Evaluating intraoperative laparoscopic skill: direct observation versus blinded videotaped performances.

The Global Operative Assessment of Laparoscopic Skill (GOALS) has been shown to meet high standards for direct observation. The purpose of this study was to investigate the reliability and validity of GOALS when applied to blinded, videotaped performances. Five novice surgeons and 5 experienced surgeons were each evaluated by 2 observers during a laparoscopic cholecystectomy. Subsequently, 4 laparoscopists (V1 to V4) evaluated the videotaped procedures using GOALS. Two of the raters (V1 and V3) had prior experience using GOALS. The interrater reliabilities between video raters (VRs) and between VRs and direct raters (DRs) were calculated using the intraclass correlation coefficient. Construct validity was assessed using 2-way analysis of variance. Interrater reliability between the 4 VRs and the 2 DRs was 0.72. The intraclass correlation coefficient for the 4 VRs was 0.68 and for each VR compared with the mean DR was 0.86, 0.39, 0.94, and 0.76, respectively. All raters, except V2, differentiated between novice and experienced groups (P values ranged from .01 to .05). These data suggest that GOALS can be used to assess laparoscopic skill based on videotaped performances but that rater training may play an important role in ensuring the reliability and validity of the instrument. Experience with the tool in the operating room may improve the reliability of video rating and could be of value in training evaluators.

Targeting individual hemodynamics to maintain renal perfusion during pneumoperitoneum in a porcine model.

BACKGROUND: Although aggressive fluid hydration prevents a decrease in renal cortical perfusion (RCP) during laparoscopic donor nephrectomy, excess fluid is deleterious. We assessed whether goal-directed fluid administration, based on hemodynamic measures, would maintain RCP during pneumoperitoneum with less fluid loading. METHODS: In a pilot study of 7 pigs, goal-directed fluid administration was guided by monitoring of stroke volume (SV) by esophageal Doppler measurement. During 15 mmHg CO(2) pneumoperitoneum, a bolus of 5 mL/kg 0.9% NaCl was given when SV decreased to 90% of baseline. Next, 18 pigs were randomized into 3 groups: low fluid (5 mL/kg per hour), high fluid (25 mL/kg per hour) and goal directed. Urine output, heart rate, mean arterial pressure, cardiac output, SV, and RCP were recorded every 15 minutes. RESULTS: Pilot data revealed mean RCP (mL/min per 100 g) was maintained (40 vs 39) during pneumoperitoneum using goal-directed therapy. In the randomized study, RCP was decreased in the low fluid group (43 vs 29; P= .02), but maintained in the high (46 vs 40) and goal-directed (42 vs 39) groups. Mean fluid administered in the goal-directed group during pneumoperitoneum was 10 mL/kg and only 3 of 6 of pigs required boluses. Urine output was decreased in all 3 groups. CONCLUSION: A goal-directed strategy during pneumoperitoneum allows for tailored fluid administration and maintains RCP with lower volumes of intravenous fluid.

Laparoscopic live donor nephrectomy: the pediatric recipient in a dual-site program.

BACKGROUND: At our institution, laparoscopic live donor nephrectomy (LLDN) is done at a different hospital site than pediatric recipient transplantation, whereas open donor nephrectomy (OLDN) is done in the adjacent operating room. The purpose of this study was to evaluate the safety of a dual-site renal transplantation program by comparing the outcomes of pediatric recipients of LLDN vs. OLDN. METHODS: This is a retrospective study of consecutive pediatric recipients (n = 10) of LLDN (June 2002 to June 2005) compared to the 10 most recent pediatric recipients of OLDN (March 2001 to June 2005). Renal function was assessed with calculated creatinine clearance using the Schwartz formula and the following outcomes were assessed: delayed graft function, ureteral complications, acute rejection and patient and graft survival. Results are expressed as median (IQR). RESULTS: When comparing the laparoscopic vs. open group, there were no significant differences in recipient age, height, weight, preoperative calculated creatinine clearance and warm ischemia time. Twelve month postoperative creatinine clearance was 88 ml/min/1.73 m(2) (57-99) in the laparoscopic group (n = 8) and 66 ml/min/1.73 m(2) (60-86) in the open group (n = 9), p = 0.2. In the LLDN group vs. the OLDN group, delayed graft function was 0% vs. 10% (p = 1.0), ureteral complications were 20% vs. 30% (p = 1.0), and acute rejection was 20% vs. 40% (p = 0.6). In the laparoscopic group, one-yr patient and graft survival were both 100%, as compared to 100% and 89%, respectively, in the open group. CONCLUSION: A dual-site laparoscopic donor nephrectomy program is not associated with adverse pediatric recipient outcomes when compared to a same-site open donor approach.

Patient perception of a clinical pathway for laparoscopic foregut surgery.

Clinical pathways have been implemented for a number of surgical procedures, yet few data are available that explore the patients' perception of these changes in clinical practice. A clinical pathway was developed for laparoscopic fundoplication, Heller myotomy, and paraesophageal hernia repair. Data collected from a cohort of patients undergoing surgery with the pathway over a 12-month period was compared with a group of patients operated on in the 12 months prior to pathway implementation. A questionnaire examining patient-based outcomes and perceptions was completed 6 weeks after surgery. From November 2001 through November 2003, 49 patients underwent primary laparoscopic foregut surgery, 27 before and 22 after pathway implementation. There were no differences in age, gender, procedure, or ASA Class. Parenteral opioid use diminished significantly without compromising the patients' perceived pain control. The number of patients undergoing postoperative investigations diminished, as did length of stay. Of the 20 post-pathway patients completing satisfaction questionnaires, 95% were satisfied or very satisfied with their care during admission. Pathway implementation resulted in a significant reduction in direct postoperative hospital costs. A clinical pathway for laparoscopic foregut surgery was successfully implemented in a single-payer system, resulting in decreased utilization of hospital resources while maintaining high patient satisfaction.

Elucidating the relationship between cardiac preload and renal perfusion under pneumoperitoneum.

INTRODUCTION: Pneumoperitoneum is associated with a well-described decrease in renal blood flow, but it remains unclear whether a decrease in cardiac preload is responsible. Our aim was to characterize the relationship between cardiac preload and renal perfusion during pneumoperitoneum. METHODS: Eleven pigs were submitted to three 30 minute study periods: 1) Baseline (n=11): no interventions, 2) Pneumoperitoneum (n=11): 12 mmHg CO2 pneumoperitoneum, 3) Preload Reduction: pneumoperitoneum and nitroglycerin infusion (n=8); or pneumoperitoneum and hemorrhage to a mean arterial pressure (MAP) of 40 mmHg (n=3). Echocardiographic measurements of left ventricular end-diastolic diameter (LVEDD) were used as an index of preload. Renal cortical perfusion (RCP) was measured using laser doppler flowmetry. RESULTS: LVEDD decreased from 4.2 +/- 0.5 to 4.1 +/- 0.6 cm (p=0.02) with pneumoperitoneum and then to 4.0 +/- 0.5 cm (p=0.03) with the addition of nitroglycerin. There was no statistically significant change in RCP with pneumoperitoneum (33.5 +/- 8.4 to 28.5 +/- 8.4 ml/min/100g tissue, p=0.2), but it decreased to 18.5 +/- 11.3 ml/min/100g tissue (p=0.001) with the addition of nitroglycerin. The correlation between RCP and LVEDD was weak (0.35, p=0.003), whereas correlation between RCP and MAP was superior (R=0.59, p<0.0001). CONCLUSIONS: While decreasing preload under extreme lab conditions also decreases RCP, simply creating a pneumoperitoneum of 12 mmHg does not. The decrease in renal blood flow associated with pneumoperitoneum is likely not solely a function of preload.

Has the introduction of laparoscopic Heller myotomy altered the treatment paradigm of achalasia?

Although surgical myotomy is well established as the most effective and durable treatment for achalasia, wide acceptance of this procedure as a first-line treatment has been hampered by perceived invasiveness and morbidity. Laparoscopic myotomy has significantly reduced surgical trauma and morbidity while maintaining effectiveness. The effect of laparoscopic myotomy on the treatment pattern for achalasia is not currently known. All patients undergoing surgical myotomy in Quebec from 1997 to 2002 were identified from the Régie de l'assurance maladie du Québec billing database; previous endoscopic treatment was documented from 1990 to the time of surgery. Patients were divided into two groups (prelaparoscopy and postlaparoscopy) defined by the approximate date when laparoscopic myotomy became generally available in Quebec. A questionnaire examining treatment preference for achalasia was sent to all Quebec gastroenterologists. The number of myotomies performed in Quebec remained stable (prelaparoscopy = 28.7/year; postlaparoscopy = 33/year), but were performed on an older population. The rate of preoperative endoscopic treatment did not differ from prelaparoscopy (29.2%) to postlaparoscopy (23.3%). However, the time interval between the last endoscopy and myotomy diminished significantly. Questionnaire response rate was 41% (60 of 147). Although myotomy was recognized as the most effective treatment (54 of 60), only 22 of 60 gastroenterologists would refer a healthy patient for myotomy as initial treatment. Other choices included dilation (33 of 60), Botulinum toxin (two of 60) or calcium channel blockade (three of 60). Despite a decrease in time interval between endoscopic treatment and surgery, no decrease in the rate of existing endoscopic therapies occurred after laparoscopic myotomy became widely available. The benefits and minimal risks associated with laparoscopic myotomy need to be more effectively communicated by referring physicians.

Measuring surgical recovery: the study of laparoscopic live donor nephrectomy.

Following laparoscopic donor nephrectomy (LDN), recovery has only been studied using traditional outcomes, subjective and confounded by comorbidity and psychosocial variables. The purpose of this study is to estimate surgical recovery following LDN using standardized, validated instruments and to compare this recovery profile to that obtained with traditional measures. This was a prospective study of patients undergoing LDN at a single institution between September 2001 and January 2004 (n = 35). At baseline and 4 weeks following surgery, functional exercise capacity was measured using the 6-min walk test (6MWT) and health-related quality of life was assessed with the Short Form-36 (SF-36) questionnaire, including physical component summary (PCS) and mental component summary (MCS) scores. Patients' self-assessment of recovery and time to resumption of regular activities was ascertained. At follow-up (median 29 days), patients' 6MWT was lower by a median of 30 m (p = 0.07) and PCS decreased from 57.1 to 42.3 (p = 0.0001), whereas MCS remained constant. Overall, length of stay, return to activities and patient-stated recovery were inadequate outcomes for classifying patient recovery using 6MWT and PCS as the reference standards. Four weeks following LLDN, patients have returned to baseline exercise capacity, but not baseline general physical health. Traditional measures of recovery are incomplete descriptors of recovery.

Validity of the MISTELS simulator for laparoscopy training in urology.

BACKGROUND AND PURPOSE: The McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) consists of a series of five laparoscopic exercises performed in an endotrainer box. MISTELS has been validated for use in both training and evaluation of general surgery residents in fundamental laparoscopic skills. The purpose of this study was to demonstrate the construct validity of MISTELS for urology residents. SUBJECTS AND METHODS: Seventeen participants were evaluated during performance of the five MISTELS tasks (peg transfer, pattern cutting, ligating loop, and suturing with extracorporeal and intracorporeal knots) using the standardized scoring system, which rewards both speed and precision. Participants included 13 urology residents (PGY 1-5), 1 fellow, and 3 urologists experienced in laparoscopy. Results are expressed as median (range). The Mann-Whitney U-test was used to compare MISTELS scores for 9 novice (PGY 1-4) and 8 experienced urologists (PGY 5-attending). P < 0.05 was considered statistically significant. RESULTS: The median MISTELS total normalized score for novices was 52.3 (range 15-68.9) compared with 71.7 (range 56.3-82.9) for experienced urologists (P = 0.007). Although the experienced group achieved higher scores in all five individual tasks, statistically significant differences were demonstrated for the peg transfer and intracorporeal suture tasks only. CONCLUSION: These data provide evidence for construct validity of the MISTELS system for urology residents.

A global assessment tool for evaluation of intraoperative laparoscopic skills.

BACKGROUND: There is a pressing need for an intraoperative assessment tool that meets high standards of reliability and validity to use as an outcome measure for different training strategies. The aim of this study was to develop a tool specific for laparoscopic skills and to evaluate its reliability and validity. METHODS: The Global Operative Assessment of Laparoscopic Skills (GOALS) consists of a 5-item global rating scale. A 10-item checklist and 2 visual analogue scales (VAS) for competence and case difficulty were also used. During laparoscopic cholecystectomy, 21 participants were evaluated by the attending surgeon, by 2 trained observers and by self-assessment while dissecting the gallbladder from the liver bed. RESULTS: The intraclass correlation coefficient (ICC) for the total GOALS score was .89 (95% confidence interval [CI] .74 to .95) between observers, .82 (95% CI .67 to .92) between observers and attending surgeons, and .70 (95% CI .37 to .87) between participants and attending surgeons. The ICCs (observers) for the VAS (competence) and the checklist were .69 and .70, respectively. The mean total GOALS score (observers) for novices (postgraduate years [PGYs] 1 through 3) was 13 (95% CI 10.3 to 15.7) compared with 19.4 (95% CI 17.2 to 21.5) for experienced (PGY 4 through attending surgeons, P = .0006). The VAS demonstrated a difference in scores between novice and experienced participants (P = .001); however, the task checklist did not (P = .09). CONCLUSIONS: These data indicate that GOALS is feasible, reliable, and valid. They also suggest that it is superior to the task checklist and VAS for evaluation of technical skill by experienced raters. The findings support the use of GOALS in the training and evaluation of laparoscopic skills.

Proving the value of simulation in laparoscopic surgery.

OBJECTIVE: To assess the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS) physical laparoscopic simulator for construct and predictive validity and for its educational utility. SUMMARY BACKGROUND DATA: MISTELS is the physical simulator incorporated by the Society of American Gastrointestinal and Endoscopic Surgeons (SAGES) in their Fundamentals of Laparoscopic Surgery (FLS) program. MISTELS' metrics have been shown to have high interrater and test-retest reliability and to correlate with skill in animal surgery. METHODS: Over 200 surgeons and trainees from 5 countries were assessed using MISTELS in a series of experiments to assess the validity of the system and to evaluate whether practicing MISTELS basic skills (transferring) would result in skill acquisition transferable to complex laparoscopic tasks (suturing). RESULTS: Face validity was confirmed through questioning 44 experienced laparoscopic surgeons using global rating scales. MISTELS scores increased progressively with increasing laparoscopic experience (n = 215, P < 0.0001), and residents followed over time improved their scores (n = 24, P < 0.0001), evidence of construct validity. Results in the host institution did not differ from 5 beta sites (n = 215, external validity). MISTELS scores correlated with a highly reliable validated intraoperative rating of technical skill during laparoscopic cholecystectomy (n = 19, r = 0.81, P < 0.0004; concurrent validity). Novice laparoscopists were randomized to practice/no practice of the transfer drill for 4 weeks. Improvement in intracorporeal suturing skill was significantly related to practice but not to baseline ability, career goals, or gender (P < 0.001). CONCLUSION: MISTELS is a practical and inexpensive inanimate system developed to teach and measure technical skills in laparoscopy. This system is reliable, valid, and a useful educational tool.

Relationship between objective assessment of technical skills and subjective in-training evaluations in surgical residents.

BACKGROUND: Technical skills of residents have traditionally been evaluated using subjective In-Training Evaluation Reports (ITERs). We have developed the McGill Inanimate System for Training and Evaluation of Laparoscopic Skills (MISTELS), an objective measure of laparoscopic technical ability. The purpose of the study was to assess the concurrent validity of the MISTELS by exploring the relationship between MISTELS score and ITER assessment. STUDY DESIGN: Fifty surgery residents were assessed on the MISTELS system. Concurrent ITER assessments of technical skill were collected, and the proportion of superior ratings for the year was calculated. Statistical comparisons were performed by ANOVA and chi-square analysis. The Pearson correlation coefficient was used to compare the scores in the MISTELS with the ITER ratings. RESULTS: The 50 residents received 277 ITERs for the year, of which 103 (37%) were "superior," 170 (61%) "satisfactory," 4 (1%) "borderline," and 0 "unsatisfactory." The MISTELS score correlated moderately well with the proportion of superior ITER scores (r = 0.51, p < 0.01). Residents who passed the MISTELS had a higher proportion of superior ITER assessments than those who failed the MISTELS (p = 0.02), but residents who performed below their expected level on the MISTELS still received mainly satisfactory ITERs (82 +/- 18%). CONCLUSIONS: The ITER assessment is poor at identifying residents with below-average technical skills. Residents who perform well in the MISTELS laparoscopic simulator also have better ITER evaluations, providing evidence for the concurrent validity of the MISTELS. Multiple assessment instruments are recommended for assessment of technical competency.