Robert R. Cima

Ano1 is a selective marker of interstitial cells of Cajal in the human and mouse gastrointestinal tract

Populations of interstitial cells of Cajal (ICC) are altered in several gastrointestinal neuromuscular disorders. ICC are identified typically by ultrastructure and expression of Kit (CD117), a protein that is also expressed on mast cells. No other molecular marker currently exists to independently identify ICC. The expression of ANO1 (DOG1, TMEM16A), a Ca(2+)-activated Cl(-) channel, in gastrointestinal stromal tumors suggests it may be useful as an ICC marker. The aims of this study were therefore to determine the distribution of Ano1 immunoreactivity compared with Kit and to establish whether Ano1 is a reliable marker for human and mouse ICC. Expression of Ano1 in human and mouse stomach, small intestine, and colon was investigated by immunofluorescence labeling using antibodies to Ano1 alone and in combination with antibodies to Kit. Colocalization of immunoreactivity was demonstrated by epifluorescence and confocal microscopy. In the muscularis propria, Ano1 immunoreactivity was restricted to cells with the morphology and distribution of ICC. All Ano1-positive cells in the muscularis propria were also Kit positive. Kit-expressing mast cells were not Ano1 positive. Some non-ICC in the mucosa and submucosa of human tissues were Ano1 positive but Kit negative. A few (3.2%) Ano1-positive cells in the human gastric muscularis propria were labeled weakly for Kit. Ano1 labels all classes of ICC and represents a highly specific marker for studying the distribution of ICC in mouse and human tissues with an advantage over Kit since it does not label mast cells.

Use of Lean and Six Sigma Methodology to Improve Operating Room Efficiency in a High-Volume Tertiary-Care Academic Medical Center

BACKGROUND Operating rooms (ORs) are resource-intense and costly hospital units. Maximizing OR efficiency is essential to maintaining an economically viable institution. OR efficiency projects often focus on a limited number of ORs or cases. Efforts across an entire OR suite have not been reported. Lean and Six Sigma methodologies were developed in the manufacturing industry to increase efficiency by eliminating non-value-added steps. We applied Lean and Six Sigma methodologies across an entire surgical suite to improve efficiency. STUDY DESIGN A multidisciplinary surgical process improvement team constructed a value stream map of the entire surgical process from the decision for surgery to discharge. Each process step was analyzed in 3 domains, ie, personnel, information processed, and time. Multidisciplinary teams addressed 5 work streams to increase value at each step: minimizing volume variation; streamlining the preoperative process; reducing nonoperative time; eliminating redundant information; and promoting employee engagement. Process improvements were implemented sequentially in surgical specialties. Key performance metrics were collected before and after implementation. RESULTS Across 3 surgical specialties, process redesign resulted in substantial improvements in on-time starts and reduction in number of cases past 5 pm. Substantial gains were achieved in nonoperative time, staff overtime, and ORs saved. These changes resulted in substantial increases in margin/OR/day. CONCLUSIONS Use of Lean and Six Sigma methodologies increased OR efficiency and financial performance across an entire operating suite. Process mapping, leadership support, staff engagement, and sharing performance metrics are keys to enhancing OR efficiency. The performance gains were substantial, sustainable, positive financially, and transferrable to other specialties.

Incidence and Characteristics of Potential and Actual Retained Foreign Object Events in Surgical Patients

BACKGROUND Incidence of retained foreign objects (RFOs) after operations is unknown, as many can go unrecognized for years. We reviewed the incidence and characteristics of surgical RFO events at a tertiary care institution during 4 years. STUDY DESIGN All RFO events, near misses and actual, reported on an adverse event line during 2003 to 2006 were reviewed. RESULTS During 2003 to 2006, there were 191,168 operations performed, with 68 reported events resulting in a potential RFO defect rate of 0.356/1,000 patients. After review, 34 patients had no RFOs (near misses) and 34 were actual RFOs, resulting in a true RFO defect rate of 0.178/1,000 operations or approximately 1:5,500 operations. In the near-miss patient, needles were miscounted 76% of the time. In the 34 actual RFO patients, items retained were 23 sponges (68%), 7 miscellaneous other items (20%), 3 needles (9%), and 1 instrument (3%). The 34 actual RFOs occurred in incidents where the count had been reported as correct in 21 patients (62%). In 18 patients where an RFO was eventually discovered, intraoperative imaging detected only 12 objects (67%). In operations involving a body cavity, our practice is to obtain a high-resolution x-ray survey film, in a dedicated x-ray suite, before entering the recovery room. Twenty RFOs were identified from survey films and all occurred in patients with correct counts. No RFOs occurred during emergency or high blood-loss procedures and none resulted in demonstrable clinical harm. Two patients left the hospital with an RFO. Twenty-two patients (64.8%) underwent reoperation, with 1 object not removed, 6 (17.6%) retrieved without operation, and 6 (17.6%) where the clinical decision was not to remove. CONCLUSIONS RFOs at an institution that routinely performs postprocedure x-rays indicate that RFOs can occur more frequently than expected from the literature. The majority occur in patients with correct counts. Relying on counting as the primary mechanism to avoid RFOs is unreliable, and investigating new technologies designed to achieve reliable counts is warranted.

Safety, Feasibility, and Short-term Outcomes of Laparoscopic Ileal-Pouch-Anal Anastomosis: A Single Institutional Case-Matched Experience

Objective:To compare safety and short-term outcomes of 100 laparoscopic ileal pouch-anal anastomosis (IPAA) versus 200 conventional open IPAA patients. Summary Background Data:Outcomes of laparoscopic IPAA (LAP-IPAA) have been incompletely characterized. Previous reports are characterized by small numbers of patients and rarely include case-matched or randomized trial methodology. This report describes 100 LAP-IPAA patients case matched to 200 open IPAA patients. Methods:Between 1998 and 2004, 100 consecutive LAP-IPAA patients (75 laparoscopic assisted, 25 hand assisted) were identified and case matched to 200 open IPAA control patients by age, operation, gender, date of operation, and body mass index. Operative and postoperative outcomes at 90 days were compared. Results:A total of 300 patients (180 female) with a median age of 32 years (range, 17–66 years), and a median body mass index of 23 kg/m2 (range, 16–34 kg/m2) underwent IPAA (100 LAP-IPAA, 200 open IPAA). Diagnosis (chronic ulcerative colitis 97%, familial adenomatous polyposis 3%) and previous operative history were equivalent between groups. One intraoperative complication occurred in each group. Overall, the laparoscopic conversion rate was 6%. Median operative time was longer for the LAP-IPAA group (333 minutes versus 230 minutes, P < 0.0001). LAP-IPAA patients had shorter median time to regular diet (3 versus 5 days), time to ileostomy output (2 versus 3 days), length of stay (4 versus 7 days), and decreased IV narcotic use (all P < 0.05.Postoperative morbidity was equivalent (LAP-IPAA = 33%, open IPAA = 37%), mortality was nil, and readmission rates were equal (LAP-IPAA = 21%, open IPAA = 22%). Reoperation was required in 3% of LAP-IPAA and 6.5% of open IPAA patients (P < 0.2) during the first 3 months. Conclusion:LAP-IPAA is equivalent to open IPAA in terms of safety and feasibility. In addition, LAP-IPAA provides significant improvements in short-term recovery outcomes.

How best to measure surgical quality? comparison of the Agency for Healthcare Research and Quality Patient Safety Indicators (AHRQ-PSI) and the American College of Surgeons National Surgical Quality Improvement Program (ACS-NSQIP) postoperative adverse events at a single institution

BACKGROUND Evaluating surgical outcomes is an important tool to compare providers and institutions and to drive process improvements. Differing methodologies, however, may provide conflicting measurements of similar clinical outcomes making comparisons difficult. ACS-NSQIP is a validated, risk-adjusted, clinically derived data methodology to compare observed to expected outcomes after a wide variety of operations. The AHRQ-PSI are a set of computer algorithms to identify potential adverse in-patient events using secondary ICD-9-CM diagnosis and procedure codes from hospital discharge abstracts. METHODS We compared the ACS-NSQIP and AHRQ-PSI methods for hospital general surgical (n = 6565) or vascular surgical inpatients procedures (n = 1041) at a tertiary-care academic institution from April 2006 to June 2009 on 7 adverse event types. RESULTS ACS-NSQIP inpatient adverse events were identified in 564 (7.4%) patients. AHRQ-PSIs were identified in 268 (3.5%) patients. Only 159 (2.1%) patients had inpatient events identified by both methods. Using ACS-NSQIP as the clinically based standard the sensitivity of the specific AHRQ-PSI ranged from 0.030 for infections to 0.535 for PE/DVT. Positive predictive values of AHRQ-PSI ranged from 18% for hemorrhage/hematoma to 89% for renal failure. Greater agreement at greater ASA class and wound classification was observed. CONCLUSION AHRQ-PSI algorithms identified less than a third of the ACS-NSQIP clinically important adverse events. Furthermore, the AHRQ-PSI identified a large number of events with no corresponding clinically important adverse outcomes. The sensitivity of the AHRQ-PSI for detecting clinically relevant adverse events identified by the ACS-NSQIP varied widely. The AHRQ-PSI as applied to postoperative patients is a poor measure of quality performance.

Expression of an extracellular calcium-sensing receptor in rat stomach

BACKGROUND & AIMS Circulating levels of Ca2+ can influence secretory functions and myoelectrical properties of the stomach. A Ca2+-sensing receptor (CaR) has recently been identified in tissues that regulate systemic Ca2+ homeostasis. The aim of this study was to evaluate expression of CaR in the stomach of the rat. METHODS In forestomach and glandular stomach, reverse-transcription polymerase chain reaction was used to amplify a 380-base pair product, which is 99% homologous with transcripts obtained in parathyroid and kidney. RESULTS Northern analysis of gastric mucosal polyA+ RNA revealed 7. 5- and 4.1-kilobase transcripts, similar to those obtained in rat parathyroid and kidney. Immunohistochemistry revealed CaR expression in regions of the submucosal plexus and myenteric neurons. In sections of intact tissue, preparations of primary culture surface cells and surgically dissected gastric glands, staining was observed consistently in epithelial cells of the gastric glands and in gastric surface cells. In parietal cells in isolated gastric glands, intracellular levels of Ca2+ responded to conditions that are known to activate CaR. CONCLUSIONS These are the first reported observations that CaR is expressed in different epithelial cells of mammalian gastric mucosa and its enteric nerve regions. The effects of extracellular Ca2+ on gastric function may be attributable to activation of CaR.

Colorectal Surgery Surgical Site Infection Reduction Program: A National Surgical Quality Improvement Program–Driven Multidisciplinary Single-Institution Experience

BACKGROUND Surgical site infections (SSI) are a major cause of morbidity in surgical patients and they increase health care costs considerably. Colorectal surgery is consistently associated with high SSI rates. No single intervention has demonstrated efficacy in reducing colorectal SSIs. The American College of Surgeons National Surgical Quality Improvement Program (ACS NSQIP) is a nationally validated system that uses clinically abstracted data on surgical patients and their outcomes to assist participating institutions drive quality improvement. STUDY DESIGN A multidisciplinary team was assembled to develop a colorectal SSI-reduction bundle at an academic tertiary care medical center. The ACS NSQIP data were used to identify patterns of SSIs during a 2-year period. Multiple interventions across the entire surgical episode of care were developed and implemented in January 2011. Monthly ACS NSQIP data were used to track progress. RESULTS Our ACS NSQIP overall colorectal SSI rate for 2009 and 2010 was 9.8%. One year after implementation of the SSI reduction bundle, we demonstrated a significant decline (p < 0.05) in both overall and superficial SSIs, to 4.0% and 1.5%, respectively. Organ space infections declined to 2.6%, which was not a significant change (p = 0.10). During the entire analysis period (2009 to 2011), there was no change in our colorectal-specific Surgical Care Improvement Program performance. CONCLUSIONS Using our ACS NSQIP colorectal SSI outcomes, a multidisciplinary team designed a colorectal SSI reduction bundle that resulted in a substantial and sustained reduction in SSIs. Our study is not able to identify which specific elements contributed to the reduction.

Effect of Age on the Enteric Nervous System of the Human Colon

Abstract  The effect of age on the anatomy and function of the human colon is incompletely understood. The prevalence of disorders in adults such as constipation increase with age but it is unclear if this is due to confounding factors or age‐related structural defects. The aim of this study was to determine number and subtypes of enteric neurons and neuronal volumes in the human colon of different ages. Normal colon (descending and sigmoid) from 16 patients (nine male) was studied; ages 33–99. Antibodies to HuC/D, choline acetyltransferase (ChAT), neuronal nitric oxide synthase (nNOS), and protein gene product 9.5 were used. Effect of age was determined by testing for linear trends using regression analysis. In the myenteric plexus, number of Hu‐positive neurons declined with age (slope = −1.3 neurons/mm/10 years, P = 0.03). The number of ChAT‐positive neurons also declined with age (slope = −1.1 neurons/mm/10 years of age, P = 0.02). The number of nNOS‐positive neurons did not decline with age. As a result, the ratio of nNOS to Hu increased (slope = 0.03 per 10 years of age, P = 0.01). In the submucosal plexus, the number of neurons did not decline with age (slope = −0.3 neurons/mm/10 years, P = 0.09). Volume of nerve fibres in the circular muscle and volume of neuronal structures in the myenteric plexus did not change with age. In conclusion, the number of neurons in the human colon declines with age with sparing of nNOS‐positive neurons. This change was not accompanied by changes in total volume of neuronal structures suggesting compensatory changes in the remaining neurons.

Association of hospital participation in a surgical outcomes monitoring program with inpatient complications and mortality.

IMPORTANCE Programs that analyze and report rates of surgical complications are an increasing focus of quality improvement efforts. The most comprehensive tool currently used for outcomes monitoring in the United States is the American College of Surgeons (ACS) National Surgical Quality Improvement Program (NSQIP). OBJECTIVE To compare surgical outcomes experienced by patients treated at hospitals that did vs did not participate in the NSQIP. DESIGN, SETTING, AND PARTICIPANTS Data from the University HealthSystem Consortium from January 2009 to July 2013 were used to identify elective hospitalizations representing a broad spectrum of elective general/vascular operations in the United States. Data on hospital participation in the NSQIP were obtained through review of semiannual reports published by the ACS. Hospitalizations at any hospital that discontinued or initiated participation in the NSQIP during the study period were excluded after the date on which that hospitals status changed. A difference-in-differences approach was used to model the association between hospital-based participation in NSQIP and changes in rates of postoperative outcomes over time. EXPOSURE Hospital participation in the NSQIP. MAIN OUTCOMES AND MEASURES Risk-adjusted rates of any complications, serious complications, and mortality during a hospitalization for elective general/vascular surgery. RESULTS The cohort included 345,357 hospitalizations occurring in 113 different academic hospitals; 172,882 (50.1%) hospitalizations were in NSQIP hospitals. Hospitalized patients were predominantly female (61.5%), with a mean age of 55.7 years. The types of procedures performed most commonly in the analyzed hospitalizations were hernia repairs (15.7%), bariatric (10.5%), mastectomy (9.7%), and cholecystectomy (9.0%). After accounting for patient risk, procedure type, underlying hospital performance, and temporal trends, the difference-in-differences model demonstrated no statistically significant differences over time between NSQIP and non-NSQIP hospitals in terms of likelihood of complications (adjusted odds ratio, 1.00; 95% CI, 0.97-1.03), serious complications (adjusted odds ratio, 0.98; 95% CI, 0.94-1.03), or mortality (adjusted odds ratio, 1.04; 95% CI, 0.94-1.14). CONCLUSIONS AND RELEVANCE No association was found between hospital-based participation in the NSQIP and improvements in postoperative outcomes over time within a large cohort of patients undergoing elective general/vascular operations at academic hospitals in the United States. These findings suggest that a surgical outcomes reporting system does not provide a clear mechanism for quality improvement.

Laparoscopic-Assisted vs. Open Ileal Pouch-Anal Anastomosis: Functional Outcome in a Case-Matched Series

PURPOSEFunctional outcomes in laparoscopic-assisted ileal pouch-anal anastomosis have been incompletely studied. More than one-year follow-up has rarely been reported in these patients. This study was designed to assess operative, functional, and quality of life outcomes in patients with ulcerative colitis or familial adenomatous polyposis a minimum of one year after.METHODSThirty-three laparoscopic-assisted ileal pouch-anal anastomosis and 33 open ileal pouch-anal anastomosis patients, with a median of 13 months and minimum of 12 months follow-up, were identified from a prospective, laparoscopic database. Functional outcome was prospectively assessed by using a standardized survey. These cohorts were matched by individual patient for year of surgery, age, gender, body mass index, and indication.RESULTSMedian age was 27 years (open) and 28 years (laparoscopic). There were 27 females and 6 males in each group. All operations occurred between 1999 and 2001. Median body mass index was 22.3 (open) and 21.7 (laparoscopic) groups. There were no significant differences in diagnosis, use of diversion, and anastomotic technique. Postoperative morbidity occurred in 6 percent of the laparoscopic cases and 12 percent of the open cases. Functional outcome after a minimum of one year revealed equivalent median day and median nocturnal number of stools of six to seven and one to two respectively. Consistency of stool, medication usage, and continence were no different between groups. Daytime and nocturnal incontinence was similar. Quality of life in regard to social, home life, family, travel, sports, recreation, and sex life were equivalent.CONCLUSIONSThe function and quality of life outcomes for patients undergoing laparoscopic-assisted ileal pouch-anal anastomosis seem to be equivalent to our open experience. Laparoscopic-assisted ileal pouch-anal anastomosis offers selected patients a safe, feasible, and durable alternative.