A randomized, double-blinded, placebo-controlled trial of the effects of infusing local analgesia on post-operative pain during laparoscopic inguinal hernia repair.

PURPOSE: While it is widely accepted that laparoscopic total extraperitoneal (TEP) inguinal herniorrhaphy has decreased post-operative pain, there are conflicting data as to whether instillation of local anesthetic into the preperitoneal space improves post-operative pain in these patients. We designed a prospective study to evaluate this. Secondary outcomes include time spent in the PACU, need for narcotic pain medication, and total amount of narcotics required postoperatively. METHODS: Prospective, randomized, double-blind, placebo-controlled study which enrolled 70 patients with unilateral non-recurrent inguinal hernia from 09/2013 to 03/2019 and included immediate and 2-week post-operative follow-up. All patients received unilateral laparoscopic TEP inguinal hernia repair with control patients receiving 10 ml of 0.9% saline instilled into preperitoneal space while treatment group received 10-ml 0.5% bupivacaine without epinephrine. RESULTS: A total of 70 patients [67 (96%) men and 3 women; mean age (SD), 57 years (13.8)] were enrolled, 35 randomized into each group. Demographics between the two groups were similar. No differences were found in post-operative pain between the control and test groups at 1 h [mean (SD) of 3.15(2.5) vs 3.21(2.9); P = 0.92], 2 h [3.39 (1.55) vs 2.74 (1.85) P = 0.18], or 1 day [4.79 (2.19) vs 4.39 (2.37); P = 0.13] postoperatively. Likewise, no significant differences were observed in usage of narcotic pain medication postoperatively, as 17 control patients (50%) and 16 (46%) study patients required narcotics within 2 h of surgery (P = 0.72). CONCLUSION: Instilling local anesthetic into the preperitoneal space during laparoscopic TEP inguinal hernia repair did not result in statistically significant difference in post-operative pain (Rade et al. in NESS Annual Meeting, 2021). Trial registry ClinicalTrials.gov Identifier: NCT02055053.

Injury Characteristics and Outcomes of Patients With Inflammatory Bowel Disease After Trauma: A Propensity Score Matched Analysis.

BACKGROUND: The clinical course of patients with inflammatory bowel disease (IBD) after trauma is largely unknown. We sought to compare the clinical course of patients with IBD to those without. METHODS: We conducted a retrospective case-control study of adult patients admitted to a level-1 trauma center from January 1, 2008, through October 1, 2015. Seventy-five patients with IBD were identified. Cases were matched to controls by age, sex, injury severity, and mechanism using 4:1 propensity score-matching analysis. Injury characteristics, clinical course, and infectious and noninfectious complications were compared using bivariate and multivariate analysis. RESULTS: Participants had a mean age of 56 years and mean injury severity score of 15. Of the 75 cases, 44% had ulcerative colitis, 44% had Crohn's disease, and 12% had undetermined type. More cases were on an immunosuppressant (19% vs 2%, P < 0.01) or steroids (8% vs 2%, P = 0.02) on admission compared with controls. More cases had prior abdominal surgery (P = 0.01). Cases had fewer brain injuries (P = 0.02) and higher admission Glasgow Coma Scale (P < 0.01) but required more neurosurgical intervention (P = 0.03). Cases required more orthopedic surgeries (P < 0.01) and more pain management consultations (P = 0.04). In multivariable analysis, IBD was associated with increased odds of operative intervention, pain management consultation, venous thromboembolism, and longer hospital stay (P < 0.05). Patients on immunosuppressants had increased odds of requiring surgery (P = 0.04), particularly orthopedic surgery (P < 0.01). CONCLUSIONS: Baseline factors associated with inflammatory bowel disease may place patients at higher risk for surgery and complications after trauma.

Overuse and Limited Benefit of Chemotherapy for Stage II Colon Cancer in Young Patients.

BACKGROUND: Few studies have confirmed a benefit for adjuvant chemotherapy (aCTX) in stage II colon cancer. We used the National Cancer Database to explore the use and efficacy of aCTX in patients with both normal-risk (NR) and high-risk (HR) young stage II colon cancer. PATIENTS AND METHODS: We identified patients with stage II colon cancer who underwent colectomy between 2010 and 2015. HR patients included at least: lymphovascular or perineural invasion, < 12 lymph nodes, poor/un-differentiation, T4, or positive margins. Rates of aCTX by age and risk were calculated, and adjusted factors associated with aCTX were identified. Overall survival was estimated using the Kaplan-Meier method and Cox multivariable analyses for patients < 50 years. RESULTS: Among the 81,066 stage II patients who underwent colectomy, 6093 (7.5%) were < 50 years old. Of these, 2669 patients were HR. Thirty percent of NR and almost 60% of HR patients < 50 years received aCTX, compared with 8% and 23% of patients > 50 years (P < .001). In NR patients < 50 years, 35.3% with microsatellite-stable tumors and 18% with microsatellite unstable tumors received aCTX (P < .001), whereas 63.6% and 43.2%, respectively, of HR patients did (P < .001). The most significant multivariable predictors of aCTX were risk status and age. On univariate analysis, there was no survival benefit associated with aCTX in patients < 50 years. Multivariate analysis failed to demonstrate a survival benefit for aCTX for either group (HR, 0.97; P = .84; NR, 0.1.03; P = .90). CONCLUSION: Young patients with HR and NR colon cancer received aCXT more frequently than older patients with no demonstrable survival benefit. This bears further evaluation to avoid the real risks of over-treatment in this increasing population.

Elective colon resection without curative intent in stage IV colon cancer.

BACKGROUND: Evidence suggests that elective primary colon resection (ePCR) in patients with asymptomatic colon tumors and unresectable metastases is not required and may expose patients to unnecessary operative risk. METHODS: Stage IV colon cancer patients with liver metastases from 2000 to 2011 were identified with SEER-Medicare data. Liver-based therapy or urgent/emergent colectomies were excluded. Chemotherapy alone was compared to ePCR ±â€¯chemotherapy. Univariate and multivariate analyses were used to identify predictors of ePCR. Multivariate Cox regression compared survival. RESULTS: 5139 patients were identified. The ePCR rate decreased over time; 84% underwent ePCR in 2000, compared to 52% in 2011 (p < 0.001). In multivariate analysis, older patients were more likely to undergo ePCR, as were patients from rural areas (OR 1.65, p < 0.001). The odds of PCR in high poverty areas (>10%) were almost 25% higher than those in low poverty areas (OR 1.23, p = 0.03). African-Americana were less likely to undergo PCR than Caucasians (OR 0.76, p = 0.01). In multivariate survival analysis, PCR was associated with a significant survival benefit (HR 0.59, p < 0.001). CONCLUSIONS: Although ePCR is not recommended with unresectable metastases and the rate has decreased significantly, over 50% of patients with untreated hepatic metastases underwent ePCR in 2011. Disparities exist in use of ePCR that are likely multifactorial and deserve further study.

Advanced laparoscopic skills: Understanding the relationship between simulation-based practice and clinical performance.

INTRODUCTION: The advanced laparoscopic skills (ALS) curriculum was created to address the need for improved laparoscopic training for senior surgical trainees. It focuses on the domain of laparoscopic suturing and consists of 6 tasks with established proficiency benchmarks. Tasks are performed using a standard laparoscopic box trainer. This study examines whether practicing on the ALS curriculum could translate to improved clinical suturing. METHODS: Surgery residents from four institutions participated in the study. Performance of the 6 ALS tasks and performance of a porcine gastrojejunostomy (GJ) and Nissen fundoplication were assessed before and after training. Video-recorded performance was de-identified and scored by three experts using both time and a previously published assessment instrument. Paired t-tests examined performance differences before and after the curriculum. Pearson correlations examined the relationship between performance on the porcine and ALS tasks. RESULTS: Twelve residents (PGY1-8) from 4 institutions completed the study. Average practice time on ALS tasks was 6.25 weeks (range 1-14 weeks) and 254 min (range 140-600min). Combined ALS task time decreased from 2748s ±â€¯603s to 1756s ±â€¯281s (p < 0.001). Each of the 6 task times significantly improved (p < 0.05). Total errors decreased from 5.8 ±â€¯3.2 to 3.7 ±â€¯1.9 (p < 0.05). Average GJ times decreased from 1043s ±â€¯698s to 643s ±â€¯183s (p = 0.055). Average Nissen times decreased from 990s ±â€¯531s to 685s ±â€¯265s (p < 0.05). CONCLUSION: Dedicated practice on the six ALS tasks led to decreased suturing time and fewer errors when completing both GJ and Nissen suturing in a porcine model. Further studies will be undertaken to determine the optimal application of the ALS task set in advanced laparoscopic training.

Multicenter proficiency benchmarks for advanced laparoscopic suturing tasks.

BACKGROUND: Advanced laparoscopic suturing (LS) tasks were developed based on a needs assessment. Initial validity evidence has been shown. The purpose of this multicenter study was to determine expert proficiency benchmarks for these tasks. METHODS: 6 tasks were included: needle handling (NH), offset-camera forehand suturing (OF), offset-camera backhand suturing (OB), confined space suturing (CF), suturing under tension (UT), and continuous suturing (CS). Minimally invasive surgeons experienced in LS completed the tasks twice. Mean time and median accuracy scores were used to establish the benchmarks. RESULTS: Seventeen MIS surgeons enrolled, from 7 academic centers. Mean (95% CI) time in seconds to complete each task was: NH 169 (149-189), OF 158 (134-181), OB 189 (154-224), CF 181 (156-205), UT 379 (334-423), and CS 416 (354-477). Very few errors in accuracy were made by experts in each of the tasks. CONCLUSIONS: Time- and accuracy-based proficiency benchmarks for 6 advanced LS tasks were established. These benchmarks will be included in an advanced laparoscopic surgery curriculum currently under development.

Evaluation of advanced laparoscopic skills tasks for validity evidence.

BACKGROUND: Since fundamentals of laparoscopic surgery (FLS) represents a minimum proficiency standard for laparoscopic surgery, more advanced proficiency standards are required to address the needs of current surgical training. We wanted to evaluate the acceptance and discriminative ability of a novel set of skills building on the FLS model that could represent a more advanced proficiency standard-advanced laparoscopic surgery (ALS). METHODS: Qualitative and quantitative analyses were employed. Quantitative analysis involved comparison of expert (PGY 5+), intermediate (PGY 3-4) and novice (PGY 1-2) surgeons on FLS and ALS tasks. Composite scores included time and errors. Standard FLS errors were added to task time to create the composite score. Qualitative analysis involved thematic review of open-ended questions provided to experts participating in the study. RESULTS: Out of 48 participants, there were 15 (31 %) attendings, 3 (6 %) fellows and 30 (63 %) residents. By specialty, 54 % were general/MIS/bariatric/colorectal (GMBC) and 46 % were other (urology and gynecology). There was no difference between experience level and performance on FLS and ALS tasks for the entire cohort. However, looking at the GMBC subgroup, experts performed better than novices (p = 0.012) and intermediates performed better than novices (p = 0.057) on ALS tasks. There was no difference for the same group in FLS performance. Also, GMBC subgroup performed significantly better on FLS (p = 0.0035) and ALS (p = 0.0027) than the other subgroup. Thematic analysis revealed that the majority of experts felt that ALS was more realistic, challenging and clinically relevant for specific situations compared to FLS. CONCLUSION: For GMBC surgeons, we were able to show evidence of validity for a series of advanced laparoscopic tasks and their relationship to surgeon skill level. This study may represent the first step in the development of an advanced laparoscopic skills curriculum. Given the high degree of specialization in surgery, different advanced skills curricula will need to be developed for each specialty.

Staging laparoscopy in pancreatic cancer: a potential role for advanced laparoscopic techniques.

BACKGROUND: The role of staging laparoscopy in pancreatic cancer in the age of high-resolution CT scans is under debate. This study's aim is to evaluate the efficacy of staging laparoscopy in this disease. STUDY DESIGN: A retrospective cohort study was conducted evaluating patients who underwent operative treatment for radiographic stage I to III pancreatic cancer between July 2003 and October 2012. Radiographic follow-up was 94% at 6 months. RESULTS: Of 274 patients who met inclusion criteria, 136 underwent staging laparoscopy, which identified radiographic occult distant metastases in 2% (3 of 136). However, subsequent laparotomy identified an additional 9% (12 of 136) harboring distant metastases in regions not visualized on standard staging laparoscopy; specifically, the posterior liver surface, paraduodenal retroperitoneum, proximal jejunal mesentery, and lesser sac. The remaining 138 patients underwent initial staging laparotomy, which showed similar results identifying radiographic occult distant disease in 11% (15 of 138). Within 6 months after the operation, peritoneal or subcapsular liver metastases developed in an additional 6% (15 of 257)-disease that potentially could have been diagnosed at the time of operation-providing a false-negative rate of 88% for staging laparoscopy compared with 36% for staging laparotomy. CONCLUSIONS: Despite the availability of high-resolution CT scans, occult distant metastases can still be found in 11% of patients during the operation. In the absence of reliable risk factors to predict distant metastases, staging laparoscopy should be offered to all patients with radiographic localized disease. However, the results favor extended laparoscopic staging with evaluation of the posterior liver surface, mobilization of the duodenum, evaluation of the proximal jejunal mesentery, and visualization of the lesser sac.

Multidetector CT coronary angiography for patient triage to invasive coronary angiography: Performance and cost in ambulatory patients with equivocal or suspected inaccurate noninvasive stress tests.

BACKGROUND: Multidetector-CT angiography (MDCTA) differs from noninvasive stress tests by directly imaging coronary anatomy. The utility of MDCTA for invasive triage is undefined however. We evaluated MDCTA triage to invasive coronary angiography in outpatients with indeterminate or suspected inaccurate stress tests, and estimated cost savings by MDCTA in this role. METHODS: Consecutive MDCTA patients were retrospectively compared with noninvasive stress tests if performed within 6 months of MDCTA. Twelve-month clinical follow up was obtained for patients not undergoing invasive angiography, and cost using MDCTA for triage to invasive coronary angiography was calculated. RESULTS: MDCTA was performed in 385 patients who had noninvasive stress testing. Stress tests include included treadmill (n = 37), stress echo (n = 178), and nuclear perfusion imaging (n = 170). Invasive angiography was performed in 57 (14.8%). MDCTA compared to CA showed positive and negative predictive values of 94%/100% respectively for lesions found by invasive QCA. Stress testing compared to MDCTA showed positive/negative predictive values of 100%/67% for treadmill exercise, 60%/54% for stress echo, and 59%/55% of nuclear perfusion examinations respectively. One year clinical follow up in 314 patients showed no coronary events in 98% (309) of patients. Triage to invasive angiography by MDCTA showed a 4-fold cost reduction. CONCLUSIONS: MDCTA shows excellent performance as a triage for invasive angiography in patients with stress tests that are equivocal or thought inaccurate. A negative CTA confers good 12-month prognosis. Substantial cost savings may accrue using MDCTA in this triage role.