Ethical considerations for allocation of scarce resources and alterations in surgical care during a pandemic.

The COVID-19 pandemic caused by SARS-CoV-2 is unprecedented in modern history. Its effects on social behavior and health care delivery have been dramatic. The resultant burden of disease and critical illness has outpaced the diagnostic, therapeutic, and health care professional resources of many clinics and hospitals. It continues to do so globally. The allocation of hospital beds and ventilators, personal protective equipment, investigational therapeutics, and other scarce resources has required difficult decisions. Clinical and surgical practices which are standard in normal times may not be standard or safe during the COVID-19 crisis. How can we best adapt as physicians and surgeons? What foundational ethical principles and systems of principle application can help guide our decision-making? Fortunately, a large body of work in medical ethics addresses these questions. Unfortunately, many surgeons and other health care professionals are probably not as familiar with these concepts. This brief communication is intended to provide a concise explanation of ethical considerations which readers may find helpful when addressing allocation of scarce resources and alterations in surgical care brought on by the current pandemic.

Informed consent: a shared decision-making process that creates a new professional obligation for care.

This statement on informed consent, developed by the SAGES Ethics Committee, has been reviewed and approved by the Board of Governors of SAGES. This statement is provided to offer guidance about the purpose and process of obtaining informed consent, and it is intended for practicing surgeons as well as patients seeking surgical intervention. It is an expression of well-established principles and extensive literature. Excluded from this document are discussions of informed consent for research and informed consent for introduction of new technology, as that has been addressed in previous publications (Strong in Surg Endosc 28:2272, 2014; Stefanidis in Surg Endosc 28:2257, 2014; as reported by Sillin (in: Stain (ed) The SAGES Manual Ethics of Surgical Innovation, Springer, Switzerland, 2016)).

Overproduction of endothelin-1 impairs glucose tolerance but does not promote visceral adipose tissue inflammation or limit metabolic adaptations to exercise.

Endothelin-1 (ET-1) is a potent vasoconstrictor and proinflammatory peptide that is upregulated in obesity. Herein, we tested the hypothesis that ET-1 signaling promotes visceral adipose tissue (AT) inflammation and disrupts glucose homeostasis. We also tested if reduced ET-1 is a required mechanism by which exercise ameliorates AT inflammation and improves glycemic control in obesity. We found that 1) diet-induced obesity, AT inflammation, and glycemic dysregulation were not accompanied by significantly increased levels of ET-1 in AT or circulation in wild-type mice and that endothelial overexpression of ET-1 and consequently increased ET-1 levels did not cause AT inflammation yet impaired glucose tolerance; 2) reduced AT inflammation and improved glucose tolerance with voluntary wheel running was not associated with decreased levels of ET-1 in AT or circulation in obese mice nor did endothelial overexpression of ET-1 impede such exercise-induced metabolic adaptations; 3) chronic pharmacological blockade of ET-1 receptors did not suppress AT inflammation in obese mice but improved glucose tolerance; and 4) in a cohort of human subjects with a wide range of body mass indexes, ET-1 levels in AT, or circulation were not correlated with markers of inflammation in AT. In aggregate, we conclude that ET-1 signaling is not implicated in the development of visceral AT inflammation but promotes glucose intolerance, thus representing an important therapeutic target for glycemic dysregulation in conditions characterized by hyperendothelinemia. Furthermore, we show that the salutary effects of exercise on AT and systemic metabolic function are not contingent on the suppression of ET-1 signaling.

Laparoscopic Dor versus Toupet fundoplication following Heller myotomy for achalasia: results of a multicenter, prospective, randomized-controlled trial.

BACKGROUND: The type of fundoplication that should be performed in conjunction with Heller myotomy for esophageal achalasia is controversial. We prospectively compared anterior fundoplication (Dor) with partial posterior fundoplication (Toupet) in patients undergoing laparoscopic Heller myotomy. METHODS: A multicenter, prospective, randomized-controlled trial was initiated to compare Dor versus Toupet fundoplication after laparoscopic Heller myotomy. Outcome measures were symptomatic GERD scores (0-4, five-point Likert scale questionnaire) and 24-h pH testing at 6-12 months after surgery. Data are mean ± SD. Statistical analysis was by Mann-Whitney U test, Wilcoxon signed rank test, and Freidman's test. RESULTS: Sixty of 85 originally enrolled and randomized patients who underwent 36 Dor and 24 Toupet fundoplications had follow-up data per protocol for analysis. Dor and Toupet groups were similar in age (46.8 vs. 51.7 years) and gender (52.8 vs. 62.5% male). pH studies at 6-12 months in 43 patients (72%: Dor n = 24 and Toupet n = 19) showed total DeMeester scores and % time pH < 4 were not significant between the two groups. Abnormal acid reflux was present in 10 of 24 Dor group patients (41.7%) and in 4 of 19 Toupet patients (21.0%) (p = 0.152). Dysphagia and regurgitation symptom scores improved significantly in both groups compared to preoperative scores. No significant differences in any esophageal symptoms were noted between the two groups preoperatively or at follow-up. SF-36 quality-of-life measures changed significantly from pre- to postoperative for five of ten domains in the Dor group and seven of ten in the Toupet patients (not significant between groups). CONCLUSION: Laparoscopic Heller myotomy provides significant improvement in dysphagia and regurgitation symptoms in achalasia patients regardless of the type of partial fundoplication. Although a higher percentage of patients in the Dor group had abnormal 24-h pH test results compared to those of patients who underwent Toupet, the differences were not statistically significant.

Methylene blue: a simple marker for intraoperative detection of gastroduodenal perforations during laparoscopic pyloromyotomy.

INTRODUCTION: We studied the feasibility of using methylene blue (MB) as a marker to detect mucosal perforations during laparoscopic pyloromyotomy using in vitro and in vivo animal models. MATERIALS AND METHODS: MB was initially tested in pig stomachs in vitro. Information gathered from these experiments was then used to test the marker during experimental live piglet laparoscopic surgery. RESULTS: MB stained the gastric mucosa blue; this tint could be seen through the intact mucosal layer exposed via myotomy. Dye extravasation was seen during laparoscopic surgery with mucosal perforations of 1.2 mm and greater with or without air insufflation of the stomach. Air extravasation was seen with perforations of 2.0 mm and greater. CONCLUSION: Full strength 1% MB dye instilled into the gastric lumen can potentially be used as a marker for detection of mucosal perforations of 1.2 mm or greater during laparoscopic pyloromyotomy.

Practice makes perfect: progressive improvement of laparoscopic pyloromyotomy results, with experience.

INTRODUCTION: Pyloric stenosis can now be treated effectively with laparoscopic pyloromyotomy (LP). Few large outcome studies have been published regarding the laparoscopic technique. In this paper, we describe our experience with the first 185 consecutive LPs. MATERIALS AND METHODS: An institutional review board-approved retrospective outcomes analysis was performed on our first 185 consecutive LPs. Previous publications comparing open pyloromyotomy (OP) and LP are reviewed. Our hypothesis is that, with experience, the outcome of LP will equal or surpass that of OP. RESULTS: A total 185 infants underwent LPs during the study period. The infants had median values of age: 33 days; body weight: 4 kg; surgery duration: 25 minutes; postoperative length of stay (LOS): 25.5 hours; and total LOS: 45 hours. There were 7 complications (3.78%): 4 incomplete pyloromyotomies (2.2%), 1 pyloric mucosal perforation (0.5%), 1 delayed duodenal perforation (0.5%), and 1 wound infection (0.5%). There has been a progressive reduction in the time required for surgery, from a median of 29 minutes in the first 60 cases to 21.5 in the last 65. Postoperative LOS has fallen from a median of 26 hours in the first half to 24.5 in the later half. Complications occurred primarily in the first third of our cases. CONCLUSIONS: We are able to demonstrate that, with experience, one can expect progressive improvement in the outcomes following LP in infants. Our surgery duration and complications in the last 65 cases are better than most published results for OP or LP.

Finding Them a Spot: A Successful Preliminary Match Curriculum.

PURPOSE: Nondesignated preliminary residents (N-DPRs) in General Surgery face difficult challenges of overcoming failure to match and quickly reentering the match again with little time to significantly improve their application. Programs with N-DPRs should take seriously their responsibility for helping these residents obtain a successful career path just as they do for their categorical residents. This study evaluates an intervention to improve the matching of N-DPRs into desired positions. METHODS: We evaluated the match results of N-DPRs at a single institution over an 8-year period. The first 4 years served as the historical control (Group 1), while the following 4 years of N-DPRs underwent a focused intervention (Group 2). Group 2 underwent an 8-step process: (1) a phone call shortly after supplemental offer and acceptance program (SOAP) to discuss strategy, (2) a 1-hour N-DPR specific orientation, (3) targeted meetings to identify reasons for an unsuccessful match, and personal statement revision in July, (4) mock interviews in August, (5) mid-interview cycle meetings to review strategy and trajectory, (6) meetings in January to prioritize rank lists, (7) meetings the week before the match to discuss plan if match is unsuccessful, and (8) meeting on Monday of Match Week. We determined the N-DPRs initial choice of specialty, specialty obtained after their N-DPR year, and career choice changes that occurred during their preliminary years for both groups. Comparisons and statistical analysis were then completed. RESULTS: There were 40 N-DPRs in the program over the last 8 years. Group 1, the 4 years before the curriculum, had only 13 of the 16 (81%) N-DPRs obtain a desired position. Group 2, the 4 years following intervention, had all 24 (100%) N-DPRs obtain a desired position. This was a significant improvement (number needed to treat (NNT) = 5.38, p = 0.027). There were no significant differences between groups in regard to the N-DPRs maintaining their original specialty of choice (44% vs 50%). CONCLUSIONS: The implementation of an N-DPR curriculum significantly improved the probability of N-DPRs to obtain desired positions. Over half of the N-DPRs obtained a position in a specialty different from what they originally applied. Programs should consider aiding N-DPRs in navigating toward a different career path.

Development and evaluation of standardized narrative cases depicting the general surgery professionalism milestones.

PURPOSE: Residency programs now are required to use educational milestones, which has led to the need for new methods of assessment. The literature suggests that narrative cases are a promising tool to track residents' progress. This study demonstrates the process for developing and evaluating narrative cases representing the five levels of the professionalism milestones. METHOD: In 2013, the authors identified 28 behaviors in the Accreditation Council for Graduate Medical Education general surgery professionalism milestones. They modified previously published narrative cases to fit these behaviors. To evaluate the quality of these cases, the authors developed a 28-item, five-point scale instrument, which 29 interdisciplinary faculty completed. The authors compared the faculty ratings by narrative case and specialty with the authors' initial rankings of the cases by milestone level. They used t tests and analysis of variance to compare mean scores across specialties. RESULTS: The authors developed 10 narrative cases, 2 for each of the 5 milestone levels. Each case contained at least 20 of the 28 behaviors identified in the milestones. Mean faculty ratings matched the milestone levels. Reliability was good (G coefficient = 0.86, phi coefficient = 0.85), indicating consistency in raters' ability to determine the proper milestone level for each case. CONCLUSIONS: The authors demonstrate a process for using specialty-specific milestones to develop narrative cases that map to a spectrum of professionalism behaviors. This process can be applied to other competencies and specialties to facilitate faculty awareness of resident performance descriptors and provide a frame of reference for milestones assessment.

Characterizing information decay in patient handoffs.

OBJECTIVE: The purpose of this study was to analyze the decay of information with multiple sequential patient handoff reports given by third-year medical students who have not had standardized patient handoff training. METHODS: We examine the information decay of quantitative parameters included in 2 different simulated patient history and physical handoffs conducted among third-year medical students. Both student self-surveys and third party observer surveys tracked accuracy of information. A total of 93 students were surveyed for the first patient scenario and 103 students were surveyed for second patient scenario. Survey data were aggregated into 2 separate spreadsheets, one for each patient scenario tested. A total of 16 data points pertaining to the checklist were analyzed for common trends in handoff accuracy and information decay. RESULTS: Quantitative analysis of information passed between handoffs showed that between the 2 case scenarios, there was a consistent loss of information between one presenter to the next. Overall, 33% of information was lost between the first and third handoffs. Within the progression of individual handoffs, a narrative decay was demonstrated. There was a regression in handoff accuracy, trending down to an average of only 45% of information being passed on successfully by the time each presenter reached the last piece of information in their patient presentation. When examining the survey data points that had greater than an 80% success rate of being included in the handoffs, there appeared to be no correlation between their inherent qualities. CONCLUSIONS: This study showed there is a significant decrease in accuracy of information during sequential patient handoff exercises. The information decay may be a result of time, memory, or relevance of the information to the student. Future studies incorporating teaching effective handoffs early in the clinical curriculum would be an area of future research.

Single-incision laparoscopic cholecystectomy: initial experience with critical view of safety dissection and routine intraoperative cholangiography.

BACKGROUND: Single-incision laparoscopic cholecystectomy (SILC) is emerging as a potentially less invasive alternative to standard laparoscopic cholecystectomy and natural orifice transluminal endoscopic surgery cholecystectomy. As this technique is more widely used, it is important to maintain well-established practices of the critical view of safety (CVS) dissection and intraoperative cholangiography (IOC). We present our initial experience with SILC using CVS dissection and routine IOC. STUDY DESIGN: Fifty-four patients with biliary colic were offered SILC, which was performed through the umbilicus. CVS with photo documentation was attained before clipping and transecting the cystic structures. IOC was done using various needle puncture techniques. Assessment of CVS was carried out by independent surgeon review of operative still photos or videos using a 3-point grading scale: visualization of only 2 ductal structures entering the gallbladder; a clear triangle of Calot; and separation of the base of the gallbladder from the cystic plate. RESULTS: SILC was performed in 54 patients (15 male and 39 female). Six patients required 1 supplementary 3- or 5-mm port. Complete IOC was successful in 50 of 54 patients (92.6%). CVS was achieved at the time of operation in all 54 patients. Photo documentation review confirmed 3 of 3 CVS criteria in 32 (64%) patients, 2 of 3 in 12 patients (24%), 1 of 3 in 3 patients (6%), and 0 in 3 patients (6%). CONCLUSIONS: As laparoscopic cholecystectomy becomes less invasive, proven safe dissection techniques should be maintained. Dissection to obtain the CVS should be the goal of every patient and IOC can be accomplished in a high percentage of patients. This approach places patient safety considerations foremost in the evolution of minimally invasive cholecystectomy.

Robot-assisted laparoscopic colectomy: 70 cases-one surgeon.

This study reviewed the use of robot-assisted laparoscopic surgery for colon resection. We described the six-year experience of one minimally invasive fellowship-trained surgeon performing 70 consecutive colectomies using the da Vinci system. Between September 2002 and 2007, data on 70 patients undergoing robotic colectomy for diverticular disease, polyps, cancer, or carcinoid tumor were collected. Operations were right colectomy and sigmoid colectomy. A total of 38 right and 32 sigmoid colectomies were performed in 32 males and 38 females. The postoperative diagnoses were diverticular disease (19), polyps (36), cancer (13), and carcinoid (2). Times for the right colectomies were: port setup time 33.6 ± 12.1 (20-64) min, robotic time 147.2 ± 44.4 (53-306) min, and total case time 221.3 ± 43.7 (150-380) min. The estimated blood loss (EBL) was 53.9 ± 78.2 (15-500) ml, the body mass index (BMI) 27.2 ± 4.2 (17-36.8) kg/m(2), and the median length of stay (LOS) 3 (2-27) days. The robotic portion represented 66.5 % of the total case time. Times for the sigmoid colectomies were: port setup time 30.0 ± 9.8 (10-57) min, robotic time 101.8 ± 25.3 (67-165) min, and total case time 228.4 ± 40.5 (147-323) min. The EBL was 71.2 ± 47.9 (15-200) ml, the BMI 27.1 ± 4.9 (17.0-40.5) kg/m(2), and the median LOS 4 (2-27) days. The robotic portion represented 44.6% of the total case time. Eight different types of complication occurred. Eight cases were converted-five to open and three to laparoscopic. Two resulted from robot malfunction. Residents participated in 40 cases (57.1%). In the years 2002-2006, respectively, 5, 12, 10, 11, and 19 robotic colectomies were performed. In the first nine months of 2007, 13 robotic colectomies were performed. These 70 consecutive cases have demonstrated robotic colectomy to be a safe and technically feasible approach. The number of robotic colectomies performed each year has steadily increased over the last six years. This series compared favorably with other robotic series in length of hospital stay, conversion rates, and total case time.

Placement of a covered polyester stent prevents complications from a colorectal anastomotic leak and supports healing: randomized controlled trial in a large animal model.

BACKGROUND: Anastomotic leaks after colorectal operation continue to be a significant cause of morbidity. A covered endoluminal stent could seal a leak and eliminate the need for diversion. The aim of this study was to test the efficacy of a temporary covered stent to prevent leak related complications. METHODS: Sixteen adult pigs (80-120 lbs) underwent open transection of the rectosigmoid followed by anastomosis with a circular stapler. Eight animals (study group) underwent endoscopic placement of a 21-mm covered polyester stent. Eight control group animals were left without stents. In all animals, a 2-cm leak was created along the anterior portion of the anastomosis. The animals were killed after 2 weeks and evaluated for abdominal infection, fistulae, and adhesions. The anastomosis was excised and the following parameters were assessed by a pathologist blinded to treatment: mucosal interruption (mm), inflammatory response, collagen type I and III, granulation, and fibrosis (grade 0-4). RESULTS: Stents were spontaneously expelled between postoperative days 6 and 9. At necropsy, none of the animals in the study group had leak related complications, whereas in the control group, 5 (63%) developed intraabdominal infection (4 abscesses, 1 fistula) at the anastomosis (P = .002). Dense adhesions to the anastomosis were found in 7 (88%) control animals. On histology, anastomotic sites in the study group had significantly less mucosal interruption and granulation. Two pigs in the study group died on postoperative day 7, one due to evisceration and one from bladder necrosis. The mortality result is not different from controls (P = .47), both events seem to be unrelated to stent placement. CONCLUSION: Temporary placement of a covered polyester stent across a colorectal anastomosis prevents leak-related complications and supports the healing of anastomotic leaks.