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Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet]. York (UK): Centre for Reviews and Dissemination (UK); 1995-.

Database of Abstracts of Reviews of Effects (DARE): Quality-assessed Reviews [Internet].

A meta-analysis of the effectiveness of the opioid receptor antagonist alvimopan in reducing hospital length of stay and time to GI recovery in patients enrolled in a standardized accelerated recovery program after abdominal surgery

PG Vaughan-Shaw, IC Fecher, S Harris, and JS Knight.

Review published: 2012.

Link to full article: [Journal publisher]

CRD summary

The review concluded that alvimopan given two hours before surgery and twice daily until discharge could further reduce time to gastrointestinal recovery and hospital discharge in patients undergoing abdominal surgery within an accelerated recovery programme. The authors’ conclusions are based on the evidence and seem reasonable, although the evidence base was small. The authors recommendation for further research appears warranted.

Authors' objectives

To determine the role of alvimopan in accelerating gastrointestinal recovery and discharge after laparoscopic and open abdominal surgery performed within an accelerated recovery programme.

Searching

Four databases including EMBASE and MEDLINE were searched up to 2010 for articles in English. Search terms were reported. Clinical trial registries in Europe and USA were searched. Reference lists of included articles were scanned.

Study selection

Randomised controlled trials (RCTs) of 12mg alvimopan versus placebo in adult patients undergoing abdominal surgery on a defined accelerated recovery programme were eligible for inclusion. Trial had to reporting length of hospital stay as an outcome. Trials that did not adequately describe the recovery protocol or define accelerated were excluded.

Included trials studied 12mg alvimopan versus placebo in adult patients undergoing open bowel resection with primary anastomosis or total abdominal hysterectomy. The mean age of patients ranged from 57 to 61.3 years; the proportion of women ranged from 50% to 64%. The body mass index (BMI) of patients ranged from 27.1 to 29.0kg/m2. The proportion of Caucasian patients ranged from 75% to 88%. Patients predominantly had colorectal disease (where reported); other patients had diverticular disease, Crohn’s disease, or uterine cancer.

Two reviewers undertook full-text study selection.

Assessment of study quality

Trial quality was assessed using the CONSORT guidelines including enrolment, allocation, follow-up and data analysis.

One reviewer undertook quality assessment.

Data extraction

Two reviewers extracted data on time to hospital discharge and recovery of gastrointestinal tract function; these were used to calculate hazard ratios (HRs) and 95% confidence intervals (CIs). Gastrointestinal tract 2 functional recovery was classified as the later of two events: time to tolerating solid food and the time to pass a bowel movement. Gastrointestinal tract 3 functional recovery was classified as the later of two events: time to tolerating solid food and the time to pass flatus or a bowel movement.

Methods of synthesis

Meta-analysis was used to calculate pooled hazard ratios (HRs) with 95% confidence intervals (CIs). Statistical heterogeneity was assessed using Χ² and Ι². Publication bias was assessed using funnel plots.

Results of the review

Three RCTs were included in the review (1,388 patients). The study sample size ranged from 314 to 629 patients. All trials were deemed low risk of bias.

Alvimopan was associated with a statistically significantly reduced time to hospital discharge (HR 1.37, 95% CI 1.23 to 1.52; three RCTs; Ι²=0%), reduced gastrointestinal 3 function recovery (HR 1.42, 95% CI 1.25 to 1.62; three RCTs; Ι²=0%) and reduced gastrointestinal 2 recovery (HR 1.49, 95% CI 1.32 to 1.68; three RCTs; Ι²=0%) compared with placebo.

The authors deemed that the funnel plots showed minimal risk of publication bias.

Authors' conclusions

Alvimopan 12mg given two hours before surgery and twice daily until discharge could further reduce time to gastrointestinal recovery and hospital discharge in patients undergoing abdominal surgery within an accelerated recovery programme.

CRD commentary

Inclusion criteria for the review were clearly defined. Several relevant databases were searched. There may have been the potential for language bias as only articles in English were included. Publication bias was assessed, although the meaningfulness of an analysis with fewer than ten trials was limited. Attempts were made to reduce reviewer error and bias during study selection and data extraction, but not for quality assessment.

Quality assessment of included trials indicated that the quality of the evidence base was generally good. Data were combined using meta-analysis, although the exact methods were unclear. Statistical heterogeneity was not detected in any of the analyses.

The authors’ conclusions are based on the evidence and seem reasonable, although the evidence base was small. The authors recommendation for further research appears warranted.

Implications of the review for practice and research

Practice: The authors did not state any implications for practice.

Research: The authors stated that the effect of alvimopan following laparoscopic surgery and the potential for adverse cardiovascular events with alvimopan required further research. The cost-benefit of treatment also needed to be determined.

Funding

Not reported.

Bibliographic details

Vaughan-Shaw PG, Fecher IC, Harris S, Knight JS. A meta-analysis of the effectiveness of the opioid receptor antagonist alvimopan in reducing hospital length of stay and time to GI recovery in patients enrolled in a standardized accelerated recovery program after abdominal surgery. Diseases of the Colon and Rectum 2012; 55(5): 611-620. [PubMed: 22513441]

Indexing Status

Subject indexing assigned by NLM

MeSH

Digestive System Surgical Procedures; Gastrointestinal Tract /physiology; Humans; Length of Stay /trends; Piperidines /pharmacology; Postoperative Care /methods; Program Evaluation; Receptors, Opioid, mu /antagonists & inhibitors; Recovery of Function /drug effects; Treatment Outcome

AccessionNumber

12012032633

Database entry date

09/01/2013

Record Status

This is a critical abstract of a systematic review that meets the criteria for inclusion on DARE. Each critical abstract contains a brief summary of the review methods, results and conclusions followed by a detailed critical assessment on the reliability of the review and the conclusions drawn.

CRD has determined that this article meets the DARE scientific quality criteria for a systematic review.

Copyright © 2014 University of York.

PMID: 22513441

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