Anthony J. Senagore

Prospective, randomized, controlled trial between a pathway of controlled rehabilitation with early ambulation and diet and traditional postoperative care after laparotomy and intestinal resection.

AbstractINTRODUCTION: In an era of dwindling hospital resources and increasing medical costs, safe reduction in postoperative stay has become a major focus to optimize utilization of healthcare resources. Although several protocols have been reported to reduce postoperative stay, no Level I evidence exists for their use in routine clinical practice. METHODS: Sixty-four patients undergoing laparotomy and intestinal or rectal resection were randomly assigned to a pathway of controlled rehabilitation with early ambulation and diet or to traditional postoperative care. Time to discharge from hospital, complication and readmission rates, pain level, quality of life, and patient satisfaction scores were determined at the time of discharge and at 10 and 30 days after surgery. Subgroups were defined to evaluate those who derived the optimal benefit from the protocol. RESULTS: Pathway patients spent less total time in the hospital after surgery (5.4 vs. 7.1 days; P = 0.02) and less time in the hospital during the primary admission than traditional patients. Patients younger than 70 years old had greater benefits than the overall study group (5 vs. 7.1 days; P = 0.01). Patients treated by surgeons with the most experience with the pathway spent significantly less time in the hospital than did those whose surgeons were less experienced with the pathway (P = 0.01). There was no difference between pathway and traditional patients for readmission or complication rates, pain score, quality of life after surgery, or overall satisfaction with the hospital stay. CONCLUSIONS: Patients scheduled for a laparotomy and major intestinal or rectal resection are suitable for management by a pathway of controlled rehabilitation with early ambulation and diet. Pathway patients have a shorter hospital stay, with no adverse effect on patient satisfaction, pain scores, or complication rates. Patients younger than 70 years of age derive the optimal benefit, and increased surgeon experience improves outcome.

Enhanced recovery pathways optimize health outcomes and resource utilization: a meta-analysis of randomized controlled trials in colorectal surgery

BACKGROUND Health care systems provide care to increasingly complex and elderly patients. Colorectal surgery is a prime example, with high volumes of major procedures, significant morbidity, prolonged hospital stays, and unplanned readmissions. This situation is exacerbated by an exponential rise in costs that threatens the stability of health care systems. Enhanced recovery pathways (ERP) have been proposed as a means to reduce morbidity and improve effectiveness of care. We have reviewed the evidence supporting the implementation of ERP in clinical practice. METHODS Medline, Embase, and the Cochrane library were searched for randomized, controlled trials comparing ERP with traditional care in colorectal surgery. Systematic reviews and papers on ERP based on data published in major surgical and anesthesiology journals were critically reviewed by international contributors, experienced in the development and implementation of ERP. RESULTS A random-effect Bayesian meta-analysis was performed, including 6 randomized, controlled trials totalizing 452 patients. For patients adhering to ERP, length of stay decreased by 2.5 days (95% credible interval [CrI] -3.92 to -1.11), whereas 30-day morbidity was halved (relative risk, 0.52; 95% CrI, 0.36-0.73) and readmission was not increased (relative risk, 0.59; 95% CrI, 0.14-1.43) when compared with patients undergoing traditional care. CONCLUSION Adherence to ERP achieves a reproducible improvement in the quality of care by enabling standardization of health care processes. Thus, while accelerating recovery and safely reducing hospital stay, ERPs optimize utilization of health care resources. ERPs can and should be routinely used in care after colorectal and other major gastrointestinal procedures.

Early results of laparoscopic surgery for colorectal cancer - Retrospective analysis of 372 patients treated by clinical outcomes of Surgical Therapy (Cost) Study Group

PURPOSE: This study was undertaken to determine the early experience of the embers of the COST Study Group with colorectal cancer treated by laparoscopic approaches. METHOD: A retrospective review was performed of all patients with colorectal cancer treated with laparoscopy by the COST Study Group before August 1994. Tumor site, stage, differentiation, procedure completion, presence of recurrence (local, distant, trocar site), and cause of death were analyzed. RESULTS: A total of 372 patients with adenocarcinoma of the colon and rectum were treated by laparoscopic approach between October 1991 and August 1994 (170 men and 192 women): right colectomy, 170; sigmoid colectomy, 55; low anterior resection, 56; abdominoperineal resection, 44; left colectomy, 22; colostomy, 8; total colectomy, 6; transverse colectomy, 7; exploration, 2. Conversion to an open procedure was required in 15.6 percent of cases. Operative mortality was 2 percent. Tumor characteristics were as follows: TNM state: I, 40 percent; II, 25 percent; III, 18 percent; IV, 17 percent; Differentiation: well-moderate, 88 percent; poor, 12 percent; carcinomatosis, 5 percent. Local (3.6 percent) and distant implantation occurred in four patients (1.1 percent). Only one of these patients died a cancer-related death (Stage III at 36 months). Cancer-related death rates increased with increasing stage of tumor: I, −4 percent; II, 17 percent; III, 31 percent; IV, 70 percent. CONCLUSION: A laparoscopic approach to colorectal cancer results in early outcome after treatment that is comparable with conventional therapy for colorectal cancer. A randomized trial is needed to compare long-term outcomes of open and laparoscopic approaches with colorectal cancer.

Renal biomarker qualification submission: a dialog between the FDA-EMEA and Predictive Safety Testing Consortium

The first formal qualification of safety biomarkers for regulatory decision making marks a milestone in the application of biomarkers to drug development. Following submission of drug toxicity studies and analyses of biomarker performance to the Food and Drug Administration (FDA) and European Medicines Agency (EMEA) by the Predictive Safety Testing Consortiums (PSTC) Nephrotoxicity Working Group, seven renal safety biomarkers have been qualified for limited use in nonclinical and clinical drug development to help guide safety assessments. This was a pilot process, and the experience gained will both facilitate better understanding of how the qualification process will probably evolve and clarify the minimal requirements necessary to evaluate the performance of biomarkers of organ injury within specific contexts.

Comparison of Robotically Performed and Traditional Laparoscopic Colorectal Surgery

Robotic laparoscopic surgery is postulated to result in better surgical results by allowing improved instrument manipulation and three-dimensional vision. The authors’ experience performing robot-assisted laparoscopic colorectal surgery is reported. METHOD: Standard laparoscopic procedures with robot-assisted laparoscopic colon mobilization and vascular ligation were performed. Data relating to the operative procedure, hospital stay, and direct costs were collected. Results were compared with age, gender, and procedure case-matched controls taken from a prospective laparoscopic colorectal surgery database. RESULTS: Six robot-assisted laparoscopic surgeries (2 right hemicolectomies, 3 sigmoid colectomies, and 1 Wells rectopexy) were performed between December 2001 and June 2002. There was no associated morbidity. Operative time was increased from a median time of 108 minutes for standard laparoscopic colorectal surgery to 165 minutes for robot-assisted laparoscopic surgeries (P = 0.0313; Wilcoxon matched-pairs signed-rank test for non-parametric data). This was primarily a result of the time required for robot set-up. Blood loss, length of stay, and hospital cost were not significantly different between groups. Additional direct equipment costs for RAC cases included robotic laparoscopic instruments and sterile drapes (approximately US

Does means of access affect the incidence of small bowel obstruction and ventral hernia after bowel resection? ☆: Laparoscopy versus laparotomy

350 per case), without including acquisition and maintenance costs for the robot. CONCLUSION: Robot-assisted laparoscopic colectomy is a feasible and safe procedure. Although three-dimensional vision and dexterity are facilitated, operative time is increased and the overall additional expense of robotics is of concern. Robot-assisted laparoscopic colectomy requires further evaluation to establish clinical and financial benefits before introduction to routine practice. Such techniques may, in the future, facilitate complex laparoscopic techniques.

Clinical Outcomes and Resource Utilization Associated With Laparoscopic and Open Colectomy Using a Large National Database

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.

Prospective, Age-Related Analysis of Surgical Results, Functional Outcome, and Quality of Life After Ileal Pouch-Anal Anastomosis

Objectives:To clarify national clinical and economic laparoscopic colectomy outcomes, we conducted a study of patients who underwent colectomy by laparoscopic or open approaches. Background:Laparoscopy is becoming the preferred approach for colectomy in benign and malignant diseases. Although it is associated with significant clinical benefits, economic outcomes have varied. Methods:We analyzed cohorts of patient-level data from Premier Inc.s Perspective Rx Comparative Database, which collects data from more than 500 hospitals throughout the United States. By reviewing hospital charge data, patients who underwent elective colectomies from July 1, 2004, through June 30, 2006, were identified using International Classification of Diseases, 9th Revision, Clinical Modification procedure codes. The colectomy had to be listed as the primary or secondary procedure of the hospitalization. Primary outcomes included transfusion rates, in-hospital complications, readmissions within 30 days, reoperations, length of stay, total hospitalization costs, and discharge dispositions and services. Results:We identified 32,733 patients who had elective colectomies throughout 402 hospitals; 11,044 (33.7%) were laparoscopic and 21,689 (66.3%) were open colectomies. The mean age was 64.2 ± 13.9 years and 53.8% were women. Laparoscopic colectomy patients had a longer mean operative time (195 ± 76 vs. 178 ± 80 minutes; P < 0.0001) and higher total hospital costs (

Case-Matched Comparison of Clinical and Financial Outcome after Laparoscopic or Open Colorectal Surgery

8076 vs.

Pan-colonic decrease in interstitial cells of Cajal in patients with slow transit constipation

7678; P = 0.0002). Laparoscopic patients had shorter mean length of stay (7.0 vs. 8.1; P < 0.0001) and fewer mean intensive care unit days (0.7 ± 3.8 vs. 1.3 ± 5.2 days; P < 0.0001). The laparoscopic cohort also had lower rates of transfusions (odds ratio [OR] = 0.68; P < 0.0001), in-hospital complications (OR = 0.89; P < 0.0001), and readmissions within 30 days (OR = 0.89; P = 0.0051), although reoperation rates were slightly, but significantly increased (OR = 1.78; P = 0.002). Laparoscopic colectomy patients were more likely to be discharged home without nursing care (OR = 0.70; P < 0.0001). Conclusion:Evaluation of a national administrative data set showed that patients who underwent laparoscopic colectomy had shorter intensive care unit and total hospital stays, fewer complications, lower mortality, fewer readmissions, and less use of skilled nursing facilities after discharge. There was a small but significant increase in reoperation rates and in-hospital costs with laparoscopic colectomy. Improved application of enhanced recovery programs and operative efficiencies may further improve resource utilization associated with laparoscopic colectomy.