Determinants of variability in management of acute calculous cholecystitis.

BACKGROUND: While evidence supports early compared to delayed cholecystectomy as optimal management of acute calculous cholecystitis (ACC), significant variability in practice remains. The purpose of this study was to identify variables associated with early cholecystectomy, to target opportunities to improve adherence to best practices. METHODS: Adult patients admitted to surgical units with ACC at two hospitals in a university hospital network between June 2010 and January 2015 were reviewed. Patients with concurrent pancreatitis, cholangitis or severe ACC (with organ system failure) were excluded. Early cholecystectomy was defined as surgery performed during same admission and within 7 days of presentation. Non-operative management was defined as admission for ACC treated conservatively, with or without eventual delayed cholecystectomy. The primary outcome was early cholecystectomy versus initial non-operative management; secondary outcomes included time to cholecystectomy, complications, and total hospital length of stay (LOS). RESULTS: A total of 374 patients were included. Two hundred and forty six patients (66%) underwent early cholecystectomy, 60 (16%) were treated non-operatively and had delayed cholecystectomy, and 68 (18%) were only treated non-operatively. Median time to OR from initial presentation was 38 h [22-63] for early cholecystectomy patients and 69 days [29-116] for the non-operative patients who had delayed cholecystectomy. When comparing both groups, early cholecystectomy patients were younger and were treated more often at site 1. There were no differences in complications during hospitalization, but early cholecystectomy patients had a lower median total LOS (3 [2-5] vs. 5 [4-9], p < 0.001), and they had fewer gallstone-related events after discharge (1 vs. 18%, p < 0.001). On multiple logistic regression analysis, lower age, hospital site and lower risk of concurrent choledocholithiasis were all significantly associated with early cholecystectomy (p < 0.05). CONCLUSION: Our data supports early cholecystectomy as best practice in management of ACC with no differences in complications during hospitalization, shorter median LOS and fewer gallstone-related events compared to non-operative management. We identified patient and institutional factors associated with early cholecystectomy. This suggests that multiple strategies will be necessary to promote adherence to best practices in the management of ACC within our institution.

Biologic mesh for repair of ventral hernias in contaminated fields: long-term clinical and patient-reported outcomes.

BACKGROUND: Guidelines recommend biologic prosthetics for ventral hernia repair (VHR) in contaminated fields, yet long-term and patient-reported data are limited. We aimed to determine the long-term rate of hernia recurrence, and other clinical and patient-reported outcomes following the use of porcine small intestine submucosa (PSIS) for VHR in a contaminated field. METHODS: Consecutive patients undergoing open VHR with PSIS mesh in a contaminated field from 2004 to 2014 were prospectively evaluated for hernia recurrence and other post-operative complications. Multivariate logistic and Cox regression analyses identified predictors of hernia recurrence and surgical site infection. Patient-reported outcomes were evaluated using SF-36, Hernia-Related Quality-of-Life Survey (HerQLes) and Body Image Questionnaire instruments. RESULTS: Forty-six hernias were repaired in clean-contaminated [16 (35 %)], contaminated [11 (24 %)] and dirty [19 (41 %)] fields. Median follow-up was 47 months [interquartile range: 31-79] and all patients had greater than 12-month follow-up. Sixteen patients (35 %) were not re-examined. Incidence of surgical site events and surgical site infection were 43 % (n = 20) and 56 % (n = 25), respectively. American Society of Anesthesiologists score 3 or greater was an independent predictor of surgical site infection (odds ratio 5.34 [95 % confidence interval 1.01-41.80], p = 0.04). Hernia recurrence occurred in 61 % (n = 28) with a median time to diagnosis of 16 months [interquartile range 8-26]. After bridged repair, 16 of 18 patients (89 %) recurred, compared to 12 of 28 (43 %) when fascia was approximated (p < 0.01). Bridged repair was an independent predictor of recurrence (odds ratio 10.67 [95 % confidence interval 2.42-76.08], p < 0.01). Patients with recurrences had significantly worse scores on the SF-36 mental health component and self-perceived body image, whereas HerQLes scores were similar. CONCLUSIONS: Hernia recurrences and wound infections are high with the use of biologic PSIS mesh in contaminated surgical fields. Careful consideration is warranted using this approach.

Camera navigation and cannulation: validity evidence for new educational tasks to complement the Fundamentals of Laparoscopic Surgery program.

BACKGROUND: Experts identified camera navigation and cannulation as important skills that are not assessed by the Fundamentals of Laparoscopic Surgery (FLS) hands-on examination. The purpose of this study was to create metrics for and evaluate the validity for two new tasks: camera navigation (N) and cannulation (C), and to explore the potential value of adding these tasks to the FLS program. METHODS: Participants were assessed by two raters during performance of N and C in addition to the five standard FLS tasks. They also completed a questionnaire regarding the educational value of the new tasks. Validity evidence was assessed by comparing performance between Novice (PGY 1 and 2) and Experienced (PGY 3 and higher) participants, and by correlating new task scores with standard FLS scores. The ability to predict level of training using scores was evaluated by regression analysis. RESULTS: Sixty subjects participated from five North American centers. Inter-rater reliabilities for both tasks were 0.99. Novice and Experienced participants scored 74 ± 17.8 versus 85 ± 8.3 (p < 0.01) and 21 ± 17.3 versus 39 ± 20.1 (p < 0.01) on N and C tasks, respectively. Correlations with total FLS scores for N and C were 0.39 and 0.53, respectively. Prediction of training level using the combination of all seven tasks was 52.6 % (R (2) = 0.526, p < 0.01), adding an additional 2.2 % to the five FLS tasks. Of 55 participants with laparoscopic experience, 51 % reported N to be similar in difficulty to reality. Of 28 participants who perform intraoperative cholangiograms, 43 % found C to be more difficult than reality. Most (70 %) participants thought the new tasks added value to FLS. CONCLUSIONS: This study provides preliminary validity evidence for the metrics of these new tasks. The value of adding these tasks to the FLS manual skills assessment is marginal in terms of predicting level of training.

Simulation-based training improves the operative performance of totally extraperitoneal (TEP) laparoscopic inguinal hernia repair: a prospective randomized controlled trial.

BACKGROUND: Laparoscopic surgery has an important role to play in the care of patients with inguinal hernias, but the procedure is difficult to learn. This study aimed to assess whether training to proficiency using a novel laparoscopic inguinal hernia repair (LIHR) simulation curriculum improved operating room (OR) performance. METHODS: For this study, 17 surgical residents [postgraduate years (PGYs) 2-5] participated in a didactic LIHR course and then were randomized to a training (T) or a control (C, standard residency) group. Performance of totally extraperitoneal (TEP) LIHR in the OR at baseline and after the study was measured using the Global Operative Assessment of Laparoscopic Skills-Groin Hernia (GOALS-GH). RESULTS: Of the 17 residents, 14 (5 T and 9 C) completed their final evaluations. The two groups showed no differences in terms of LIHR experience. The baseline GOALS-GH scores in the OR were similar (T 14.8; range 12.8-16.8 vs. C 13.6; range 12.3-14.8; P = 0.20). The mean number of training sessions needed to achieve proficiency was 4.8 (range 4.4-5.2), and the mean total training time was 109 min (range 61.9-149.1 min). After training, OR performance improved in the T group by 3.4 points (range 2.0-4.8 points; P = 0.002), whereas no significant change was seen in the C group [1.2; (range -1.1 to 3.6; P = 0.27)]. The final total GOALS-GH scores showed a trend toward better performance in the T group than in the C group [18.2; (range 14.9-21.5) vs. 14.8; (range 12.4-17.1); P = 0.06). CONCLUSIONS: This study demonstrated the skills required for transfer of LIHR to the OR using a low-cost procedure-specific simulator. Residents who trained to proficiency on the McGill Laparoscopic Inguinal Hernia Simulator (MLIHS) showed greater skill improvement than their colleagues who did not. These results provide evidence supporting the use of simulation to teach and assess LIHR.

Evaluation of surgical performance during laparoscopic incisional hernia repair: a multicenter study.

BACKGROUND: Laparoscopic incisional hernia repair (LIHR) is a common procedure requiring advanced laparoscopic skills. This study aimed to develop a procedure-specific tool to assess the performance of LIHR and to evaluate its reliability and validity. METHODS: The Global Operative Assessment of Laparoscopic Skills-Incisional Hernia (GOALS-IH) is a 7-item global rating scale developed by experts to evaluate the steps of LIHR (placement of trocars, adhesiolysis, estimation of mesh size and shape, mesh orientation and positioning, mesh fixation, knowledge and autonomy in use of instruments, overall competence), each rated on a 5-point Likert scale. During LIHR, 13 attending surgeons and fellows experienced in minimally invasive surgery (MIS) and 19 novice surgeons (postgraduate years [PGYs], 3-5) were evaluated at four teaching hospitals by the attending surgeon, a trained observer, and self-assessment using GOALS-IH, and by a previously validated 5-item general laparoscopic rating scale (GOALS). Interrater reliability was assessed by intraclass correlation (ICC), and internal consistency of rating items was assessed by Cronbach's alpha. Known-groups construct validity was assessed by using the t-test and by correlating of the number of self-reported LIHR cases with the total score. Concurrent validity was assessed by correlating the GOALS-IH score with the GOALS general rating scale. Data are presented as mean and 95% confidence interval (CI). RESULTS: Interrater reliability for the total GOALS-IH score was 0.79 (95% CI, 0.60-0.89) between observers and attending surgeons, 0.81 (95% CI, 0.58-0.92) between participants and attending surgeons, and 0.89 (95% CI, 0.76-0.96) between participants and observers. Internal consistency was high (Cronbach's alpha, 0.93). Experienced surgeons performed significantly better than novices as assessed by GOALS-IH (31; 95% CI, 29-33 vs. 21; 95% CI, 19-24; p < 0.01). Very good correlation was found between GOALS-IH and previous LIHR experience (r = 0.82; p < 0.01) and strong correlation between GOALS-IH and generic GOALS total scores (r = 0.90; p < 0.01). CONCLUSION: Surgical performance during clinical LIHR can be assessed reliably using GOALS-IH. Results can be used to provide formative feedback to the surgeon and to identify steps of the operation that would benefit from specific educational interventions.

Global Assessment of Gastrointestinal Endoscopic Skills (GAGES): a valid measurement tool for technical skills in flexible endoscopy.

BACKGROUND: Simulators may improve the efficiency, safety, and quality of endoscopic training. However, no objective, reliable, and valid tool exists to assess clinical endoscopic skills. Such a tool to measure the outcomes of educational strategies is a necessity. This multicenter, multidisciplinary trial aimed to develop instruments for evaluating basic flexible endoscopic skills and to demonstrate their reliability and validity. METHODS: The Global Assessment of Gastrointestinal Endoscopic Skills (GAGES) Upper Endoscopy (GAGES-UE) and Colonoscopy (GAGES-C) are rating scales developed by expert endoscopists. The GAGES scale was completed by the attending endoscopist (A) and an observer (O) in self-assessment (S) during procedures to establish interrater reliability (IRR, using the intraclass correlation coefficient [ICC]) and internal consistency (IC, using Cronbach's alpha). Instrumentation was evaluated when possible and correlated with total scores. Construct and external validity were examined by comparing novice (NOV) and experienced (EXP) endoscopists (Student's t-test). Correlations were calculated for GAGES-UE and GAGES-C with participants who had performed both. RESULTS: For the 139 completed evaluations (60 NOV, 79 EXP), IRR (A vs. O) was 0.96 for GAGES-UE and 0.97 for GAGES-C. The IRR between S and A was 0.78 for GAGES-UE and 0.89 for GAGES-C. The IC was 0.89 for GAGES-UE, and 0.95 for GAGES-C. There were mean differences between the NOV and the EXP endoscopists for GAGE-UE (14.4 +/- 3.7 vs. 18.5 +/- 1.6; p < 0.001) and GAGE-C (11.8 +/- 3.8 vs. 18.8 +/- 1.3; p < 0.001). Good correlation was found between the scores for the GAGE-UE and the GAGE-C (r = 0.75; n = 37). Instrumentation, when performed, demonstrated correlations with total scores of 0.84 (GAGE-UE; n = 73) and 0.86 (GAGE-C; n = 45). CONCLUSIONS: The GAGES-UE and GAGES-C are easy to administer and consistent and meet high standards of reliability and validity. They can be used to measure the effectiveness of simulator training and to provide specific feedback. The GAGES results can be generalized to North American and European endoscopists and may contribute to the definition of technical proficiency in endoscopy.

Single-port laparoscopic colorectal surgery: early clinical experience.

BACKGROUND: Single-port laparoscopic surgery (SPLS) for colorectal pathology is an advanced technique wherein laparoscopic surgery is carried out through a single small incision hidden in the umbilicus. Advantages of this technique over standard laparoscopy are still under investigation. This study reports the initial experience and short-term outcomes of colorectal SPLS procedures in a single academic-based institution. SUBJECTS AND METHODS: All patients who underwent SPLS for colorectal procedures between February 2010 and March 2011 were recruited into this prospective study. Patients' demographics, pathology, and intraoperative and postoperative outcomes were collected. Time to first flatus and bowel movement, postoperative pain, duration of hospital stay, and complications were also measured. RESULTS: Twenty patients underwent colorectal SPLS: 17 patients underwent right hemicolectomy, and 3 patients had sigmoid resection. Mean age was 66±14 years, and body mass index was 25±4 kg/m(2). Median operative time for right hemicolectomy was 120 minutes (range, 110-136 minutes), and that for sigmoid resection was 158 minutes (range, 86-177 minutes). Mean measured incision length was 4.2±1.2 cm (range, 2.5-7 cm). Two cases were converted to standard multiport laparoscopy, and 1 was converted to open surgery Postoperatively, there was no mortality. Intra-abdominal abscess was observed in 3 patients. Median postoperative stay was 3 days (range, 3-3 days). Median number of lymph nodes extracted was 15 (range, 12-23). CONCLUSIONS: The SPLS is technically feasible with proper patient selection for a variety of applications in colorectal surgery. Improvement in instrumentation and technology is likely to expand the role of SPLS in minimally invasive surgery. It is important to audit outcomes as this novel approach is introduced.

A tool for training and evaluation of laparoscopic inguinal hernia repair: the Global Operative Assessment Of Laparoscopic Skills-Groin Hernia (GOALS-GH).

BACKGROUND: the purpose of this study was to develop an assessment tool specific to laparoscopic inguinal hernia repair (LIHR), and to evaluate its reliability and validity in the operating room (OR) and skills laboratory. METHODS: the Global Operative Assessment of Laparoscopic Skills-Groin Hernia (GOALS-GH) was developed by surgeon-educators. Participants were assessed in the OR and/or on a physical simulator using GOALS-GH. Interrater reliability, internal consistency, and construct and concurrent validity were evaluated for 23 participants. RESULTS: the interrater reliability of GOALS-GH was >.70 for all raters in the OR and during simulated LIHR. The internal consistency of GOALS-GH items was .97. The mean total GOALS-GH score for experts was significantly higher than for novices in both environments. The correlation between GOALS-GH scores in the OR and simulator was .81 (P < .01; n = 12). CONCLUSIONS: GOALS-GH is an objective, reliable, and valid measure of the skills required to perform LIHR.

Performance of simulated laparoscopic incisional hernia repair correlates with operating room performance.

BACKGROUND: the role of simulation for training in procedures such as laparoscopic incisional hernia repair (LIHR) is unknown. The purpose of this study was to determine whether performance in simulated LIHR correlates with operating room (OR) performance. METHODS: subjects performed LIHR in the University of Maryland Surgical Abdominal Wall (SAW) simulator and the OR. Trained observers used a LIHR-specific global rating scale (Global Operative Assessment of Laparoscopic Skills-Incisional Hernia) to assess performance. Global Operative Assessment of Laparoscopic Skills-Incisional Hernia includes 7 domains (trocar placement, adhesiolysis, mesh sizing, mesh positioning, mesh fixation, knowledge and autonomy in instrument use, and overall competence). The correlation between simulator and OR performance was assessed using the Pearson coefficient. RESULTS: fourteen surgeons from 2 surgical departments participated. Experienced surgeons (n = 9) were defined as attending surgeons and minimally invasive surgury (MIS) fellows, and novice surgeons (n = 5) were general surgery residents (postgraduate years 3-5). The correlation between performance in the OR and the simulator for the entire group was .87 (95% confidence interval, .63-.96; P < .001). CONCLUSIONS: there was an excellent correlation between LIHR performance in the simulator and clinical LIHR. This suggests that performance in the SAW simulator may predict performance in the operating room.

Fundamentals of laparoscopic surgery simulator training to proficiency improves laparoscopic performance in the operating room-a randomized controlled trial.

BACKGROUND: The purpose of this study was to assess whether training to proficiency with the Fundamentals of Laparoscopic Surgery (FLS) simulator would result in improved performance in the operating room (OR). METHODS: Nineteen junior residents underwent baseline FLS testing and were assessed in the OR using a validated global rating scale (GOALS) during elective laparoscopic cholecystectomy. Those with GOALS scores

How should we establish the clinical case numbers required to achieve proficiency in flexible endoscopy?

BACKGROUND: Recommended procedure numbers for upper endoscopy (UE) and colonoscopy (C) are 35 and 50 for surgical residents, and 130 and 140 for gastroenterology fellows, respectively. The purpose of this study was to challenge the methods used to determine proficiency in flexible endoscopy. METHODS: Global assessment of gastrointestinal endoscopic skills (GAGES) was used to evaluate 139 procedures. Scores for UE were compared using self-reported case numbers and grouped according to requirements for each discipline. C scores were compared using the requirements to define novice and experienced endoscopists. Procedure volumes were plotted against GAGES scores. RESULTS: Three groups were compared for UE based on case volumes: fewer than 35 cases (group 1), 35 to 130 cases (group 2), and more than 130 cases (group 3). There was no difference between group 2 (17.8 +/- 1.8) and group 3 (19.1 +/- 1.1), but both scored higher than group 1 (14.4 +/- 3.7; P < .05). For C, the scores were 11.8 +/- 3.8 (novices) and 18.8 +/- 1.34 (experienced; P < .001) at a 50-case minimum and 12.4 +/- 4.2 and 18.8 +/- 1.3 (P < .001) for a 140-case proficiency cut-off level, respectively. The curve of procedures versus GAGES plateaued at 50 (UE) and 75 (C). CONCLUSIONS: The surgical and gastroenterology case recommendations may not represent the experience needed to achieve proficiency. GAGES scores could help define proficiency in basic endoscopy.