Trial reportSurgical endoscopy2006
Alvimopan, a peripherally acting mu-opioid receptor antagonist, compared with placebo in postoperative ileus after major abdominal surgery: results of a randomized, double-blind, controlled study.
Trial report in Surgical endoscopy, 2006. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to 4 registered trials, which are not on this map. Cited by 44 papers, 5 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Multicenter Phase III, Double-Blind, Placebo-Controlled, Parallel Study of ADL-8-2698 in Opioid-Induced Postoperative Bowel Dysfunction/Postoperative Ileus
A Randomized Trial of Alvimopan for the Reduction of Ileus After Long Posterior Spinal Fusion
Randomized, Double-Blind, Placebo-Controlled Trial of Alvimopan in Major Spine Surgery
Comparison Between Intraperitoneal Versus Intramuscular Neostigmine on Pattern of Postoperative GIT Motility in Patients Undergoing Laparoscopic Cholecystectomy
Who cites it
44 citing papers in PubMed, 5 syntheses or guidelines pooled it, 188 citations in OpenAlex.
- Alvimopan for postoperative ileus following abdominal surgery: a systematic review.Langenbeck's archives of surgery · 2024Pooled it
- Pooled it
- Pooled it
- Pharmacological management to prevent ileus in major abdominal surgery: a systematic review and meta-analysis.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2016Pooled it
- Defining postoperative ileus: results of a systematic review and global survey.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2013Pooled it
- Evaluation of TU-100 (Daikenchuto), a Traditional Japanese Kampo Medicine, as an Adjunct to Enhanced Recovery After Surgery, for Acceleration of Gastrointestinal Recovery After Bowel Resection: Results of a Proof-of-Concept, Phase 2, Randomized, Double-Blinded, Placebo-Controlled Trial.Diseases of the colon and rectum · 2026Trial
- Alvimopan for the management of postoperative ileus after bowel resection: characterization of clinical benefit by pooled responder analysis.World journal of surgery · 2010Trial
- Effect of bisacodyl on postoperative bowel motility in elective colorectal surgery: a prospective, randomized trial.International journal of colorectal disease · 2008Trial
- Mismatch of populations between randomised controlled trials of perioperative interventions in major abdominal surgery and current clinical practice.Perioperative medicine (London, England) · 2023Review
- Alvimopan is associated with favorable outcomes in open and minimally invasive colorectal surgery: a regional database analysis.Surgical endoscopy · 2023Article
- Peripherally Acting μ-Opioid Receptor Antagonists in the Management of Postoperative Ileus: a Clinical Review.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2021Review
- Effect of alvimopan on gastrointestinal recovery and length of hospital stay after retroperitoneal lymph node dissection for testicular cancer.Journal of clinical urology · 2019Article
- Alvimopan, Regardless of Ileus Risk, Significantly Impacts Ileus, Length of Stay, and Readmission After Intestinal Surgery.Journal of gastrointestinal surgery : official journal of the Society for Surgery of the Alimentary Tract · 2018Article
- A Retrospective Study of Patients Undergoing Radical Cystectomy and Receiving Peri-Operative Naloxegol or Alvimopan: Comparison of Length of Stay.Journal of surgery (New York, N.Y.) · 2018Article
- Clinical practice guideline for enhanced recovery after colon and rectal surgery from the American Society of Colon and Rectal Surgeons (ASCRS) and Society of American Gastrointestinal and Endoscopic Surgeons (SAGES).Surgical endoscopy · 2017Article
- Redefining the implications of nasogastric tube placement following radical cystectomy in the alvimopan era.World journal of urology · 2017Article
- Alvimopan Use, Outcomes, and Costs: In reply to Fujita.Journal of the American College of Surgeons · 2016Article
- Gastrointestinal Complications in Patients Who Undergo Radical Cystectomy with Enhanced Recovery Protocol.Current urology reports · 2016Review
- Alvimopan Use, Outcomes, and Costs: A Report from the Surgical Care and Outcomes Assessment Program Comparative Effectiveness Research Translation Network Collaborative.Journal of the American College of Surgeons · 2016Article
- Comprehensive enhanced recovery pathway significantly reduces postoperative length of stay and opioid usage in elective laparoscopic colectomy.Surgical endoscopy · 2015Article
Corrections and comments
- Erratum issued
Authors and funding
9 authors at 3 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundAlvimopan is a peripherally acting mu-opioid receptor (PAM-OR) antagonist for accelerating gastrointestinal recovery after surgery.
methodsPatients undergoing open laparotomy (bowel resection, n = 418; hysterectomy, n = 197) were randomized to receive alvimopan 6 or 12 mg or placebo orally > or = 2 h before surgery and then b.i.d. until hospital discharge (up to 7 days). The primary efficacy endpoint was time to gastrointestinal (GI) recovery (measured by toleration of solid food and passage of flatus/stool; GI-3). Secondary endpoints included time to GI-2 recovery (toleration of solid food and passage of stool) and hospital discharge order written (DCO).
resultsAlvimopan did not significantly accelerate GI-3 compared with placebo [6 mg: hazard ratio (HR) = 1.20, p = 0.080; 12 mg: HR = 1.24, p = 0.038). However, after adjustment for significant covariates (sex/surgical duration), benefits were significant for both doses (6 mg: HR = 1.24, p = 0.037; 12 mg: HR = 1.26, p = 0.028). Alvimopan also significantly accelerated time to GI-2 (6 mg: HR = 1.37, p = 0.008; 12 mg: HR = 1.33, p = 0.018) and DCO (6 mg: HR = 1.31, p = 0.008; 12 mg: HR = 1.28, p = 0.015). Adverse events were similar between groups.
conclusionsAlvimopan (6 or 12 mg) accelerates GI recovery and is well tolerated in patients undergoing open laparotomy.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.