PURPOSE: Postoperative ileus presents significant clinical challenges that potentially prolong hospital stay, contribute to readmission, and increase morbidity. There is no approved treatment for postoperative ileus. ...PURPOSE: Postoperative ileus presents significant clinical challenges that potentially prolong hospital stay, contribute to readmission, and increase morbidity. There is no approved treatment for postoperative ileus. Alvimopan is a novel, peripherally acting, mu opioid receptor antagonist currently in development for the management of postoperative ileus. METHODS: Patients undergoing partial colectomy or simple or radical hysterectomy were randomized to receive alvimopan 6 mg (n = 152), alvimopan 12 mg (n = 146), or placebo (n = 153) orally 2 hours before surgery and twice daily thereafter until discharge or for up to seven days. The primary efficacy end point, time to return of gastrointestinal function, was a composite measure of passage of flatus or stool and tolerating solid food. Secondary end points included time to the hospital discharge order written. Adverse events were monitored throughout the study. RESULTS: Mean time to gastrointestinal recovery was significantly reduced in patients treated with alvimopan 6 mg vs. placebo (hazard ratio = 1.45; P = 0.003), with a smaller reduction seen with alvimopan 12 mg (hazard ratio = 1.28; P = 0.059). Mean time to the hospital discharge order written was significantly accelerated in patients treated with alvimopan 6 mg (hazard ratio = 1.50; P < 0.001). The most common treatment-emergent adverse events across all treatment groups were nausea, vomiting, and hypotension; the incidence of nausea and vomiting was reduced by 53 percent in the alvimopan 12-mg group. CONCLUSIONS: In patients undergoing major abdominal surgery, alvimopan accelerated gastrointestinal recovery and time to the hospital discharge order written compared with placebo and was well tolerated.展开更多
PURPOSE: Conversion during laparoscopic colectomy varies in frequency according to the surgeon’s experience and case selection. However, there remains concern that conversion is associated with increased morbidity an...PURPOSE: Conversion during laparoscopic colectomy varies in frequency according to the surgeon’s experience and case selection. However, there remains concern that conversion is associated with increased morbidity and higher hospital costs. METHODS: From January 1999 to August 2002, 430 laparoscopic colectomies were performed by two surgeons, with 51 (12 percent) cases converted to open surgery. Converted cases were matched for operation and age to 51 open cases performed mostly by other colorectal surgeons from our department. Data collected included gender, American Society of Anesthesiology score, operative indication, resection type, operative stage at conversion, in hospital complications, direct hospital costs, unexpected readmission within 30 days, and mortality. RESULTS: There were no significant differences between the groups for age (converted, 55 ±19; open, 62 ±16), male:female ratio (converted, 17:34; open, 23:28), or American Society of Anesthesiology score distribution. Indications for surgery were neoplasia (converted, 16; open, 31); diverticular disease (converted, 21; open, 13); Crohn’s disease (converted, 12; open, 5); and other disease (converted, 2; open, 2). Operative times were similar (converted, 150 ±56 minutes; open, 132 ±48 minutes). Conversions occurred before defining the major vascular pedicle/ureter (50 percent), in relation to intracorporeal vascular ligation (15 percent), or during bowel transection or presacral dissection (35 percent). Specific indications for conversion were technical (41 percent), followed by adhesions (33 percent), phlegmon or abscess (23 percent), bleeding (6 percent), and failure to identify the ureter (6 percent). Median hospital stay was five days for both groups. In hospital complications (converted 11.6 percent; open 8 percent), 30 day readmission rate (converted 13 percent vs. open 8 percent), and direct costs were similar between groups. There were no mortalities. CONCLUSION: Conversion of a laparo scopic colectomy does not result in inappropriately prolonged operative times, increased morbidity or length of stay, increased direct costs, or unexpected readmissions compared with similarly complex laparotomies. A policy of commencing most cases suitable for a laparoscopic approach laparoscopically offers patients the benefits of a laparoscopic colectomy without adversely affecting perioperative risks.展开更多
PURPOSE: The Physiologic and Operative Severity Score for the enUmeration of M ortality and morbidity (POSSUM), Portsmouth revision (p)-POSSUM, and colorectal (Cr)-POSSUM scoring systems were developed as audit tools ...PURPOSE: The Physiologic and Operative Severity Score for the enUmeration of M ortality and morbidity (POSSUM), Portsmouth revision (p)-POSSUM, and colorectal (Cr)-POSSUM scoring systems were developed as audit tools for comparing outcomes in surgical and colorectal patients on the basis of operati ve risk assessment. The aim of this study was to evaluate the applicability of t hese systems to a cohort of colon cancer patients undergoing surgery in the Unit ed States. METHODS: POSSUM factors from 890 consecutive patients undergoing majo r surgical procedures for colon cancer in nine United States hospitals over a tw o-year period from January 2000 through December 2001 were prospectively collec ted. The observed over the expected hospital mortality was compared by means of the POSSUM, p-POSSUM, and Cr-POSSUM scoring systems. The effect of missing dat a on the utility of this process for outcome assessment was assessed with three methods for data imputation. RESULTS: The number of resections per institution r anged from 13 to 437. The observed mortality rate ranged from 0.8 percent to 15. 4 percent among the institutions, with an overall operative mortality of 2.3 per cent. The POSSUM, p-POSSUM, and Cr-POSSUM predicted mortality was 10.7 percent , 11.2 percent, and 4.9 percent, respectively. The POSSUM and p-POSSUM models o verpredicted mortality in all institutions (P < 0.01), whereas the Cr-POSSUM de monstrated an observed over expected hospital mortality ratio of >1 in three ins titutions. The calculations were unaffected by the various methods of inserting missing data. CONCLUSION: An apparent overprediction of mortality for colon canc er resection was evident with all three POSSUM variants. This implies that a cal ibration process is required for use of these variants in the United States heal th care system. Missing data may be treated as normal values without influencing outcome. The Cr-POSSUM appeared to be the most promising audit tool for colore ctal cancer surgery; however, it will require further refinement to provide proc ess control graphs for identification of potential outliers and improvement in t he quality of care in the United States.展开更多
文摘PURPOSE: Postoperative ileus presents significant clinical challenges that potentially prolong hospital stay, contribute to readmission, and increase morbidity. There is no approved treatment for postoperative ileus. Alvimopan is a novel, peripherally acting, mu opioid receptor antagonist currently in development for the management of postoperative ileus. METHODS: Patients undergoing partial colectomy or simple or radical hysterectomy were randomized to receive alvimopan 6 mg (n = 152), alvimopan 12 mg (n = 146), or placebo (n = 153) orally 2 hours before surgery and twice daily thereafter until discharge or for up to seven days. The primary efficacy end point, time to return of gastrointestinal function, was a composite measure of passage of flatus or stool and tolerating solid food. Secondary end points included time to the hospital discharge order written. Adverse events were monitored throughout the study. RESULTS: Mean time to gastrointestinal recovery was significantly reduced in patients treated with alvimopan 6 mg vs. placebo (hazard ratio = 1.45; P = 0.003), with a smaller reduction seen with alvimopan 12 mg (hazard ratio = 1.28; P = 0.059). Mean time to the hospital discharge order written was significantly accelerated in patients treated with alvimopan 6 mg (hazard ratio = 1.50; P < 0.001). The most common treatment-emergent adverse events across all treatment groups were nausea, vomiting, and hypotension; the incidence of nausea and vomiting was reduced by 53 percent in the alvimopan 12-mg group. CONCLUSIONS: In patients undergoing major abdominal surgery, alvimopan accelerated gastrointestinal recovery and time to the hospital discharge order written compared with placebo and was well tolerated.
文摘PURPOSE: Conversion during laparoscopic colectomy varies in frequency according to the surgeon’s experience and case selection. However, there remains concern that conversion is associated with increased morbidity and higher hospital costs. METHODS: From January 1999 to August 2002, 430 laparoscopic colectomies were performed by two surgeons, with 51 (12 percent) cases converted to open surgery. Converted cases were matched for operation and age to 51 open cases performed mostly by other colorectal surgeons from our department. Data collected included gender, American Society of Anesthesiology score, operative indication, resection type, operative stage at conversion, in hospital complications, direct hospital costs, unexpected readmission within 30 days, and mortality. RESULTS: There were no significant differences between the groups for age (converted, 55 ±19; open, 62 ±16), male:female ratio (converted, 17:34; open, 23:28), or American Society of Anesthesiology score distribution. Indications for surgery were neoplasia (converted, 16; open, 31); diverticular disease (converted, 21; open, 13); Crohn’s disease (converted, 12; open, 5); and other disease (converted, 2; open, 2). Operative times were similar (converted, 150 ±56 minutes; open, 132 ±48 minutes). Conversions occurred before defining the major vascular pedicle/ureter (50 percent), in relation to intracorporeal vascular ligation (15 percent), or during bowel transection or presacral dissection (35 percent). Specific indications for conversion were technical (41 percent), followed by adhesions (33 percent), phlegmon or abscess (23 percent), bleeding (6 percent), and failure to identify the ureter (6 percent). Median hospital stay was five days for both groups. In hospital complications (converted 11.6 percent; open 8 percent), 30 day readmission rate (converted 13 percent vs. open 8 percent), and direct costs were similar between groups. There were no mortalities. CONCLUSION: Conversion of a laparo scopic colectomy does not result in inappropriately prolonged operative times, increased morbidity or length of stay, increased direct costs, or unexpected readmissions compared with similarly complex laparotomies. A policy of commencing most cases suitable for a laparoscopic approach laparoscopically offers patients the benefits of a laparoscopic colectomy without adversely affecting perioperative risks.
文摘PURPOSE: The Physiologic and Operative Severity Score for the enUmeration of M ortality and morbidity (POSSUM), Portsmouth revision (p)-POSSUM, and colorectal (Cr)-POSSUM scoring systems were developed as audit tools for comparing outcomes in surgical and colorectal patients on the basis of operati ve risk assessment. The aim of this study was to evaluate the applicability of t hese systems to a cohort of colon cancer patients undergoing surgery in the Unit ed States. METHODS: POSSUM factors from 890 consecutive patients undergoing majo r surgical procedures for colon cancer in nine United States hospitals over a tw o-year period from January 2000 through December 2001 were prospectively collec ted. The observed over the expected hospital mortality was compared by means of the POSSUM, p-POSSUM, and Cr-POSSUM scoring systems. The effect of missing dat a on the utility of this process for outcome assessment was assessed with three methods for data imputation. RESULTS: The number of resections per institution r anged from 13 to 437. The observed mortality rate ranged from 0.8 percent to 15. 4 percent among the institutions, with an overall operative mortality of 2.3 per cent. The POSSUM, p-POSSUM, and Cr-POSSUM predicted mortality was 10.7 percent , 11.2 percent, and 4.9 percent, respectively. The POSSUM and p-POSSUM models o verpredicted mortality in all institutions (P < 0.01), whereas the Cr-POSSUM de monstrated an observed over expected hospital mortality ratio of >1 in three ins titutions. The calculations were unaffected by the various methods of inserting missing data. CONCLUSION: An apparent overprediction of mortality for colon canc er resection was evident with all three POSSUM variants. This implies that a cal ibration process is required for use of these variants in the United States heal th care system. Missing data may be treated as normal values without influencing outcome. The Cr-POSSUM appeared to be the most promising audit tool for colore ctal cancer surgery; however, it will require further refinement to provide proc ess control graphs for identification of potential outliers and improvement in t he quality of care in the United States.
