Pancreatosplenectomy Including Resection and Reconstruction of the Spleno-Mesenteric Junction
Published on: January 3, 2020
Alvimopan accelerates gastrointestinal recovery after radical cystectomy: a multicenter randomized placebo-controlled
Cheryl T Lee1, Sam S Chang2, Ashish M Kamat3
1University of Michigan, Ann Arbor, MI, USA.
Background:
Radical cystectomy (RC) for bladder cancer is frequently associated with delayed gastrointestinal (GI) recovery that prolongs hospital length of stay (LOS).
Objective:
To assess the efficacy of alvimopan to accelerate GI recovery after RC.
Design, Setting, And Participants:
We conducted a randomized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics.
Intervention:
Oral alvimopan 12 mg (maximum: 15 inpatient doses) versus placebo.
Outcome Measurements And Statistical Analysis:
The two-component primary end point was time to upper (first tolerance of solid food) and lower (first bowel movement) GI recovery (GI-2). Time to discharge order written, postoperative LOS, postoperative ileus (POI)-related morbidity, opioid consumption, and adverse events (AEs) were evaluated. An independent adjudication of cardiovascular AEs was performed.
Results And Limitations:
Patients were randomized to alvimopan (n=143) or placebo (n=137); 277 patients were included in the modified intention-to-treat population. The alvimopan cohort experienced quicker GI-2 recovery (5.5 vs 6.8 d; hazard ratio: 1.8; p<0.0001), shorter mean LOS (7.4 vs 10.1 d; p=0.0051), and fewer episodes of POI-related morbidity (8.4% vs 29.1%; p<0.001). The incidence of opioid consumption and AEs or serious AEs (SAEs) was comparable except for POI, which was lower in the alvimopan group (AEs: 7% vs 26%; SAEs: 5% vs 20%, respectively). Cardiovascular AEs occurred in 8.4% (alvimopan) and 15.3% (placebo) of patients (p=0.09). Generalizability may be limited due to the exclusion of epidural analgesia and the inclusion of mostly high-volume centers utilizing open laparotomy.
Conclusions:
Alvimopan is a useful addition to a standardized care pathway in patients undergoing RC by accelerating GI recovery and shortening LOS, with a safety profile similar to placebo.
Patient Summary:
This study examined the effects of alvimopan on bowel recovery in patients undergoing radical cystectomy for bladder cancer. Patients receiving alvimopan experienced quicker bowel recovery and had a shorter hospital stay compared with those who received placebo, with comparable safety.
Trial Registration:
ClinicalTrials.gov identifier NCT00708201.
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