Malpractice Claims Following Major Liver and Pancreatic Surgeries: What Can we Learn?

INTRODUCTION: General surgery is a highly litigious specialty. Lawsuits can be a source of emotional distress and burnout for surgeons. Major hepatic and pancreatic surgeries are technically challenging general surgical oncology procedures associated with an increased risk of complications and mortality. It is unclear whether these operations are associated with an increased risk of lawsuits. The objective of the present study was to summarize the medical malpractice claims surrounding pancreatic and hepatic surgeries from publicly available court records. METHODS: The Westlaw legal database was searched and analyzed for relevant malpractice claims from the last two decades. RESULTS: Of 165 search results, 30 (18.2%) cases were eligible for inclusion. Appellant cases comprised 53.3% of them. Half involved a patient death. Including co-defendants, a majority (n = 21, 70%) named surgeons as defendants, whereas several claims (n = 13, 43%) also named non-surgeons. The most common cause of alleged malpractice was a delay in diagnosis (n = 12, 40%). In eight of these, surgery could not be performed. The second most common were claims alleging the follow-up surgery was due to negligence (n = 6). Collectively, 20 claims were found in favor of the defendant. Seven verdicts (23.3%) returned in favor of the plaintiff, two of which resulted in monetary awards (totaling $1,608,325 and $424,933.85). Three cases went to trial or delayed motion for summary judgment. There were no settlements. CONCLUSIONS: A defendant verdict was reached in two-thirds of malpractice cases involving major hepatic or pancreatic surgery. A delay in diagnosis was the most cited claim in hepatopancreaticobiliary lawsuits, and defendants may often practice in nonsurgical specialties. While rulings favoring plaintiffs are less frequent, the payouts may be substantial.

Probiotic Supplementation for Promotion of Growth in Undernourished Children: A Systematic Review and Meta-Analysis.

OBJECTIVES: Probiotic supplementation has been proposed as a therapeutic intervention to improve growth outcomes in children with undernutrition. The objective of this review is to synthesize the current evidence on probiotic supplementation for promotion of growth in undernourished children. METHODS: We searched MEDLINE, Cochrane CENTRAL, CINAHL, Embase, LILACS, and Scopus for randomized controlled trials (RCTs) that administered probiotics or eligible comparators to undernourished children below 5 years of age. Our primary outcomes of interest were weight-for-age, height-for-age, and weight-for-height at the longest follow-up points reported. Random-effects meta-analysis was used to calculate standardized mean differences (SMD) for continuous outcomes and risk ratios for dichotomous outcomes. The Grading of Recommendations Assessment, Development and Evaluation criteria were used to assess certainty of the evidence. RESULTS: Nine RCTs with 5295 children in total were included. Durations of treatment ranged from 1 month to 1 year. Pooled analyses from 7 studies showed that probiotics may have little to no effect on weight-for-age (SMD 0.05 standard deviation [SD], 95% CI: -0.04 to 0.13, n = 2115 children; low-certainty evidence) and height-for-age (SMD -0.04 SD, 95% CI: -0.14 to 0.07, n = 1357 children; low-certainty evidence). The evidence was very uncertain about the effect on weight-for-height. CONCLUSIONS: Probiotics may have little to no effect on anthropometry in undernourished children, though there is considerable heterogeneity among the trials reviewed thus far. The interaction between gut microbiota and human nutrition is complex, and further research is needed to determine how the gut microbiome may contribute to undernutrition and how probiotics may affect growth in this vulnerable population.

Long-term Recurrence Rates After Surgery in Primary Hyperparathyroidism.

CONTEXT: Primary hyperparathyroidism (PHPT) is the most common cause of hypercalcemia, yet long-term (5- and 10-year) recurrence rates after curative surgery have been unclear. OBJECTIVE: To perform the first systematic review and meta-analysis investigating the long-term recurrence rates of sporadic PHPT after successful parathyroidectomy. METHODS: A comprehensive search of multiple databases (including PubMed, EMBASE, Cochrane, EBSCO-CINHAL, EMBASE, Ovid, Scopus, and Google Scholar) was performed from each database's inception to January 18, 2023. Observational studies reporting at least 5 years of follow-up data after surgical resection were included. Two reviewers independently screened articles for relevance. Of 5769 articles initially identified, 242 were examined in full-text review and 34 were deemed eligible for inclusion. Two authors independently performed data extraction and study appraisal, using the National Institutes of Health study quality assessment tools. RESULTS: Of 30 658 participants, 350 patients (1.1%) experienced recurrence after resection. A meta-analysis of proportions was performed to obtain the pooled recurrence rates. The pooled estimate for overall recurrence rate was 1.56% (95% CI 0.96-2.28%; I2 = 91%). The pooled estimates for 5- and 10-year recurrence rate after resection were 0.23% (0.04-0.53%, 19 studies; I2 = 66%) and 1.03% (0.45-1.80%, 14 studies; I2 = 89%), respectively. Sensitivity analyses did not find a statistically significant difference when adjusting for study size, diagnosis, or surgical approach. CONCLUSION: Approximately 1.56% of sporadic PHPT patients eventually develop recurrence following parathyroidectomy. The initial diagnosis and procedure type does not influence recurrence rates. Consistent long-term follow-up is warranted to help identify recurrent disease.

Chylous Ascites After Robot-Assisted Laparoscopic Donor Nephrectomy: Is Early Surgical Intervention Necessary?

OBJECTIVES: Chylous ascites is a rare complication that may occur after living donor nephrectomy. The continuous loss of lymphatics, which carries a high risk of morbidity, may ensue in possible immunodeficiency and protein-calorie malnutrition. Here, we presented patients who developed chylous ascites after robotassisted living donor nephrectomy and reviewed the current literature of therapeutic strategies for chylous ascites. MATERIALS AND METHODS: We reviewed the medical records of 424 laparoscopic living donor nephrectomies performed at a single transplant center; among these, we studied the records of 3 patients who developed chylous ascites following robot-assisted living donor nephrectomy. RESULTS: Among 438 living donor nephrectomies, 359 (81.9%) were laparoscopic and 77 (18.1%) were by robotic assistance. In the 3 cases highlighted in our study, patient 1 did not respond to conservative therapy, which consisted of diet optimization, total parenteral nutrition, and octreotide (somatostatin). Patient 1 subsequently underwent robotic-assisted laparoscopy with suture ligation and clipping of leaking lymphatic vessels, allowing the chylous ascites to subside. Patient 2 similarly did not respond to conservative treatment and developed ascites. Despite initial improvement after wound interrogation and drainage, patient 2 had continued symptoms, resulting in diagnostic laparoscopy and repair of leaky channels leading to the cisterna chyli. Patient 3 developed chylous ascites 4 weeks postoperatively and received ultrasonographic-guided paracentesis by interventional radiology, with results showing an aspirate consistent with chyle. The patient's diet was optimized, allowing for initial improvement and eventual return to normal diet. CONCLUSIONS: Our case series and literature review demonstrate the importance of early surgical intervention after failed conservative management for resolution of chylous ascites in patients after robotassisted donor laparoscopic nephrectomy.

Fecal transplantation for treatment of inflammatory bowel disease.

BACKGROUND: Inflammatory bowel disease (IBD) is a chronic, relapsing disease of the gastrointestinal (GI) tract that is thought to be associated with a complex interplay between the immune system, the GI tract lining, the environment, and the gut microbiome, leading to an abnormal inflammatory response in genetically susceptible individuals. An altered composition of the gut's native microbiota, known as dysbiosis, may have a major role in the pathogenesis of ulcerative colitis (UC) and Crohn disease (CD), two subtypes of IBD. There is growing interest in the correction of this underlying dysbiosis using fecal microbiota transplantation (FMT). OBJECTIVES: To evaluate the benefits and safety profile of FMT for treatment of IBD in adults and children versus autologous FMT, placebo, standard medication, or no intervention. SEARCH METHODS: We searched CENTRAL, MEDLINE, Embase, two clinical trial registries, and the reference sections of published trials through 22 December 2022. SELECTION CRITERIA: We included randomized controlled trials that studied adults and children with UC or CD. Eligible intervention arms used FMT, defined as the delivery of healthy donor stool containing gut microbiota to a recipient's GI tract, to treat UC or CD. DATA COLLECTION AND ANALYSIS: Two review authors independently screened studies for inclusion. Our primary outcomes were: 1. induction of clinical remission, 2. maintenance of clinical remission, and 3. serious adverse events. Our secondary outcomes were: 4. any adverse events, 5. endoscopic remission, 6. quality of life, 7. clinical response, 8. endoscopic response, 9. withdrawals, 10. inflammatory markers, and 11. microbiome outcomes. We used the GRADE approach to assess the certainty of evidence. MAIN RESULTS: We included 12 studies with 550 participants. Three studies were conducted in Australia; two in Canada; and one in each of the following: China, the Czech Republic, France, India, the Netherlands, and the USA. One study was conducted in both Israel and Italy. FMT was administered in the form of capsules or suspensions and delivered by mouth, nasoduodenal tube, enema, or colonoscopy. One study delivered FMT by both oral capsules and colonoscopy. Six studies were at overall low risk of bias, while the others had either unclear or high risk of bias. Ten studies with 468 participants, of which nine studies focused on adults and one focused on children, reported induction of clinical remission in people with UC at longest follow-up (range 6 to 12 weeks) and showed that FMT may increase rates of induction of clinical remission in UC compared to control (risk ratio (RR) 1.79, 95% confidence interval (CI) 1.13 to 2.84; low-certainty evidence). Five studies showed that FMT may increase rates of induction of endoscopic remission in UC at longest follow-up (range 8 to 12 weeks); however, the CIs around the summary estimate were wide and included a possible null effect (RR 1.45, 95% CI 0.64 to 3.29; low-certainty evidence). Nine studies with 417 participants showed that FMT may result in little to no difference in rates of any adverse events (RR 0.99, 95% CI 0.85 to 1.16; low-certainty evidence). The evidence was very uncertain about the risk of serious adverse events (RR 1.77, 95% CI 0.88 to 3.55; very low-certainty evidence) and improvement in quality of life (mean difference (MD) 15.34, 95% CI -3.84 to 34.52; very low-certainty evidence) when FMT was used to induce remission in UC. Two studies, of which one also contributed data for induction of remission in active UC, assessed maintenance of remission in people with controlled UC at longest follow-up (range 48 to 56 weeks). The evidence was very uncertain about the use of FMT for maintenance of clinical remission (RR 2.97, 95% CI 0.26 to 34.42; very low-certainty evidence) and endoscopic remission (RR 3.28, 95% CI 0.73 to 14.74; very low-certainty evidence). The evidence was also very uncertain about the risk of serious adverse events, risk of any adverse events, and improvement in quality of life when FMT was used to maintain remission in UC. None of the included studies assessed use of FMT for induction of remission in people with CD. One study with 21 participants reported data on FMT for maintenance of remission in people with CD. The evidence was very uncertain about the use of FMT for maintenance of clinical remission in CD at 24 weeks (RR 1.21, 95% CI 0.36 to 4.14; very low-certainty evidence). The evidence was also very uncertain about the risk of serious or any adverse events when FMT was used to maintain remission in CD. None of the studies reported data on use of FMT for maintenance of endoscopic remission or improvement in quality of life in people with CD. AUTHORS' CONCLUSIONS: FMT may increase the proportion of people with active UC who achieve clinical and endoscopic remission. The evidence was very uncertain about whether use of FMT in people with active UC impacted the risk of serious adverse events or improvement in quality of life. The evidence was also very uncertain about the use of FMT for maintenance of remission in people with UC, as well as induction and maintenance of remission in people with CD, and no conclusive statements could be made in this regard. Further studies are needed to address the beneficial effects and safety profile of FMT in adults and children with active UC and CD, as well as its potential to promote longer-term maintenance of remission in UC and CD.

The Effect of Consumption of Animal Milk Compared to Infant Formula for Non-Breastfed/Mixed-Fed Infants 6-11 Months of Age: A Systematic Review and Meta-Analysis.

Many infants do not receive breastmilk for the recommended 2-year duration. Instead, alternative milk beverages are often used, including infant formula and raw animal milk products. The purpose of this systematic review was to summarize the effect of animal milk consumption, compared to infant formula, on health outcomes in non-breastfed or mixed-fed infants aged 6-11 months. We searched multiple databases and followed Cochrane guidelines for conducting the review. The primary outcomes were anemia, gastrointestinal blood loss, weight-for-age, length-for-age, and weight-for-length. Nine studies were included: four randomized controlled trials (RCT) and five cohort studies. All studies, except one, were conducted in high income countries. There was a low certainty of evidence that cow's milk increased the risk of anemia compared to formula milk (Cohort studies RR: 2.26, 95% CI: 1.15, 4.43, RCTs: RR: 4.03, 95% CI: 1.68, 9.65) and gastrointestinal blood loss (Cohort study RR: 1.52, 95% CI: 0.73, 3.16, RCTs: RR: 3.14, 95% CI: 0.98, 10.04). Additionally, there was low certainty evidence that animal milk consumption may not have a differential effect on weight and length-for-age compared to formula milk. Overall, the evidence was of low certainty and no solid conclusions can be drawn from this data. Further studies are needed from low- and middle-income countries to assess optimal milk type in non-breastfed infants aged 6-11 months.

Probiotic Supplementation for Promotion of Growth in Children: A Systematic Review and Meta-Analysis.

Probiotics are commonly prescribed to promote a healthy gut microbiome in children. Our objective was to investigate the effects of probiotic supplementation on growth outcomes in children 0-59 months of age. We conducted a systematic review and meta-analysis which included randomized controlled trials (RCTs) that administered probiotics to children aged 0-59 months, with growth outcomes as a result. We completed a random-effects meta-analysis and calculated a pooled standardized mean difference (SMD) or relative risk (RR) and reported with a 95% confidence interval (CI). We included 79 RCTs, 54 from high-income countries (HIC), and 25 from low- and middle-income countries (LMIC). LMIC data showed that probiotics may have a small effect on weight (SMD: 0.26, 95% CI: 0.11-0.42, grade-certainty = low) and height (SMD 0.16, 95% CI: 0.06-0.25, grade-certainty = moderate). HIC data did not show any clinically meaningful effect on weight (SMD: 0.01, 95% CI: -0.04-0.05, grade-certainty = moderate), or height (SMD: -0.01, 95% CI: -0.06-0.04, grade-certainty = moderate). There was no evidence that probiotics affected the risk of adverse events. We conclude that in otherwise healthy children aged 0-59 months, probiotics may have a small but heterogenous effect on weight and height in LMIC but not in children from HIC.

Pathogen-induced maternal effects result in enhanced immune responsiveness across generations.

Parental investment theory postulates that adults can accurately perceive cues from their surroundings, anticipate the needs of future offspring based on those cues, and selectively allocate nongenetic resources to their progeny. Such context-dependent parental contributions can result in phenotypically variable offspring. Consistent with these predictions, we show that bacterially exposed Manduca sexta mothers oviposited significantly more variable embryos (as measured by mass, volume, hatching time, and hatching success) relative to naïve and control mothers. By using an in vivo "clearance of infection" assay, we also show that challenged larvae born to heat-killed- or live-Serratia-injected mothers, supported lower microbial loads and cleared the infection faster than progeny of control mothers. Our data support the notion that mothers can anticipate the future pathogenic risks and immunological needs of their unborn offspring, providing progeny with enhanced immune protection likely through transgenerational immune priming. Although the inclusion of live Serratia into oocytes does not appear to be the mechanism by which mothers confer protection to their young, other mechanisms, including epigenetic modifications in the progeny due to maternal pathogenic stress, may be at play. The adaptive nature of maternal effects in the face of pathogenic stress provides insights into parental investment, resource allocation, and life-history theories and highlights the significant role that pathogen-induced maternal effects play as generators and modulators of evolutionary change.