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Conor P Delaney - One of the best experts on this subject based on the ideXlab platform.
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evaluation of healthcare use and clinical outcomes of alvimopan in patients undergoing Bowel Resection a propensity score matched analysis
Diseases of The Colon & Rectum, 2018Co-Authors: Scott R Steele, Justin T Brady, Zhun Cao, Dorothy Baumer, Scott B Robinson, Keri H Yang, Conor P DelaneyAbstract:BACKGROUND Postoperative ileus is a significant complication after Bowel Resection surgeries. Alvimopan is the only US Food and Drug Administration-approved therapy for accelerating the return of Bowel function after large- and small-Bowel Resection. OBJECTIVE The purpose of this study was to estimate the healthcare use and in-hospital morbidities associated with on-label use of alvimopan in patients undergoing Bowel Resection surgeries. DESIGN A retrospective observational propensity-matched cohort study was conducted using a large hospital administrative database. SETTING The study included inpatient postsurgical patients. PATIENTS Patients aged ≥18 years undergoing a primary large or small segmental Bowel Resection with discharge dates between January 2010 and December 2014 were included. INTERVENTIONS Patients receiving 2 to 15 doses of alvimopan were defined as the treatment cohort, and those without any alvimopan use were included as control subjects. MAIN OUTCOME MEASURES The primary outcome was postoperative length of stay. Secondary outcomes included postoperative in-hospital morbidities, inpatient mortality, intensive care unit length of stay, discharge disposition, and 30-day readmission. RESULTS Each propensity-score matched cohort included 18,559 patients. The mean (±SD) postoperative length of stay was 4.62 ± 2.45 days in alvimopan-treated patients compared with 5.24 ± 3.35 days in control subjects (p < 0.001). Alvimopan-treated patients had lower rates of postoperative GI complication (12.15% vs 16.50%; p < 0.001). The rates of urinary tract infections; other postoperative infections; and cardiovascular, pulmonary, thromboembolic, and cerebrovascular events were also lower compared with the control subjects. LIMITATIONS The study was limited by its inability to generalize to the US population, because the database included a convenience sample of hospital discharges. The identification of patients undergoing Bowel Resection and their clinical conditions relied on the accuracy and completeness of International Classification of Diseases, Ninth Revision, Clinical Modification diagnosis and procedure coding. There may be a confounding effect by the use of enhanced recovery pathways associated with the use of alvimopan. CONCLUSIONS The use of alvimopan was associated with a reduction of 0.62 days in postsurgery length of stay and lower rates of postoperative GI complications, infections, and other in-hospital morbidities. See Video Abstract at http://links.lww.com/DCR/A703.
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31 laparoscopic ileocecectomy small Bowel Resection and strictureplasty for crohn s disease
2012Co-Authors: Joanne Favuzza, Conor P DelaneyAbstract:Crohn’s disease is a chronic inflammatory Bowel disease that can affect the entire digestive tract, most often the terminal ileum. The treatment of Crohn’s disease consists of medical management primarily with the use of steroids and immunomodulating agents. Despite medical therapy, 80% of patients will require surgical intervention during their lifetime. The most common surgery performed for Crohn’s patients is an ileocolic Resection for stricture or obstruction. This chapter provides a step-by-step approach to performing laparoscopic-assisted ileocecectomy, strictureplasty, and small Bowel Resection. The benefits of laparoscopic surgery for Crohn’s patients include decreased length of stay, reduced morbidity as well as improved cosmesis.
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alvimopan for the management of postoperative ileus after Bowel Resection characterization of clinical benefit by pooled responder analysis
World Journal of Surgery, 2010Co-Authors: Kirk A Ludwig, Bruce G Wolff, Conor P Delaney, Anthony J Senagore, Eugene R. Viscusi, Lee TechnerAbstract:Background A pooled post hoc responder analysis was performed to assess the clinical benefit of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, for the management of postoperative ileus after Bowel Resection.
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gastrointestinal tract recovery in patients undergoing Bowel Resection results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway
Archives of Surgery, 2008Co-Authors: John G Fort, Maryann Cherubini, James Cucinotta, Warren E Enker, Kirk A Ludwig, Bruce G Wolff, Conor P Delaney, Wei Du, Lee TechnerAbstract: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 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
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postoperative ileus related morbidity profile in patients treated with alvimopan after Bowel Resection
Journal of The American College of Surgeons, 2007Co-Authors: Bruce G Wolff, Kirk A Ludwig, Conor P Delaney, James L. Weese, Michael J Stamos, Fabrizio Michelassi, Lee TechnerAbstract:Background Postoperative ileus (POI), an interruption of coordinated Bowel motility after operation, is exacerbated by opioids used to manage pain. Alvimopan, a peripherally acting μ-opioid receptor antagonist, accelerated gastrointestinal (GI) recovery after Bowel Resection in randomized, double-blind, placebo-controlled, multicenter phase III POI trials. The effect of alvimopan on POI-related morbidity for patients who underwent Bowel Resection was evaluated in a post-hoc analysis. Study Design Incidence of POI-related postoperative morbidity (postoperative nasogastric tube insertion or POI-related prolonged hospital stay or readmission) was analyzed in four North American trials for placebo or alvimopan 12 mg administered 30 minutes or more preoperatively and twice daily postoperatively until hospital discharge (7 or fewer postoperative days). GI-related adverse events and opioid consumption were summarized for each treatment. Estimations of odds ratios of alvimopan to placebo and number needed to treat (NNT) to prevent one patient from experiencing an event of POI-related morbidity were derived from the analysis. Results Patients receiving alvimopan 12 mg were less likely to experience POI-related morbidity than patients receiving placebo (odds ratio=0.44, p Conclusions Alvimopan 12 mg was associated with reduced POI-related morbidity compared with placebo, without compromising opioid-based analgesia in patients undergoing Bowel Resection. Relatively low NNTs are clinically meaningful and reinforce the potential benefits of alvimopan for the patient and health care system.
Lee Techner - One of the best experts on this subject based on the ideXlab platform.
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impact of alvimopan entereg on hospital costs after Bowel Resection results from a large inpatient database
P & T : a peer-reviewed journal for formulary management, 2011Co-Authors: Sara Poston, Michael S Broder, Melinda Maggard Gibbons, Robert Maclaren, Eunice Chang, Christine J Vandepol, Suzanne F Cook, Lee TechnerAbstract:Purpose: Delayed gastrointestinal (GI) recovery after Bowel Resection is associated with longer hospital stays and increased health care costs. Alvimopan (Entereg), a peripherally acting mu-opioid receptor antagonist, accelerates GI recovery after Bowel-Resection surgery. We undertook a study to evaluate the economic impact of alvimopan in clinical practice. Methods: We conducted a retrospective matched cohort study using data from a large national hospital database and identified adults who had undergone small-Bowel or largeBowel Resection with primary anastomosis. The patients were discharged between January 1, 2009, and June 30, 2009. The surgery was performed at a hospital where alvimopan was used at least once during the study period. We matched each alvimopan patient (“user”) with two controls (“non-users”). The primary outcome of total hospital costs (including the cost of alvimopan) and secondary outcomes of cost components and length of stay were compared between groups. Results: The final study cohort included 480 alvimopan patients and 960 matched controls. The mean total hospital cost was $12,865 for alvimopan patients, compared with $13,905 for controls, for a difference of $1,040 (P = 0.033). There was a nonsignificant trend toward lower ileus-related costs between groups ($83 for alvimopan vs. $114 for controls, P = 0.086). Pharmacy and diagnostic radiology costs did not differ significantly. The mean length of stay was 5.6 days for alvimopan patients and 6.5 days for controls (P < 0.001). Conclusion: Patients receiving alvimopan capsules had significantly lower total hospital costs compared with controls. Along with other initiatives to improve quality and reduce costs of surgical care, alvimopan might be a good choice for
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alvimopan for the management of postoperative ileus after Bowel Resection characterization of clinical benefit by pooled responder analysis
World Journal of Surgery, 2010Co-Authors: Kirk A Ludwig, Bruce G Wolff, Conor P Delaney, Anthony J Senagore, Eugene R. Viscusi, Lee TechnerAbstract:Background A pooled post hoc responder analysis was performed to assess the clinical benefit of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, for the management of postoperative ileus after Bowel Resection.
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gastrointestinal tract recovery in patients undergoing Bowel Resection results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway
Archives of Surgery, 2008Co-Authors: John G Fort, Maryann Cherubini, James Cucinotta, Warren E Enker, Kirk A Ludwig, Bruce G Wolff, Conor P Delaney, Wei Du, Lee TechnerAbstract: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 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
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alvimopan accelerates gastrointestinal recovery after Bowel Resection regardless of age gender race or concomitant medication use
Surgery, 2007Co-Authors: Anthony J Senagore, Joel J Bauer, Lee TechnerAbstract:Background Postoperative ileus is a transient cessation of Bowel motility that occurs after Bowel Resection (BR). Alvimopan, a peripherally acting μ-opioid receptor antagonist accelerated gastrointestinal (GI) recovery in 5 randomized, double-blind, phase III postoperative ileus trials. Methods Individual covariates (age, gender, race) were assessed separately using Cox proportional hazards models that included the main effects of treatment and covariate factor. Time-to-GI recovery (GI-3 [first toleration of solid food and first Bowel movement or flatus]; GI-2 [first toleration of solid food and first Bowel movement]) for patients who underwent open laparotomy for BR in the absence of epidural anesthesia and received alvimopan (12 mg) or placebo was analyzed within subgroups (age, gender, race, concomitant medication use) using Cox proportional hazards models to generate hazard ratios (HRs). P values were calculated with the Wald χ2 test. Results Elderly (≥65 years), male, and nonwhite patients achieved GI-3 recovery later than younger ( 1 and P 1 and P Conclusions These post hoc analyses support that alvimopan (12 mg) accelerates GI recovery across various patient populations.
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postoperative ileus related morbidity profile in patients treated with alvimopan after Bowel Resection
Journal of The American College of Surgeons, 2007Co-Authors: Bruce G Wolff, Kirk A Ludwig, Conor P Delaney, James L. Weese, Michael J Stamos, Fabrizio Michelassi, Lee TechnerAbstract:Background Postoperative ileus (POI), an interruption of coordinated Bowel motility after operation, is exacerbated by opioids used to manage pain. Alvimopan, a peripherally acting μ-opioid receptor antagonist, accelerated gastrointestinal (GI) recovery after Bowel Resection in randomized, double-blind, placebo-controlled, multicenter phase III POI trials. The effect of alvimopan on POI-related morbidity for patients who underwent Bowel Resection was evaluated in a post-hoc analysis. Study Design Incidence of POI-related postoperative morbidity (postoperative nasogastric tube insertion or POI-related prolonged hospital stay or readmission) was analyzed in four North American trials for placebo or alvimopan 12 mg administered 30 minutes or more preoperatively and twice daily postoperatively until hospital discharge (7 or fewer postoperative days). GI-related adverse events and opioid consumption were summarized for each treatment. Estimations of odds ratios of alvimopan to placebo and number needed to treat (NNT) to prevent one patient from experiencing an event of POI-related morbidity were derived from the analysis. Results Patients receiving alvimopan 12 mg were less likely to experience POI-related morbidity than patients receiving placebo (odds ratio=0.44, p Conclusions Alvimopan 12 mg was associated with reduced POI-related morbidity compared with placebo, without compromising opioid-based analgesia in patients undergoing Bowel Resection. Relatively low NNTs are clinically meaningful and reinforce the potential benefits of alvimopan for the patient and health care system.
Anthony J Senagore - One of the best experts on this subject based on the ideXlab platform.
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alvimopan for the management of postoperative ileus after Bowel Resection characterization of clinical benefit by pooled responder analysis
World Journal of Surgery, 2010Co-Authors: Kirk A Ludwig, Bruce G Wolff, Conor P Delaney, Anthony J Senagore, Eugene R. Viscusi, Lee TechnerAbstract:Background A pooled post hoc responder analysis was performed to assess the clinical benefit of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, for the management of postoperative ileus after Bowel Resection.
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alvimopan accelerates gastrointestinal recovery after Bowel Resection regardless of age gender race or concomitant medication use
Surgery, 2007Co-Authors: Anthony J Senagore, Joel J Bauer, Lee TechnerAbstract:Background Postoperative ileus is a transient cessation of Bowel motility that occurs after Bowel Resection (BR). Alvimopan, a peripherally acting μ-opioid receptor antagonist accelerated gastrointestinal (GI) recovery in 5 randomized, double-blind, phase III postoperative ileus trials. Methods Individual covariates (age, gender, race) were assessed separately using Cox proportional hazards models that included the main effects of treatment and covariate factor. Time-to-GI recovery (GI-3 [first toleration of solid food and first Bowel movement or flatus]; GI-2 [first toleration of solid food and first Bowel movement]) for patients who underwent open laparotomy for BR in the absence of epidural anesthesia and received alvimopan (12 mg) or placebo was analyzed within subgroups (age, gender, race, concomitant medication use) using Cox proportional hazards models to generate hazard ratios (HRs). P values were calculated with the Wald χ2 test. Results Elderly (≥65 years), male, and nonwhite patients achieved GI-3 recovery later than younger ( 1 and P 1 and P Conclusions These post hoc analyses support that alvimopan (12 mg) accelerates GI recovery across various patient populations.
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alvimopan for postoperative ileus following Bowel Resection a pooled analysis of phase iii studies
Annals of Surgery, 2007Co-Authors: Conor P Delaney, John G Fort, Lee Techner, Bruce G Wolff, Anthony J Senagore, Eugene R. Viscusi, Bruce WallinAbstract:In the United States, nearly 350,000 patients undergo colorectal or small Bowel Resection (BR) annually.1 These patients spend an average of 11 days in the hospital and account for >$15 billion in annual national healthcare costs.1 All of these patients experience postoperative ileus (POI), a temporary impairment of gastrointestinal (GI) function.2–4 Moreover, associated GI complications are common.5 For patients who undergo BR, length of hospital stay (LOS) is dictated mostly by timing of GI recovery. To facilitate GI recovery, some specialized centers have used accelerated care pathways, although readmission rates have been increased in some cases.6–10 Reducing surgical complications and further accelerating GI recovery after BR could increase patient comfort, decrease the average LOS, and reduce costs, readmission rates, and other demands on healthcare resources.11 The etiology of POI is complex, and major intrinsic contributing factors include surgical stress (ie, from physical manipulation of the Bowel), secretion of inflammatory mediators and endogenous opioids in the GI tract, and changes in hormone levels and electrolyte and fluid balance.12–15 Opioids are the most widely prescribed analgesics used to treat postoperative pain.16 However, opioids bind to mu-opioid receptors within the gut, exacerbating POI.12,14 No specific treatment currently exists for the treatment or prevention of POI. Alvimopan is a novel, oral, peripherally acting, mu-opioid receptor (PAM-OR) antagonist that has been studied in patients undergoing abdominal and pelvic surgery.17–19 In 3 phase III multicenter trials, alvimopan accelerated GI recovery after BR or total abdominal hysterectomy (TAH).17–19 Although the results favored alvimopan across studies, statistical significance and magnitude of treatment effect were not consistent with regard to the primary endpoint, a composite assessment that included toleration of solid food and first passage of flatus or stool (GI-3). Further, the individual studies were not powered sufficiently to investigate infrequent but clinically important postoperative morbidities or investigate potential differences between the 6- and 12-mg doses. Hence, a pooled analysis was performed to examine the safety and efficacy of alvimopan within the subgroup of patients who underwent BR.
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does means of access affect the incidence of small Bowel obstruction and ventral hernia after Bowel Resection laparoscopy versus laparotomy
Journal of The American College of Surgeons, 2003Co-Authors: Hans J Duepree, Conor P Delaney, Anthony J Senagore, Victor W FazioAbstract:Abstract Background Laparotomy for Bowel Resection is causally related to the development of small Bowel obstruction (SBO) and ventral hernia, with incidences approaching 12% to 15% each. This report attempts to define the incidence of these access-related complications in a large group of patients undergoing laparoscopic-assisted Bowel Resection (LABR) and open Bowel operation (OPEN). Study design A retrospective cohort of 716 consecutive patients undergoing either LABR (n = 211) or OPEN (n = 505) procedures between January 1995 and July 2000 was identified and selected from a prospective registry. Results Index LABR (n = 211) and OPEN (n = 505) cases included segmental colectomy in 146 LABR and 408 OPEN patients; subtotal colectomy with or without stoma in 18 LABR and 6 OPEN patients; ileocolectomy in 37 LABR and 85 OPEN patients; and small Bowel Resection in 10 LABR and 6 OPEN patients. The mean followup periods in the LABR and OPEN groups were 2.71 years and 2.42 years, respectively. The incidence of wound hernia was significantly higher in OPEN cases (n = 65) compared with LABR (n = 5) (p Conclusions The data demonstrate that laparoscopic access for Bowel operation significantly reduces the incidence of ventral hernia and SBO rates compared with laparotomy. This reduces the need for readmission to the hospital and additional surgical procedures, providing a potential source of decreased morbidity. It should be considered as a means of cost savings associated with laparoscopic Bowel operations.
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does means of access affect the incidence of small Bowel obstruction and ventral hernia after Bowel Resection laparoscopy versus laparotomy
Journal of The American College of Surgeons, 2003Co-Authors: Hans J Duepree, Conor P Delaney, Anthony J Senagore, Victor W FazioAbstract:BACKGROUND: Laparotomy for Bowel Resection is causally related to the development of small Bowel obstruction (SBO) and ventral hernia, with incidences approaching 12% to 15% each. This report attempts to define the incidence of these access-related complications in a large group of patients undergoing laparoscopic-assisted Bowel Resection (LABR) and open Bowel operation (OPEN). STUDY DESIGN: A retrospective cohort of 716 consecutive patients undergoing either LABR (n = 211) or OPEN (n = 505) procedures between January 1995 and July 2000 was identified and selected from a prospective registry. RESULTS: Index LABR (n = 211) and OPEN (n = 505) cases included segmental colectomy in 146 LABR and 408 OPEN patients; subtotal colectomy with or without stoma in 18 LABR and 6 OPEN patients; ileocolectomy in 37 LABR and 85 OPEN patients; and small Bowel Resection in 10 LABR and 6 OPEN patients. The mean followup periods in the LABR and OPEN groups were 2.71 years and 2.42 years, respectively. The incidence of wound hernia was significantly higher in OPEN cases (n = 65) compared with LABR (n = 5) (p < 0.05). The incidence of surgical repair of ventral hernia was also significantly higher in the OPEN group (28) compared with LABR (4) (p < 0.05). Postoperative SBO requiring hospitalization with conservative management occurred significantly less frequently in LABR patients (n = 4) compared with OPEN patients (n = 31) (p = 0.016). The need for surgical release of SBO was similar between the OPEN and LABR groups (n = 4 versus n = 11). The overall reoperation rate for these two complications was two times higher in the OPEN group than in the LABR group (7.7% versus 3.8%). CONCLUSIONS: The data demonstrate that laparoscopic access for Bowel operation significantly reduces the incidence of ventral hernia and SBO rates compared with laparotomy. This reduces the need for readmission to the hospital and additional surgical procedures, providing a potential source of decreased morbidity. It should be considered as a means of cost savings associated with laparoscopic Bowel operations.
Liane S Feldman - One of the best experts on this subject based on the ideXlab platform.
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impact of adherence to care pathway interventions on recovery following Bowel Resection within an established enhanced recovery program
Surgical Endoscopy and Other Interventional Techniques, 2017Co-Authors: Nicolò Pecorelli, Julio F. Fiore, Olivia Hershorn, Patrick Charlebois, Barry Stein, Franco Carli, Gabriele Baldini, Sender A Liberman, Liane S FeldmanAbstract:Introduction Guidelines recommend incorporation of more than 20 perioperative interventions within an enhanced recovery program (ERP). However, the impact of overall adherence to the pathway and the relative contribution of each intervention are unclear. The aim of this study was to estimate the extent to which adherence to ERP elements is associated with outcomes and identify key ERP elements predicting successful recovery following Bowel Resection.
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impact of adherence to care pathway interventions on recovery following Bowel Resection within an established enhanced recovery program
Surgical Endoscopy and Other Interventional Techniques, 2017Co-Authors: Nicolò Pecorelli, Julio F. Fiore, Olivia Hershorn, Patrick Charlebois, Barry Stein, Franco Carli, Gabriele Baldini, Sender A Liberman, Liane S FeldmanAbstract:Guidelines recommend incorporation of more than 20 perioperative interventions within an enhanced recovery program (ERP). However, the impact of overall adherence to the pathway and the relative contribution of each intervention are unclear. The aim of this study was to estimate the extent to which adherence to ERP elements is associated with outcomes and identify key ERP elements predicting successful recovery following Bowel Resection. Prospectively collected data entered in a registry specifically designed for ERPs were reviewed. Patients undergoing elective Bowel Resection between 2012 and 2014 were treated within an ERP comprising 23 care elements. Primary outcome was successful recovery defined as the absence of complications, discharge by postoperative day 4 and no readmission. Secondary outcomes were length of hospital stay (LOS), 30-day morbidity, and severity (Comprehensive complication index, CCI, 0–100). Regression analyses were adjusted for potential confounders. A total of 347 patients were included in the study. Median primary LOS was 4 days (IQR 3–7). Patients were adherent to median 18 (IQR 16–20) elements. A total of 156 (45 %) patients had successful recovery. Morbidity occurred in 175 (50 %) patients with median CCI 8.6 (IQR 0–22.6). There was a positive association between adherence and successful recovery (OR 1.39 for every additional element, p < 0.001), LOS (11 % reduction for every additional element, p < 0.001), 30-day postoperative morbidity (OR 0.78, p < 0.001), and the CCI (17 % reduction, p < 0.001). Laparoscopy (OR 4.32, p < 0.001), early mobilization out of bed (OR 2.25, p = 0.021), and early termination of IV fluid infusion (OR 2.00, p = 0.013) significantly predicted successful recovery. These factors were also associated with reduced morbidity and complication severity. Increased adherence to ERP interventions was associated with successful early recovery and a reduction in postoperative morbidity and complication severity. In an established ERP where overall adherence was high, laparoscopic approach, perioperative fluid management, and patient mobilization remain key elements associated with improved outcomes.
Kirk A Ludwig - One of the best experts on this subject based on the ideXlab platform.
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alvimopan for the management of postoperative ileus after Bowel Resection characterization of clinical benefit by pooled responder analysis
World Journal of Surgery, 2010Co-Authors: Kirk A Ludwig, Bruce G Wolff, Conor P Delaney, Anthony J Senagore, Eugene R. Viscusi, Lee TechnerAbstract:Background A pooled post hoc responder analysis was performed to assess the clinical benefit of alvimopan, a peripherally acting mu-opioid receptor (PAM-OR) antagonist, for the management of postoperative ileus after Bowel Resection.
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gastrointestinal tract recovery in patients undergoing Bowel Resection results of a randomized trial of alvimopan and placebo with a standardized accelerated postoperative care pathway
Archives of Surgery, 2008Co-Authors: John G Fort, Maryann Cherubini, James Cucinotta, Warren E Enker, Kirk A Ludwig, Bruce G Wolff, Conor P Delaney, Wei Du, Lee TechnerAbstract: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 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
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postoperative ileus related morbidity profile in patients treated with alvimopan after Bowel Resection
Journal of The American College of Surgeons, 2007Co-Authors: Bruce G Wolff, Kirk A Ludwig, Conor P Delaney, James L. Weese, Michael J Stamos, Fabrizio Michelassi, Lee TechnerAbstract:Background Postoperative ileus (POI), an interruption of coordinated Bowel motility after operation, is exacerbated by opioids used to manage pain. Alvimopan, a peripherally acting μ-opioid receptor antagonist, accelerated gastrointestinal (GI) recovery after Bowel Resection in randomized, double-blind, placebo-controlled, multicenter phase III POI trials. The effect of alvimopan on POI-related morbidity for patients who underwent Bowel Resection was evaluated in a post-hoc analysis. Study Design Incidence of POI-related postoperative morbidity (postoperative nasogastric tube insertion or POI-related prolonged hospital stay or readmission) was analyzed in four North American trials for placebo or alvimopan 12 mg administered 30 minutes or more preoperatively and twice daily postoperatively until hospital discharge (7 or fewer postoperative days). GI-related adverse events and opioid consumption were summarized for each treatment. Estimations of odds ratios of alvimopan to placebo and number needed to treat (NNT) to prevent one patient from experiencing an event of POI-related morbidity were derived from the analysis. Results Patients receiving alvimopan 12 mg were less likely to experience POI-related morbidity than patients receiving placebo (odds ratio=0.44, p Conclusions Alvimopan 12 mg was associated with reduced POI-related morbidity compared with placebo, without compromising opioid-based analgesia in patients undergoing Bowel Resection. Relatively low NNTs are clinically meaningful and reinforce the potential benefits of alvimopan for the patient and health care system.