Alvimopan Group Research Articles

Alvimopan is associated with favorable outcomes in open and minimally invasive colorectal surgery: a regional database analysis.

Alvimopan is a µ-opioid receptor antagonist associated with shorter time to gastrointestinal recovery in patients having open colorectal surgery. Data demonstrating the benefit of perioperative alvimopan for the minimally invasive surgical approach are inconsistent. The aim of this study is to determine colorectal surgery groups that benefit from perioperative alvimopan. This is a retrospective cohort analysis of colorectal surgery patients who had, and patients who did not have, perioperative alvimopan in the Michigan Surgical Quality Collaborative regional risk-adjusted database from 2018 through 2021. Main outcome measures were postoperative length of hospital stay, time to return of bowel function, and postoperative ileus. There were 10,010 patients (30.3% open, 40.5% laparoscopic, 12.7% hand-assist laparoscopic, 43.5% robotic) who met inclusion criteria-4919 received alvimopan in the perioperative period and 5091 did not. When compared to those not receiving alvimopan, unadjusted outcomes showed that the alvimopan group had significantly shorter postoperative length of stay (4.75days vs 5.5days, p < 0.001), shorter time to return of bowel function (1.61days vs 2.01days, p < 0.001) and less postoperative ileus (5.45% vs 7.94%, p < 0.001). After adjustment, regression models confirmed that alvimopan was associated with an 9.6% reduction in hospital length of stay (p < 0.001), a 14.9% shorter time to return of bowel function (p < 0.001), and a 42.1% reduction in postoperative ileus (p < 0.001). Subgroup analysis showed significant benefit of alvimopan for all three outcomes in patients having the minimally invasive approach. Alvimopan is associated with shorter hospital length of stay, shorter time to return of bowel function, and decreased postoperative ileus when administered to patients undergoing colorectal surgery. Benefit is not limited to the open approach and includes minimally invasive laparoscopic and robotic colorectal procedures.

Efficacy and safety of alvimopan use in benign urinary tract reconstruction.

To analyze the use of alvimopan, a peripheral mu-opioid receptor antagonist, in expediting gastrointestinal recovery after benign abdominal urinary tract reconstruction. Alvimopan use has been well defined in the management of radical cystectomy and urinary diversion for oncologic indications. It has not been studied in benign abdominal genitourinary reconstruction. Patients who underwent urinary reconstruction utilizing harvested bowel segments for benign conditions from 12/2014-7/2019 were retrospectively reviewed. From 5/2018-7/2019 our institution approved the use of perioperative alvimopan in the aforementioned patients (N = 11), who were paired 1:2 with patients from a cohort of alvimopan-eligible patients who did not receive the drug (N = 22). Patients were paired by (1) type of reconstruction and (2) presence of neurogenic bowel-bladder (NBB). Of the 70 patients who underwent urinary reconstruction during the study period, 46 patients (66%) were eligible to receive alvimopan. Length of stay was shorter for the alvimopan group compared to the non-alvimopan group (median 5days [IQR 4-5days] vs. 8days [IQR 6-11days]; P = 0.002). Time to first bowel movement was shorter for the alvimopan group (median 4days [IQR 3-4days] vs. 6days [IQR 4-7], P = 0.001). No patient treated with alvimopan required a nasogastric (NG) tube for post-operative ileus compared to 7 (32%) patients in the non-treatment group (P = 0.035). Post-operative complications and 30-day readmissions were similar between the two groups. The use of perioperative alvimopan in benign abdominal urinary tract reconstruction expedited return of bowel function and decreased length of stay compared to a matched cohort of untreated patients.

Alvimopan as an essential component of ERAS protocol to decrease length of hospital stay.

517 Background: Radical cystectomy for muscle invasive bladder cancer is the gold standard. However, it is frequently associated with a prolonged length of hospital stay (LOS). We study the effect of ERAS protocol implementations and Alvimopan use in patients undergoing radical cystectomy and its impact on length of hospital stay (LOS). Methods: Retrospective cohort study involving consecutive patients undergoing radical cystectomy for bladder cancer at our institution from 2010 through 2018. We evaluated Alvimopan use plus an ERAS protocol post radical cystectomy versus patients who underwent ERAS protocol alone versus those who were managed prior to ERAS protocol implementation. Primary outcome of interest was LOS, controlling for age, sex, smoking status and Charleson comorbidities index. Results: 146 patients (49.32 %) received standard care (non-ERAS) (group A), 102 patients (34.45 %) underwent ERAS protocol alone (group B) and 47 patients (15.87 %) underwent ERAS protocol plus Alvimopan (group C). There was no significant difference in length of stay between group A and group B (p=0.856). However, group C experienced a shorter LOS (16.6%) compared to group A (p=0.015). Similarly, group B was not significantly associated with the days to bowel movements compared to group A (p=0.112), however, group C demonstrated a significantly shorter time (16.3%) to bowel movements compared to group A (p=0.015). On other hand, group c wasn’t significantly associated with time tolerance to regular diet (p=0.068). Limitations include retrospective nature of some of the data, non-randomized approach and confounders such as a mix of robot and open approaches to cystectomy. Conclusions: Of all ERAS protocol components, Alvimopan appeared to be the most significant contributor in accelerating GI recovery and decrease LOS in our cohort.

Alvimopan for the Prevention of Postoperative Ileus in Inflammatory Bowel Disease Patients.

Postoperative ileus (POI) is a temporary delay of coordinated intestinal peristalsis. Alvimopan, an oral peripherally acting mu-opioid receptor antagonist approved for accelerating gastrointestinal recovery, has never been studied specifically in patients with inflammatory bowel disease (IBD). To investigate the efficacy of alvimopan in preventing POI among IBD patients. A retrospective chart review was conducted on 246 IBD patients undergoing bowel surgery between 2012 and 2017. Data collected included demographics, IBD subtype, length of stay (LOS), postoperative gastrointestinal symptoms, and administration of alvimopan. The primary outcome was POI; secondary gastrointestinal recovery outcomes were: time to first flatus, time to first bowel movement, time to tolerating a liquid diet, time to tolerating solid food, and LOS. When compared with the control group, patients in the alvimopan group had shorter times to tolerating liquids and solids, first flatus, and first bowel movements (p < 0.01). LOS was shorter in the alvimopan group when compared with controls (p < 0.01). The overall incidence of POI was higher in controls than in the alvimopan group (p = 0.07). For laparoscopic surgeries, the incidence of POI was also higher in controls than in the alvimopan group (p < 0.01). On multivariable analysis, alvimopan significantly decreased time to all gastrointestinal recovery endpoints when compared to controls (p < 0.01). Alvimopan is effective in accelerating time to gastrointestinal recovery and reducing POI in IBD patients. While the benefits of alvimopan have been demonstrated previously, this is the first study of the efficacy of alvimopan in IBD patients.

The Impact of Alvimopan on Return of Bowel Function After Major Spine Surgery - A Prospective, Randomized, Double-Blind Study.

Pain management following major spine surgery requires high doses of opioids and is associated with a risk of opioid-induced constipation. Peripheral mu-receptor antagonists decrease the gastrointestinal complications of perioperative systemic opioid administration without antagonizing the analgesic benefits of these drugs. To investigate the impact of alvimopan in opioid-naive patients undergoing major spine surgery. Patients undergoing>3 levels of thoracic and/or lumbar spine surgery were enrolled in this prospective, randomized, double-blind study to receive either alvimopan or placebo prior to and following surgery. Opioid consumption; pain scores; and time of first oral intake, flatus, and bowel movement were recorded. A total of 24 patients were assigned to the active group and 25 were assigned to the placebo group. There was no significant difference in demographics between the groups. Postoperatively, the alvimopan group reported earlier time to first solid intake [median (range): alvimopan: 15 h (3-25) vs placebo: 17 h (3-46), P<.001], passing of flatus [median (range): alvimopan: 22 h (7-63) vs placebo: 28 h (10-58), P<.001], and first bowel movement [median (range): alvimopan: 50 h (22-80) vs placebo: 64 h (40-114), P<.001]. The alvimopan group had higher pain scores (maximum, minimum, and median); however, there was no significant difference between the groups with postoperative opioid use. This study shows that the perioperative use of alvimopan significantly reduced the time to return of bowel function with no increase in postoperative opioid use despite a slight increase in pain scores.

Alvimopan Significantly Reduces Length of Stay and Costs Following Colorectal Resection and Ostomy Reversal Even Within an Enhanced Recovery Protocol.

Alvimopan accelerates GI recovery after colorectal resection. Data on real-world cost-effectiveness have been mixed. This study aimed to evaluate if adding alvimopan to an enhanced recovery pathway reduces length of stay. Patients undergoing colorectal resection or ostomy reversal for the year before and after the introduction of alvimopan were evaluated. This study was conducted at a single academic medical center. Patients undergoing elective colorectal resection (488) or ostomy reversal (148) were included. The primary outcomes measured were length of stay and prolonged length of stay defined as >75th percentile for each procedure. Two hundred eighty-six patients (45%) received alvimopan. Alvimopan and no-alvimopan groups had similar demographics, comorbidities, operative indication, and case mix. In the alvimopan group, more of the colorectal resections were laparoscopic (87% vs 79%, p = 0.015). Length of stay was reduced with alvimopan (6.2 vs 4.9 days, p = 0.003), and this effect persisted when controlling for procedure type, approach, and ASA class (decreased length of stay by 1.0 day, p = 0.014). The alvimopan group had lower risk of prolonged length of stay (14.7% vs 23.1%, p = 0.007) and ileus (10.8% vs 16.2%, p = 0.05). On multivariable analysis, no alvimopan use (OR, 1.8; 95% CI, 1.2-2.7), ASA ≥3 (OR, 2.0; 95% CI, 1.3-3.1), and history of cardiac surgery (OR, 2.8; 95% CI, 1.2-6.5) were significant predictors of prolonged length of stay. Alvimopan use was associated with a lower risk of infectious complications other than surgical site infection (2.8% vs 6.7%, p = 0.025), and did not increase risk of any adverse outcomes. The addition of alvimopan to the protocol resulted in cost savings of $708.39 per patient. Data collected from a single center limit external validity. The introduction of alvimopan to a postoperative protocol following elective colorectal resection or ostomy reversal significantly reduces length of stay and is associated with cost savings even within an enhanced recovery protocol. See Video Abstract at http://links.lww.com/DCR/A911.

The Use of Alvimopan as Prophylaxis against Post-Operative Ileus After Bowel Resection in Patients With Inflammatory Bowel Disease

BACKGROUND: Postoperative ileus (POI) is a temporary delay of coordinated intestinal peristalsis following major abdominal surgery, leading to significant symptoms such as nausea, vomiting, abdominal pain, prolonged hospitalization, nosocomial complications, and physical deconditioning. The use of opioids for postoperative pain control further exacerbates the problem. Opioids bind to the mu receptors in the intestinal tract, leading to gut hypomotility. Alvimopan, an oral, peripherally acting mu-opioid receptor antagonist, was FDA approved in 2008 for use before and after bowel resection to help prevent and treat POI. There are no dedicated studies of alvimopan in patients with inflammatory bowel disease (IBD). Therefore, we conducted a study to investigate alvimopan's role in IBD patients who underwent either laparoscopic or open bowel resection. METHODS: A retrospective chart review was conducted at a 725-bed acute care teaching hospital in New York City between January 2012 and February 2017. Data collected included age, sex, type of IBD, length of stay, post-operative gastrointestinal symptoms (nausea, vomiting, constipation, abdominal distention, first flatus, first bowel movement, PO tolerance), and dose of alvimopan, were collected. The primary outcome was time to GI recovery. Secondary outcomes were: time to first flatus, time to first bowel movement, time to tolerating a liquid diet, time to tolerating solid food, and total length of stay. Descriptive statistics reports were created through a secure web-based application called REDCap (Research Electronic Data Capture), and the data were exported into Stata to run further analyses. Of note, approximately 50% of patients who underwent bowel surgery after March 2015 were placed on a “colon surgery pathway”, which is an order set dedicated to strategies that decrease length of stay and post-operative complications. Key features include early feeding, optimized analgesia regimen to allow patients to ambulate, encouraging use of incentive spirometry, and administration of alvimopan peri-procedurally. RESULTS: Of 247 patients, 121 received alvimopan (49.0%) and 126 (51.0%) did not. The male to female ratio was 51:49. The mean age of the control group was 44.4 ± 16.3 and that of the alvimopan group was 43.2 ± 16.4. Patients who received alvimopan had faster GI recovery, with a hazard ratio (HR) of 2.11 (P<0.001), shorter time to first flatus (HR 2.02, P<0.001), shorter time to first bowel movement (HR 1.93, P<0.001), shorter time to tolerating liquid diet (HR 2.48, P<0.001), and shorter time to tolerating solid food (HR 2.00, P<0.001). After controlling for type of bowel resected (large vs. small bowel), laparoscopic vs. open, age, and type of IBD (ulcerative colitis vs. Crohn's disease) using linear regression, patients who received alvimopan spent 2.59 fewer days in the hospital compared to the control group (P<0.01). CONCLUSION(S): The results of this study suggest that alvimopan is effective in accelerating the time to GI recovery. Data analysis of all primary and secondary outcomes revealed that alvimopan had a statistically significant benefit during the post-operative period of IBD patients undergoing bowel resection. Length of stay for IBD patients was significantly decreased with peri-operative use of alvimopan.

Alvimopan in the setting of colorectal resection with an ostomy: To use or not to use?

Postoperative ileus (POI) is a major cause of morbidity, increased length of stay (LOS) and hospital cost after colorectal surgery. Alvimopan is a µ-opioid antagonist used to accelerate upper and lower gastrointestinal function after bowel resection. We hypothesized that alvimopan would reduce LOS in patients undergoing colorectal resection with stoma, a situation that has not been evaluated. A retrospective review (2010-2015) identified 58 patients who underwent colorectal resection for benign or malignant disease with stoma creation and received alvimopan. They were case-matched to 58 non-alvimopan patients based on age, BMI, baseline comorbidities, stoma type created and surgical approach. We compared overall LOS, incidence of POI and other postoperative complications. There were equal numbers of laparoscopic (N=18) and open resections (N=40) in the alvimopan group and non-alvimopan group. There were also equal numbers of patients with an ileostomy (N=37) or colostomy (N=21) in each group. Overall, 41 patients underwent resection for malignant disease in the alvimopan group compared to 37 in the non-alvimopan group. There was a significant reduction in median LOS overall (alvimopan 5 (4-7) versus control 6 (4.75-9.25) days, P=0.03). While the 6-day median LOS was similar for patients undergoing ileostomy creation (P=0.25), alvimopan patients had a 3-day decreased median LOS that approached statistical significance (P=0.06). The overall 30-day complication rate was higher in the control group (41.4 vs. 51.7%, P=0.26), but the readmission rate within 30days was higher in the alvimopan group (19 vs. 13.8%, P=0.45). Neither of these differences reached statistically significance. The use of alvimopan in patients undergoing colorectal resection with stoma is associated with a significantly shorter LOS, but the increased readmission rate warrants further study. Based on these data, alvimopan should be evaluated in a controlled setting for patients undergoing colorectal resection with colostomy creation.

Is there value in alvimopan in minimally invasive colorectal surgery?

BackgroundAlvimopan's goal is to minimize postoperative ileus and optimize outcomes; however, evidence in laparoscopic surgery is lacking. Our goal was to evaluate the benefit of alvimopan in laparoscopic colorectal surgery with an enhanced recovery pathway (ERP). MethodsLaparoscopic colorectal cases were stratified into alvimopan and control cohorts, then case-matched for comparability. All followed an identical ERP. The main outcomes were length of stay, complications, readmissions, and costs in the alvimopan and control groups. ResultsAbout 321 patients were analyzed in each cohort. Operative times were comparable (P = .08). Postoperatively, complication rates were similar (P = .29), with no difference in ileus (P = 1.00). The length of stay (3.69 vs 3.49 days; P = .16), readmission (2.8% vs 3.7%; P = .66) and reoperation rates (2.2% vs 1.6%; P = .77) were comparable for alvimopan and controls, respectively. Total costs were similar ($14,932.47 alvimopan vs $14,846.56 controls; P = .90), but the additional costs in the alvimopan group could translate to savings of $27,577 in the cohort. ConclusionsAlvimopan added no benefit in patient outcomes in laparoscopic colorectal surgery with an ERP. These results could drive a change in current practice. Controlled studies are warranted to define the cost and/or benefit in clinical practice.

Alvimopan combined with enhanced recovery strategy for managing postoperative ileus after open abdominal surgery: a systematic review and meta-analysis

BackgroundTo assess the efficacy and safety of alvimopan in conjunction with enhanced recovery strategy, compared with this strategy alone, in management of postoperative ileus in patients undergoing open abdominal surgery. MethodsElectronic databases were comprehensively searched for relevant randomized controlled trials. We were interested in doses of 6 and 12 mg. The efficacy end points included the time to recovery of full gastrointestinal (GI) function (a composite end point measured by the time to first toleration of solid food [SF] and the time to first passage of stool, GI-2), the recovery of upper (SF) or the lower (the time to first bowel movement, BM) GI function, and the length of hospital stay (the time to discharge order written). Safety end points included GI-related, non-GI–related, and serious adverse events. These parameters were all analyzed by RevMan 5.3 software. ResultsNine randomized controlled trials involving 4075 patients were enrolled in this study. The pooled results showed that alvimopan significantly decreased the time to GI-2 recovery (6 mg, hazard ratio [HR] = 1.45, P < 0.00001; 12 mg, HR = 1.59, P < 0.00001), BM (6 mg, HR = 1.54, P < 0.00001; 12 mg, HR = 1.74, P = 0.0002), and the time to discharge order written (6 mg, HR = 1.37, P < 0.00001; 12 mg, HR = 1.34, P < 0.00001) compared with the placebo group. However, SF was significantly reduced in 6 mg group (HR = 1.23, P = 0.008) rather than 12 mg group (HR = 1.14, 95% confidence interval 1.00, 1.30, P = 0.04). The incidence of some GI-related and serious adverse events were significantly lower in the alvimopan group than the placebo group, and the dose of 12 mg was superior to 6 mg in this regard. ConclusionsAlvimopan can accelerate recovery of GI function (especially for the lower GI tract), shorten the length of hospital stay, and reduce postoperative ileus-related morbidity without compromising opioid analgesia in an enhanced recovery setting.

Effect of alvimopan on return of bowel function after robot-assisted radical cystectomy.

Alvimopan has been shown to improve time to return of bowel function in patients undergoing bowel resection. The objective of this study is to determine if alvimopan has similar benefits for patients undergoing robot-assisted radical cystectomy (RARC). All RARC cases were reviewed from January 2008 to March 2012. All patients during this time were administered alvimopan unless they had been receiving narcotics preoperatively. Patients receiving alvimopan received a preoperative dose of 12 mg perorally and then were dosed twice daily for 7 days or until first bowel movement. Clinicopathologic outcomes were summarized and compared, and functional outcomes of treated patients were compared with outcomes of untreated patients. One hundred seventeen RARCs meeting study criteria were performed. All urinary diversions used an extracorporeal approach. Urinary diversions consisted of 50 Studer neobladders, 22 Indiana pouches, and 45 ileal conduits. Fifty-four patients received alvimopan, and 63 did not. The median time to first bowel movement was 5 days in the alvimopan group and 6 days in the untreated group (P=.03). Median time to solid diet was 6 days in the treated group and 7 days in the untreated group (P=.03). There was a trend toward fewer hospital days in the alvimopan group (alvimopan, 8 days; untreated, 9 days; P=.1). Alvimopan administration appears to reduce the time to return of bowel function and initiation of diet following RARC. This was a trend toward shorter hospitalization in the alvimopan group. Alvimopan should be considered in ongoing research into protocols to aid in shorter convalescence following RARC.

MP60-07 THE ROLE OF ALVIMOPAN FOR RADICAL CYSTECTOMY

You have accessJournal of UrologyBladder Cancer: Invasive III1 Apr 2014MP60-07 THE ROLE OF ALVIMOPAN FOR RADICAL CYSTECTOMY Zachary Hamilton, Josh Griffin, Moben Mirza, and Jeffrey Holzbeierlein Zachary HamiltonZachary Hamilton More articles by this author , Josh GriffinJosh Griffin More articles by this author , Moben MirzaMoben Mirza More articles by this author , and Jeffrey HolzbeierleinJeffrey Holzbeierlein More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1761AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives Radical cystectomy is a major surgical procedure that results in delayed return of bowel function, due to primary intestinal anastomosis. Alvimopan (Entereg) is an FDA approved peripherally acting μ-opiod receptor antagonist that has shown favorable results for improved recovery of gastrointestinal function and decreased hospital length of stay, including studies specifically examining radical cystectomy. We aim to retrospectively review our experience utilizing Alvimopan with patients undergoing radical cystectomy for bladder cancer. Methods A retrospective review was performed of patients undergoing radical cystectomy at our institution. Patients were routinely provided with Alvimopan 12mg once preoperatively and twice daily postoperatively for a maximum of seven days. At our institution, radical cystectomy patients were routinely started on a clear liquid diet on postoperative day two, and a regular diet was given after return of bowel activity, evidenced by flatus or bowel movement. Time from initiation of clear liquid diet to tolerance of regular diet was recorded, as was total length of hospitalization. An unpaired t-test was utilized for statistics. Results A total of 40 patients were given Alvimopan and 60 patients did not receive Alvimopan from July 2011 to January 2013. Mean age for the Alvimopan cohort was 67.5 years and 67.7 years in the non-Alvimopan cohort. The Alvimopan cohort contained 78% male and 22% female. The non-Alvimopan cohort contained 73.3% male and 26.7% female. The mean length of time until tolerance of regular diet in the Alvimopan cohort was 2.3 days, yet it was 3.1 days in the non-Alvimopan cohort (p=0.036). Mean length of hospitalization for the Alvimopan cohort was 5.9 days, while it was 6.6 days in the non-Alvimopan cohort (p=0.084). The median number of doses received was nine, which leads to an additional cost of $846 in the Alvimopan group. If patients received the maximum number of doses (fifteen), the additional cost in the Alvimopan group was $1410. Conclusions When utilized for patients undergoing radical cystectomy, Alvimopan seem to provide the advantage of decreased time to tolerance of regular diet, but holds no difference in time to hospital discharge and is associated with increased cost. Further prospective studies, including in-depth cost analysis, are needed to determine the most useful indication for this medication. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e635 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Zachary Hamilton More articles by this author Josh Griffin More articles by this author Moben Mirza More articles by this author Jeffrey Holzbeierlein More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

MP55-10 GASTROINTESTINAL RECOVERY USING PERIOPERATIVE ALVIMOPAN WITH ROBOTIC CYSTECTOMY AND URINARY DIVERSION

You have accessJournal of UrologyBladder Cancer: Invasive II1 Apr 2014MP55-10 GASTROINTESTINAL RECOVERY USING PERIOPERATIVE ALVIMOPAN WITH ROBOTIC CYSTECTOMY AND URINARY DIVERSION Daniel Swanson, Ross E. Anderson, Ann C. Martinez Acevedo, Jeffrey C. La Rochelle, Theresa M. Koppie, and Christopher L. Amling Daniel SwansonDaniel Swanson More articles by this author , Ross E. AndersonRoss E. Anderson More articles by this author , Ann C. Martinez AcevedoAnn C. Martinez Acevedo More articles by this author , Jeffrey C. La RochelleJeffrey C. La Rochelle More articles by this author , Theresa M. KoppieTheresa M. Koppie More articles by this author , and Christopher L. AmlingChristopher L. Amling More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2014.02.1558AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail Introduction and Objectives Postoperative ileus contributes significantly to the morbidity associated with radical cystectomy and urinary diversion. Alvimopan, a peripheral acting μ-opioid receptor antagonist, has been shown to accelerate gastrointestinal recovery following bowel resection. Robotic cystectomy may also shorten postoperative ileus compared to open cystectomy. We investigate gastrointestinal recovery and length of hospital stay (LOS) using perioperative alvimopan with particular attention to whether there is added benefit to this drug in patients undergoing robotic cystectomy and urinary diversion. Methods Over a two year period (2011-2013), a total of 58 patients with bladder cancer underwent robotic cystectomy with urinary diversion. Of this group, 37 did not receive perioperative alvimopan while 21 more recently treated patient got alvimopan starting preoperatively and continued postoperatively as directed. All patients received the standard bowel recovery protocol. Return of bowel function, defined by time to first flatus and time to bowel movement (BM), was compared between these groups. Hospital LOS and gastrointestinal complications were also evaluated. Results There was no difference between alvimopan-treated or untreated groups with regard to gender distribution, age, BMI, bladder cancer pathologic stage or urinary diversion option. There was no difference between the groups with regard to operative time, estimated blood loss, or intravenous fluid volume. Time to first flatus (2.5 versus 3.6 days, p=0.001) and bowel movement (3.3 versus 4.7 days, p=0.001) were significantly shorter in those patients who received alvimopan. In addition, hospital LOS (4.5 versus 7.5 days, p=0.009) was significantly reduced in the alvimopan cohort. There were no patients with prolonged ileus in the alvimopan group and no difference between the groups in hospital readmission rates or gastrointestinal complications. Conclusions In our experience, perioperative use of alvimopan significantly accelerates gastrointestinal recovery and hospital discharge, even in patients undergoing robotic cystectomy which itself is associated with a shorter hospital stay than open cystectomy at our institution. The combination of a robotic approach and perioperative alvimopan may result in the shortest possible time to bowel recovery and hospital discharge, reducing cost and limiting perioperative complications. © 2014FiguresReferencesRelatedDetails Volume 191Issue 4SApril 2014Page: e559 Advertisement Copyright & Permissions© 2014MetricsAuthor Information Daniel Swanson More articles by this author Ross E. Anderson More articles by this author Ann C. Martinez Acevedo More articles by this author Jeffrey C. La Rochelle More articles by this author Theresa M. Koppie More articles by this author Christopher L. Amling More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Alvimopan Accelerates Gastrointestinal Recovery After Radical Cystectomy: A Multicenter Randomized Placebo-Controlled Trial

BackgroundRadical cystectomy (RC) for bladder cancer is frequently associated with delayed gastrointestinal (GI) recovery that prolongs hospital length of stay (LOS). ObjectiveTo assess the efficacy of alvimopan to accelerate GI recovery after RC. Design, setting, and participantsWe conducted a randomized double-blind placebo-controlled trial in patients undergoing RC and receiving postoperative intravenous patient-controlled opioid analgesics. InterventionOral alvimopan 12mg (maximum: 15 inpatient doses) versus placebo. Outcome measurements and statistical analysisThe 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 limitationsPatients 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. ConclusionsAlvimopan 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 summaryThis 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 registrationClinicalTrials.gov identifier NCT00708201

Alvimopan: A cost-effective tool to decrease cystectomy length of stay.

IntroductionWe sought to evaluate the cost effectiveness of perioperative use of alvimopan in cystectomy and urinary diversion. A recent randomized controlled trial demonstrated the efficacy of alvimopan in reducing postoperative ileus and length of stay in cystectomy; however, a major limitation was the exclusion of epidural analgesia.Materials and methodsEighty–six cystectomy and urinary diversion procedures performed by seven surgeons were analyzed between January 2008 and April 2012. The first 50 patients did not receive alvimopan perioperatively, while the subsequent 36 received a single dose of 12 mg preoperatively and then 12 mg every 12 hours for 15 doses or until discharge.ResultsThe groups were equal with respect to age, gender, indication, surgeon, and type of diversion. Patients who received alvimopan experienced a shorter length of stay (LOS) versus those in who did not receive alvimopan (10.5 vs. 8.6 days, p = 0.005, 95% CI 0.6–3.3). Readmission for ileus was low in both alvimopan and control groups (0% and 4.4%, respectively). Costs were significantly lower in the alvimopan group than the control groups (2012 USD 32,443 vs. 40,604 p <0.001). This difference stood up to multivariate analysis with a $7,062 difference in hospital stay.ConclusionsUse of alvimopan in the routine perioperative care of our cystectomy and urinary diversion patients has decreased LOS by 1.9 days. Additionally, institution of routine perioperative alvimopan has reduced costs by $7,062 per admission (20% reduction). This demonstrates a real world application of alvimopan at a moderate volume center.

Fast-track Pathway for Minimally Invasive Colorectal Surgery with and without Alvimopan (Entereg)™: Which is More Cost-effective?

Multimodal fast-track (FT) pathways for both open and laparoscopic colorectal surgery have been shown to improve gastrointestinal recovery, shorten length of stay, and decrease morbidity. The aim of our study was to determine if using alvimopan (Entereg)™ in the setting of a FT minimally invasive colorectal pathway is beneficial and cost-effective. All minimally invasive colorectal surgeries performed by one surgeon using a multimodal FT pathway with and without alvimopan were reviewed. Ninety total patients were identified, 64 patients treated without and 26 with alvimopan. Main outcomes included postoperative day tolerating a soft diet, return of gastrointestinal function, length of stay, 30-day readmission rate, and patient care, anesthesia, pharmacy, and combined cost. Tolerance of a soft diet, return of gastrointestinal function, and length of stay were all shorter and showed significance in the alvimopan group (mean 2.1 vs 2.8 days, mean 1.5 vs 2.4 days, and mean 3.5 vs 4.5 days, respectively) (P = 0.0197, P = 0.0029, and 0.0158, respectively). Patient care and combined hospital costs were both increased in the nonalvimopan group; however, combined hospital costs was not significant (P = 0.0216 and P = 0.0875, respectively). The 30-day readmission rate of 6.3 per cent was also not significant in this group (P = 0.0941). Patients undergoing minimally invasive colorectal surgery treated with a multimodal FT pathway tolerated a soft diet sooner, had earlier return of bowel function, a shorter length of stay, and lower patient care and combined costs when alvimopan was used.

A Preliminary Investigation: Alvimopan Use to Prevent Post-Operative Ileus after Radical Cystectomy with Urinary Diversion

Background: Postoperative ileus (POI) is a common and frustrating patient complication after a urinary diversion by using a segment of bowel. Alvimopan is an oral selective antagonist to the peripheral μ-opioid receptor. Our study investigates the effect of alvimopan on POI in patients undergoing radical cystectomy. There are no documented studies on alvimopan’s efficacy in urologic surgery literature. Methods: Approval from the Institutional Review Board was obtained to conduct a retrospective review of patients’ records from August 2009 until August 2011. The study included sixteen patients who had undergone radical cystectomy with ileal diversion. Exclusion criteria included patients with chronic opioid use, previous colostomy or ileostomy, or significant comorbidities which could cause increased postoperative complications. Statistical analysis was performed to examine the association of alvimopan use with decreased time to dietary advancement and decreased length of hospital stay. Results: The alvimopan group advanced their diet more than 24 hours earlier in comparison with the alvimopan naive group (P Interpretation: To our knowledge we report one of the first uses of alvimopan in reducing POI in the urological surgery literature. Our novel experience with using this drug is encouraging. Further research will ultimately determine if standard use of alvimopan to decrease POI in radical cystectomy with ileal diversion will be implemented.

Evaluation of Clinical Outcomes With Alvimopan in Clinical Practice

To evaluate in-hospital clinical outcomes after open and laparoscopic bowel resection (BR) with or without alvimopan treatment. Delayed return of gastrointestinal function after BR may be associated with greater postoperative morbidity and increased hospital length of stay (LOS). In clinical trials, alvimopan--a peripherally acting μ-opioid receptor antagonist--accelerated gastrointestinal recovery after open BR. A retrospective matched-cohort study (NCT01150760) was conducted using a national inpatient database. Each alvimopan patient was exact matched (surgical procedure, surgeon specialty) and propensity score matched (baseline characteristics) to a nonalvimopan BR patient. Outcomes included gastrointestinal and other morbidity (cardiovascular, pulmonary, infection, cerebrovascular, thromboembolic); mortality; readmission rate; and intensive care unit (ICU) stay (intent-to-treat [ITT] population). Postoperative LOS and estimated cost were also compared (modified ITT population). Each cohort included 3525 ITT patients with similar baseline characteristics. Gastrointestinal (29.8% vs 35.7%) and other morbidity (cardiovascular [19.4% vs 24.0%], pulmonary [7.3% vs 10.5%], infectious [9.6% vs 11.8%], thromboembolic [1.2% vs 2.1%]), mortality (0.4% vs 1.0%), and mean ICU stay (0.3 vs 0.6 days) were lower in the alvimopan group (P ≤ 0.003 for each). Postoperative LOS and estimated direct cost were lower for all alvimopan patients and after laparoscopic and open BR (LOS: -1.1, -0.8, and -1.8 days respectively; cost: -$2345, -$1382, and -$3218, respectively; P ≤ 0.0008 for each). On average, alvimopan-treated patients had a lower incidence of mortality and most incidents of morbidities. Length of stay, ICU use, and estimated cost were also lower with comparable readmissions. These results in patients outside the clinical trial setting include laparoscopic colectomy and demonstrate a potential association between acceleration of gastrointestinal recovery and improved early postoperative outcomes.

The Effect of Alvimopan on Recovery After Laparoscopic Segmental Colectomy

Alvimopan, a peripherally acting μ-opioid receptor antagonist, was recently approved for the reduction of postoperative ileus after open colectomy. No data are available regarding the use of alvimopan following laparoscopic segmental colectomy. This study was designed to evaluate the effectiveness of alvimopan in patients undergoing laparoscopic segmental colectomy. A retrospective review of segmental laparoscopic colectomy was conducted in a population of patients using an accelerated postcolectomy care pathway. Patients that received alvimopan were identified from an institutional review board-approved database and matched with nonalvimopan patients for age, sex, procedure, and diagnosis. Patients with a diverting ileostomy or with contraindications for alvimopam were excluded. One hundred patients undergoing laparoscopic colectomy received alvimopan perioperatively and were matched with a similar group of nonalvimopan patients. Although patients on alvimopan were significantly less likely to develop postoperative ileus (4% vs 12%; P = .04), there was no difference in length of hospital stay (3.63 days in the alvimopan group vs 3.78 in the nonalvimopan group; P = .84) or 30-day readmission rate (4.0% vs 4.2%; P = .95). As the cost of providing health care continues to increase, reductions in perioperative complications and hospital stay are important to hospital efficiency and patient care. Alvimopan effectively reduces the incidence of postoperative ileus in patients undergoing open colectomy; however, hospital stay and readmission rates were not altered in this laparoscopic group. Further study is required before alvimopan can be routinely used in patients undergoing laparoscopic colectomy.

Alvimopan Addition to a Standard Perioperative Recovery Pathway

Alvimopan, a peripherally acting mu-opioid receptor antagonist, decreased time to gastrointestinal recovery and hospital length of stay in open bowel resection patients in Phase 3 trials. However, the benefit in laparoscopic colectomy patients remains unclear. A retrospective case series review was performed to study addition of alvimopan to a well-established standard perioperative recovery pathway for elective laparoscopic colectomy. The main outcome measures were length of stay and incidence of charted postoperative ileus. Wilcoxon and chi-square tests were used to calculate P values for length of stay and postoperative ileus endpoints, respectively. Demographic/baseline characteristics from the 101 alvimopan and 64 pre-alvimopan control patients were generally comparable. Mean length of stay in the alvimopan group was 1.55 days shorter (alvimopan, 2.81±0.95 days; control, 4.36±2.4 days; P<.0001). The proportion of patients with postoperative ileus was lower in the alvimopan group (alvimopan, 2%; control, 20%; P<.0001). In this case series, addition of alvimopan to a standard perioperative recovery pathway decreased length of stay and incidence of postoperative ileus for elective uncomplicated laparoscopic colectomy. The improvement in the mean length of stay for patients who receive alvimopan is a step forward in achieving a fasttrack surgery model for elective laparoscopic colectomies.