Prophylactic Mesh Reinforcement for Prevention of Midline Incisional Hernias: A Publication Bias Adjusted Meta-analysis.

OBJECTIVE: To systematically review the published literature on the use of prophylactic mesh reinforcement of midline laparotomy closures for prevention of VIH. SUMMARY OF BACKGROUND DATA: VIH are common complications of abdominal surgery. Prophylactic mesh has been proposed as an adjunct to prevent their occurrence. METHODS: PubMed, Embase, Scopus, and Cochrane were reviewed for RCTs that compared prophylactic mesh reinforcement versus conventional suture closure of midline abdominal surgery. Primary outcome was the incidence of VIH at postoperative follow-up ≥24 months. Secondary outcomes included surgical site infection and surgical site occurrence (SSO). Pooled risk ratios were obtained through random effect meta-analyses and adjusted for publication bias. Network meta-analyses were performed to compare mesh types and locations. RESULTS: Of 1969 screened articles, 12 RCTs were included. On meta-analysis there was a lower incidence of VIH with prophylactic mesh [11.1% vs 21.3%, Relative risk (RR) = 0.32; 95% confidence interval (CI) = 0.19-0.55, P < 0.001), however, publication bias was highly likely. When adjusted for this bias, prophylactic mesh had a more conservative effect (RR = 0.52; 95% CI = 0.39-0.70). There was no difference in risk of surgical site infection (9.1% vs 8.9%, RR = 1.08, 95% CI = 0.82-1.43; P = 0.118), however, prophylactic mesh increased the risk of SSO (14.2% vs 8.9%, RR = 1.57, 95% CI = 1.19-2.05; P < 0.001). CONCLUSION: Current RCTs suggest that in mid-term follow-up prophylactic mesh prevents VIH with increased risk for SSO. There is limited long-term data and substantial publication bias.

Two-year Outcomes of Prehabilitation Among Obese Patients With Ventral Hernias: A Randomized Controlled Trial (NCT02365194).

OBJECTIVE: To determine if preoperative nutritional counseling and exercise (prehabilitation) improve outcomes in obese patients seeking ventral hernia repair (VHR)? SUMMARY BACKGROUND DATA: Obesity and poor fitness are associated with complications following VHR. It is unknown if preoperative prehabilitation improves outcomes of obese patients seeking VHR. METHODS: This is the 2-year follow-up of a blinded randomized controlled trial from 2015 to 2017 at a safety-net academic institution. Obese patients (BMI 30-40) seeking VHR were randomized to prehabilitation versus standard counseling. Elective VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was percentage of hernia-free and complication-free patients at 2 years. Complications included recurrence, reoperation, and mesh complications. Primary outcome was compared using chi-square. We hypothesize that prehabilitation in obese patients with VHR results in more hernia- and complication-free patients at 2-years. RESULTS: Of the 118 randomized patients, 108 (91.5%) completed a median (range) follow-up of 27.3 (6.2-37.4) months. Baseline BMI (mean±SD) was similar between groups (36.8 ±â€Š2.6 vs 37.0 ±â€Š2.6). More patients in the prehabilitation group underwent emergency surgery (5 vs 1) or dropped out of the program (3 vs 1) compared to standard counseling (13.6% vs 3.4%, P = 0.094). Among patients who underwent surgery, there was no difference in major complications (10.2% vs 9.1%, P = 0.438). At 2-years, there was no difference in percentage of hernia-free and complication-free patients (72.9% vs 66.1%, P = 0.424, 1.14, 0.88-1.47). CONCLUSION: There is no difference in 2-year outcomes of obese patients seeking VHR who undergo prehabilitation versus standard care. Prehabilitation may not be warranted in obese patients undergoing elective VHR.Clinical Trial Registration: This trial was registered with clinicaltrials.gov (NCT02365194).

Validation of the Adapted Clavien-Dindo in Trauma (ACDiT) Classifications in Medical and Surgical Management of Acute Diverticulitis.

OBJECTIVES: To validate the adapted Clavien-Dindo in trauma (ACDiT) tool as a novel outcome measure for patients with acute diverticulitis managed both operatively and nonoperatively. BACKGROUND: Complications following diverticulitis are difficult to classify because no traditional tools address patients managed both operatively and nonoperatively. The ACDiT grading system-graded from 0 to 5b-is applied in this manner but has not yet been validated for this patient group. METHODS: We performed a 5-year observational study of patients with acute diverticulitis at a safety-net hospital. Baseline demographics and hospitalization data were collected. ACDiT scores were assigned, and validation was undertaken by comparing scores with hospital-free days, and verifying that higher scores were associated with known risk factors for poor outcomes. Inverse probability weighted propensity scores were assigned for surgical management, and inverse probability weighted regression analysis was used to determine factors associated with ACDiT ≥ grade 2. RESULTS: Of 260 patients, 188 (72%) were managed nonoperatively. Eighty (31%) developed a complication; 73 (91%) were grades 1 to 3b. Higher grades correlated inversely with hospital-free days (rs = -0.67, P < 0.0001) for all patients and for nonoperative (rs = -0.63, P < 0.0001) and operative (rs = -0.62, P < 0.0001) patients. Hinchey 2 to 3 and initial operative management had higher odds of having a complication of ACDiT ≥ grade 2. CONCLUSION: The ACDiT tool was successfully applied to acute diverticulitis patients managed operatively and nonoperatively, is associated with known risk factors for adverse outcomes. ACDiT may be considered a meaningful outcome measure for comparing strategies for acute diverticulitis.

The Impact of COVID-19 Pandemic Upon Non-elective Admissions and Surgery at a Safety-Net Hospital: A Retrospective Cohort Study.

INTRODUCTION: In response to the COVID-19 pandemic, hospitals reported decreased admissions for acute surgical diagnoses, but scant data was available to quantify the decrease and its consequences. The objective of this study was to examine the incidence of acute care surgery encounters before and during the COVID-19 pandemic. MATERIALS AND METHODS: A retrospective cohort study was performed at a single, urban, United States safety-net hospital. Emergency room encounters, admissions, non-elective surgical procedures, patient acuity, and surgical complications were compared before and after the start of the COVID-19 pandemic. The primary outcome of the study was the incidence rate (IR) and incidence rate ratios (IRR) for surgical admissions, laparoscopic appendectomy, and urgent laparoscopic cholecystectomy. RESULTS: During the COVID-19 (exposure) time period, the number of nonelective procedures was 143 (IR 4.76) which was significantly lower than the control periods (n = 431, IR 7.2), P < 0.001. During the COVID-19 exposure period, there were significantly fewer urgent cholecystectomies performed (1.37 per day versus 2.80-2.93 per day, P < 0.001). There was a trend toward fewer appendectomies performed, but not significant. There was little difference in patient acuity between the exposure and control periods. A higher proportion of patients that underwent urgent cholecystectomy during the COVID time period had been seen in the ED in the prior 30 d (22% versus 5.6%). CONCLUSIONS: Surgical volume significantly decreased during the COVID-19 pandemic. Management of acute cholecystitis may require re-evaluation as nonsurgical management appears to increase repeat presentations.

Robotic Versus Laparoscopic Ventral Hernia Repair: One-year Results From a Prospective, Multicenter, Blinded Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to compare clinical and patient-reported outcomes of robotic versus laparoscopic ventral hernia repair (LVHR) at 1-year postoperative. SUMMARY OF BACKGROUND DATA: Despite a relative lack of research at low risk for bias assessing robotic ventral hernia repair (RVHR), the growth of RVHR has been rapid. We previously reported short-term results of the first randomized control trial comparing RVHR versus LVHR; there was no clear difference in clinical outcomes but increased operative time and cost with robotic repair. METHODS: Patients from a multicenter, blinded randomized control trial comparing RVHR versus LVHR were followed at 1 year. Outcomes included wound complication (surgical site infection, surgical site occurrence, wound dehiscence), hernia occurrence including recurrence and port site hernia, readmission, reoperation, and patient-reported outcomes (functional status, pain, and satisfaction with repair and cosmesis). RESULTS: A total of 124 patients were randomized and 113 patients (91%; 60 robot, 53 laparoscopic) completed 1-year follow-up. Baseline demographics were similar in both groups. No differences were seen in wound complication (15% vs 15%; P = 0.899), hernia recurrence (7% vs 9%; P = 0.576), or readmission (2% vs 6%; P = 0.251). No patients underwent reoperation in the robotic arm, whereas 5 (9%) did in the laparoscopic arm (P = 0.020). No differences were seen in patient-reported outcomes. Both arms reported clinically significant improvements in functional status, low pain scores, and high satisfaction scores at 1-year post repair. CONCLUSION: This study confirms that robotic ventral hernia repair is safe when compared to laparoscopy. Further studies are needed to confirm these findings.

Is robotic surgery feasible at a safety net hospital?

BACKGROUND: Robotic surgery offers potential advantages of improved ability to complete procedures using a minimally invasive approach, recovery, and clinical outcomes. It has been previously established that safety net hospitals are outliers for surgical complications. As such, the adoption of new technology may not achieve the same outcomes as other institutions. We hypothesized that, compared to laparoscopic and open surgeries, robotic surgeries have fewer post-operative Clavien-Dindo complications at our safety net hospital. METHODS: All robotic surgeries performed from 2017 to 2019 at a single, safety net hospital were reviewed. Cases were matched 1:3 to laparoscopic controls. Surgeries commonly performed open were additionally matched 1:3 to open counterparts. The primary outcome was Clavien-Dindo complications at 90 days post-operatively. Secondary outcomes included inadvertent enterotomy, conversion to open, operative duration, wound class, surgical site infection (SSI), surgical site occurrence (SSO), length of stay (LOS), reoperation, readmission, and recurrence. RESULTS: A total of 160 robotic surgeries were included and matched to 480 laparoscopic surgeries and 108 open surgeries. Open surgeries were associated with greater risk of Clavien-Dindo complication (OR = 2.7, p = 0.040, 95% confidence interval 1.0-6.9) than either robotic or laparoscopic surgeries. Robotic cases had increased operative duration when compared to laparoscopic (p < 0.001) but not open cases (p = 0.093). No difference was seen in enterotomy, conversion to open, SSI, SSO, LOS, reoperation, readmission, or recurrence between robotic and laparoscopic, and robotic and open cases. CONCLUSION: Robotic surgery is safe and feasible at a safety net hospital. Robotic and laparoscopic surgeries were associated with fewer Clavien-Dindo complications than open surgery, but no differences were seen between robotic and laparoscopic cases. Robotic surgery, compared to both laparoscopic and open surgery, had longer operative durations. Further studies are needed to assess the value of robotic as opposed to laparoscopic surgery in a safety net setting.

Timely Care is Patient-Centered Care for Patients with Acute Cholecystitis at a Safety-Net Hospital.

BACKGROUND: Multiple strategies exist to improve the timeliness and efficiency of surgical care at safety-net hospitals (SNH), such as acute care surgery models and nighttime surgery. However, the patient-centeredness of such approaches is unknown. METHODS: Adults ( ≥18 years) with acute cholecystitis were interviewed upon admission to a SNH. Interviews were semi-structured and designed to obtain both exploratory qualitative data and ratings of patient-centered outcomes, ranked by importance to the patient. Outcomes included for rating were general health, symptom status, quality of life, and return to prior functional status. Latent content analysis applying inductive coding methods were used to code and condense raw qualitative data from interview transcripts. RESULTS: Thematic saturation was reached with a sample size of 15 patients. Most participants were female (87%), Hispanic (87%), and had prior diagnosis of benign biliary disease (60%). Patients identified symptom resolution as the highest-ranked outcome in their treatment. Themes expressed by patients during the exploratory segments of the interview included: desire for pain alleviation, frustration with delays to both symptom resolution and surgical intervention, lack of perceived control over their health care, and reticence in discussing preferences with physicians. All patients preferred to have surgical treatment as soon as possible, even if that meant having nighttime surgery. CONCLUSIONS: Effective and timely resolution of symptoms is of utmost importance to patients with acute cholecystitis at a SNH. Efforts to improve timeliness of surgical care are also perceived as patient-centered.

Distinct Murine Pancreatic Transcriptomic Signatures during Chronic Pancreatitis Recovery.

We have previously demonstrated that the pancreas can recover from chronic pancreatitis (CP) lesions in the cerulein-induced mouse model. To explore how pancreatic recovery is achieved at the molecular level, we used RNA-sequencing (seq) and profiled transcriptomes during CP transition to recovery. CP was induced by intraperitoneally injecting cerulein in C57BL/6 mice. Time-matched controls (CON) were given normal saline. Pancreata were harvested from mice 4 days after the final injections (designated as CP and CON) or 4 weeks after the final injections (designated as CP recovery (CPR) and control recovery (CONR)). Pancreatic RNAs were extracted for RNA-seq and quantitative (q) PCR validation. Using RNA-seq, we identified a total of 3,600 differentially expressed genes (DEGs) in CP versus CON and 166 DEGs in CPR versus CONR. There are 132 DEGs overlapped between CP and CPR and 34 DEGs unique to CPR. A number of selected pancreatic fibrosis-relevant DEGs were validated by qPCR. The top 20 gene sets enriched from DEGs shared between CP and CPR are relevant to extracellular matrix and cancer biology, whereas the top 10 gene sets enriched from DEGs specific to CPR are pertinent to DNA methylation and specific signaling pathways. In conclusion, we identified a distinct set of DEGs in association with extracellular matrix and cancer cell activities to contrast CP and CPR. Once during ongoing CP recovery, DEGs relevant to DNA methylation and specific signaling pathways were induced to express. The DEGs shared between CP and CPR and the DEGs specific to CPR may serve as the unique transcriptomic signatures and biomarkers for determining CP recovery and monitoring potential therapeutic responses at the molecular level to reflect pancreatic histological resolution.

Primary Fascial Closure During Laparoscopic Ventral Hernia Repair Improves Patient Quality of Life: A Multicenter, Blinded Randomized Controlled Trial.

BACKGROUND: Observational studies have reported conflicting results with primary fascial closure (PFC) versus bridged repair during laparoscopic ventral hernia repair (LVHR). OBJECTIVE: The aim of the study was to determine whether when evaluated in a randomized controlled trial (RCT), PFC compared to bridged repair would improve patient quality of life (QoL). METHODS: In this blinded, multicenter RCT, patients scheduled for elective LVHR (hernia defects 3 to 10 cm on computed tomography scan) were randomized to PFC versus bridged repair. Primary outcome was change in QoL after LVHR using a validated, hernia-specific survey (1 = poor QoL and 100 = perfect QoL) that measures pain, function, cosmesis, and satisfaction. Secondary outcomes were postoperative surgical site occurrences (including hematoma, seroma, surgical site infection, and wound dehiscence), abdominal eventration, and hernia recurrence. The trial was powered to detect a difference in change in QoL of 7 points between the study groups. Outcomes were compared with Mann-Whitney U test or chi-square. RESULTS: A total of 129 patients underwent LVHR and 107 (83%) completed follow-up at 2 years. Patients from both groups were similar at baseline. On median follow-up of 24 months (range: 9-42), patients treated with LVHR-PFC had on average a 12-point higher improvement in QoL compared to bridged repair (improvement in QoL, 41.3 ± 31.5 vs 29.7 ±â€Š28.7, P value = 0.047). There were no differences in surgical site occurrence, eventration, or hernia recurrence between groups. CONCLUSIONS: Among patients undergoing elective LVHR, the fascial defect should be closed. This is the first RCT demonstrating that PFC with LVHR significantly improves patient QoL. TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov (NCT02363790).

Prevalence and Impact on Quality of Life of Occult Hernias among Patients Undergoing Computed Tomography.

BACKGROUND: With the widespread use of advanced imaging there is a need to quantify the prevalence and impact of hernias. We aimed to determine the prevalence of abdominal wall hernias among patients undergoing computed tomography (CT) scans and their impact on abdominal wall quality of life (AW-QOL). METHODS: Patients undergoing elective CT abdomen/pelvis scans were enrolled. Standardized physical examinations were performed by surgeons blinded to the CT scan results. AW-QOL was measured through the modified Activities Assessment Scale. On this scale, 1 is poor AW-QOL, 100 is perfect, and a change of 7 is the minimum clinically important difference. Three surgeons reviewed the CT scans for the presence of ventral or groin hernias. The number of patients and the median AW-QOL scores were determined for three groups: no hernia, hernias only seen on imaging (occult hernias), and clinically apparent hernias. RESULTS: A total of 246 patients were enrolled. Physical examination detected 62 (25.2%) patients with a hernia while CT scan revealed 107 (43.5%) with occult hernias. The median (interquartile range) AW-QOL of patients per group was no hernia = 84 (46), occult hernia = 77 (57), and clinically apparent hernia = 62 (55). CONCLUSIONS: One-fourth of individuals undergoing CT abdomen/pelvis scans have a clinical hernia, whereas nearly half have an occult hernia. Compared with individuals with no hernias, patients with clinically apparent or occult hernias have a lower AW-QOL (by 22 and seven points, respectively). Further studies are needed to determine natural history of AW-QOL and best treatment strategies for patients with occult hernias.

Gender Disparity Among Surgical Peer-Reviewed Literature.

BACKGROUND: Women remain under-represented in academic surgery despite increasing percentages of female surgeons and surgery residents. Publications and leadership positions are used for hiring and promoting academic surgeons. We sought to determine the disparity of female authorship when compared with male authors in surgical peer-reviewed publications. METHODS: PubMed was searched for surgical publications from the United States. Obstetrics and gynecology was selected as a control specialty owing to its history of high female representation. Thirteen other surgical specialties were randomly selected from the Accreditation Council for Graduate Medical Education specialty list. Manuscripts from four time periods, 2000-2005, 2006-2010, 2011-2015, and 2016-2017, were randomly selected, and the gender of the first and last authors was determined. The Accreditation Council for Graduate Medical Education and Association of American Medical Colleges databases were used to determine women representation in surgery. Trends were assessed using the Cochran-Armitage test. RESULTS: In total, 560 manuscripts in 14 specialties were reviewed. In the control specialty, 51% of first authors were female compared with 18% of those in study specialties, and 39% of last authors were female compared with 11% of those in study specialties. No difference was found when comparing the gender of first (P-value = 0.393) and/or last authors (P-value = 0.281) with the proportion of female residents and attendings. CONCLUSIONS: Women surgeons publish research at a rate proportional to the number of females involved in that specialty. Disparities in leadership roles are unlikely explained by differences in publications. Instead, disparities are likely due to other reasons such as failure to attract women to academic surgery and failure to promote and mentor women surgeons into leadership positions.

Lack of Regulations and Conflict of Interest Transparency of New Hernia Surgery Technologies.

BACKGROUND: Medical devices introduced to market through the 510K process often have limited research of low quality and substantial conflict of interest (COI). By the time high-quality safety and effectiveness research is performed, thousands of patients may have already been treated by the device. Our aim was to systematically review the trends of outcomes, research quality, and financial relationships of published studies related to de-adopted meshes for ventral hernia repair. MATERIALS AND METHODS: Literature was systematically reviewed using PubMed to obtain all published studies related to three de-adopted meshes: C-QUR, Physiomesh, and meshes with polytetrafluoroethylene. Primary outcome was change in cumulative percentage of subjects with positive published outcomes. Secondary outcome was percentage of published manuscript with COI. RESULTS: A total of 723 articles were screened, of which, 129 were analyzed and included a total of 8081 subjects. Percentage of subjects with positive outcomes decreased over time for all groups: (1) C-QUR from 100% in 2009 to 22% in 2018, (2) Physiomesh from 100% in 2011 to 20% in 2018, and (3) polytetrafluoroethylene from 100% in 1979 to 49% in 2018. Authors of only 20% of articles self-reported no COI, most representing later publications and were more likely to show neutral or negative results. CONCLUSIONS: Among three de-adopted meshes, early publications demonstrated overly optimistic results followed by disappointing outcomes. Skepticism over newly introduced, poorly proven therapies is essential to prevent adoption of misleading practices and products. Devices currently approved under the 510K processes should undergo blinded, randomized controlled trials before introduction to the market.

Is the American College of Surgeons Online Communities a safe and useful venue to ask for surgical advice?

BACKGROUND: Many surgeons rely on the American College of Surgeons (ACS) Community Forums for advice on managing complex patients. Our objective was to assess the safety and usefulness of advice provided on the most popular surgical forum. METHODS: Overall, 120 consecutive, deidentified clinical threads were extracted from the General Surgery community in reverse chronological order. Three groups of three surgeons (mixed academic and community perspectives) evaluated the 120 threads for unsafe or dangerous posts. Positive and negative controls for safe and unsafe answers were included in 20 threads, and reviewers were blinded to their presence. Reviewers were free to access all online and professional resources. RESULTS: There were 855 unique responses (median 7, 2-15 responses per thread) to the 120 clinical threads/scenarios. The review teams correctly identified all positive and negative controls for safety. While 58(43.3%) of threads contained unsafe advice, the majority (33, 56.9%) were corrected. Reviewers felt that a there was a standard of care response for 62/120 of the threads of which 50 (80.6%) were provided by the responses. Of the 855 responses, 107 (12.5%) were considered unsafe/dangerous. CONCLUSION: The ACS Community Forums are generally a safe and useful resource for surgeons seeking advice for challenging cases. While unsafe or dangerous advice is not uncommon, other surgeons typically correct it. When utilizing the forums, advice should be taken as a congregate, and any single recommendation should be approached with healthy skepticism. However, social media such as the ACS Forums is self-regulating and can be an appropriate method for surgeons to communicate challenging problems.

Are online surgical discussion boards a safe and useful venue for surgeons to ask for advice? A review of the International Hernia Collaboration Facebook Group.

BACKGROUND: Social media is a growing medium for disseminating information among surgeons. The International Hernia Collaboration Facebook Group (IHC) is a widely utilized social media platform to share ideas and advice on managing patients with hernia-related diseases. Our objective was to assess the safety and utility of advice provided. METHODS: Overall, 60 consecutive de-identified clinical threads were extracted from the IHC in reverse chronological order. A group of three hernia specialists evaluated all threads for unsafe posts, unhelpful comments, and if an established evidence-based management strategy was provided. Positive and negative controls for safe and unsafe answers were included in seven threads and reviewers were blinded to their presence. Reviewers were free to access all online and professional resources (except the IHC). RESULTS: There were 598 unique responses (median 10, 1-26 responses per thread) to the 60 clinical threads/scenarios. The review team correctly identified all seven positive and negative controls. Most responses were safe (96.6%) but some were unhelpful (28.4%). For sixteen threads, the reviewers believed there was an established evidence-based answer; however, only six were provided. In addition, 14 responses were considered unsafe, but only four were corrected. CONCLUSIONS: The vast majority of responses were considered helpful; however, evidence-based management is typically not provided and unsafe recommendations often go uncontested. While the IHC allows wide dissemination of hernia-related surgical advice/discussions, surgeons should be cautious when using the IHC for clinical advice. Mechanisms to provide evidence-based management strategies and to identify unsafe advice are needed to improve quality within online forums and to prevent patient harm.

Port Site Hernias Following Laparoscopic Ventral Hernia Repair.

BACKGROUND: Port site hernias (PSH) are underreported following laparoscopic ventral hernia repair (LVHR). Most occur at the site of laterally placed 10-12-mm ports used to introduce large pieces of mesh. One alternative is to place the large port through the ventral hernia defect; however, there is potential for increased risk of surgical site infection (SSI). This study evaluates the outcomes when introducing mesh through a 10-12-mm port placed through the hernia defect. METHODS: This was a retrospective case series of patients who underwent LVHR in three prospective trials from 2014-2017 at one institution. All patients had mesh introduced through a 10-12-mm port placed through the ventral hernia defect. The primary outcome was SSI. Secondary outcomes were hernia occurrences including recurrences and PSH. RESULTS: A total of 315 eligible patients underwent LVHR with a median (range) follow-up of 21 (11-41) months. Many patients were obese (66.9%), recently quit tobacco use (8.8%), or had diabetes (18.9%). Most patients had an incisional hernia (61.2%), and 19.2% were recurrent. Hernias were on average 4.8 ± 3.8 cm in width. Two patients (0.6%) had an SSI. Fourteen patients had a hernia occurrence-13 (4.4%) had a recurrent hernia, and one patient (0.3%) had a PSH. CONCLUSION: During LVHR, introduction of mesh through a 10-12-mm port placed through the hernia defect is associated with a low risk of SSI and low risk of hernia occurrence. While further studies are needed to confirm these results, mesh can be safely introduced through a port through the defect.

Expectant Management of Patients with Ventral Hernias: 3 Years of Follow-up.

BACKGROUND: The safety and effectiveness of expectant management (e.g., watchful waiting or initially managing non-operatively) for patients with a ventral hernia is unknown. We report our 3-year results of a prospective cohort of patients with ventral hernias who underwent expectant management. METHODS: A hernia clinic at an academic safety-net hospital was used to recruit patients. Any patient undergoing expectant management with symptoms and high-risk comorbidities, as determined by a surgeon based on institutional criteria, would be included in the study. Patients unlikely to complete follow-up assessments were excluded from the study. Patient-reported outcomes were collected by phone and mailed surveys. A modified activities assessment scale normalized to a 1-100 scale was used to measure results. The rate of operative repair was the primary outcome, while secondary outcomes include rate of emergency room (ER) visits and both emergent and elective hernia repairs. RESULTS: Among 128 patients initially enrolled, 84 (65.6%) completed the follow-up at a median (interquartile range) of 34.1 (31, 36.2) months. Overall, 28 (33.3%) patients visited the ER at least once because of their hernia and 31 (36.9%) patients underwent operative management. Seven patients (8.3%) required emergent operative repair. There was no significant change in quality of life for those managed non-operatively; however, substantial improvements in quality of life were observed for patients who underwent operative management. CONCLUSIONS: Expectant management is an effective strategy for patients with ventral hernias and significant comorbid medical conditions. Since the short-term risk of needing emergency hernia repair is moderate, there could be a safe period of time for preoperative optimization and risk-reduction for patients deemed high risk.

Gallstone Pancreatitis: Admission Versus Normal Cholecystectomy-a Randomized Trial (Gallstone PANC Trial).

INTRODUCTION: Early cholecystectomy shortly after admission for mild gallstone pancreatitis has been proposed based on observational data. We hypothesized that cholecystectomy within 24 hours of admission versus after clinical resolution of gallstone pancreatitis that is predicted to be mild results in decreased length-of-stay (LOS) without an increase in complications. METHODS: Adults with predicted mild gallstone pancreatitis were randomized to cholecystectomy with cholangiogram within 24 hours of presentation (early group) versus after clinical resolution (control) based on abdominal exam and normalized laboratory values. Primary outcome was 30-day LOS including readmissions. Secondary outcomes were time to surgery, endoscopic retrograde cholangiopancreatography (ERCP) rates, and postoperative complications. Frequentist and Bayesian intention-to-treat analyses were performed. RESULTS: Baseline characteristics were similar in the early (n = 49) and control (n = 48) groups. Early group had fewer ERCPs (15% vs 29%, P = 0.038), faster time to surgery (16 h vs 43 h, P < 0.005), and shorter 30-day LOS (50 h vs 77 h, RR 0.68 95% CI 0.65 - 0.71, P < 0.005). Complication rates were 6% in early group versus 2% in controls (P = 0.613), which included recurrence/progression of pancreatitis (2 early, 1 control) and a cystic duct stump leak (early). On Bayesian analysis, early cholecystectomy has a 99% probability of reducing 30-day LOS, 93% probability of decreasing ERCP use, and 72% probability of increasing complications. CONCLUSION: In patients with predicted mild gallstone pancreatitis, cholecystectomy within 24 hours of admission reduced rate of ERCPs, time to surgery, and 30-day length-of-stay. Minor complications may be increased with early cholecystectomy. Identification of patients with predicted mild gallstone pancreatitis in whom early cholecystectomy is safe warrants further investigation.

The Effect of Financial Conflict of Interest, Disclosure Status, and Relevance on Medical Research from the United States.

BACKGROUND: Financial interactions between industry and healthcare providers are reportable. Substantial discrepancies have been detected between industry and self-report of these conflicts of interest (COIs). OBJECTIVE: Our aim was to determine if authors who fail to disclose reportable COI are more likely to publish findings that are favorable to industry than authors with no COI. DESIGN: In this blinded, observational study of medical and surgical primary research articles in PubMed, 590 articles were reviewed. MAIN MEASURES: Reportable financial relationships between authors and industry were evaluated. COIs were considered to have relevance if they were associated with the product(s) mentioned by an article. Primary outcome was favorability, defined as an impression favorable to the product(s) discussed by an article and determined by 3 independent, blinded clinicians for each article. Primary analysis compared Incomplete Self-Disclosure to No COI. Two-level multivariable mixed-effects ordered logistic regression was used to assess factors associated with favorability. KEY RESULTS: A 69% discordance rate existed between industry and self-report in COI disclosure. When authors failed to disclose COI, their conclusions were more likely to favor industry partners than authors without COI (favorable ratings 73% versus 62%, RR 1.18, p = < 0.001). On univariate (any COI 74% versus no COI 62%, RR 1.11, p = < 0.001) and multivariable analyses, any COI was associated with favorability. CONCLUSIONS: All financial COIs (disclosed or undisclosed, relevant or not relevant, research or non-research) influence whether studies report findings favorable to industry sponsors.

Modifying Risks in Ventral Hernia Patients With Prehabilitation: A Randomized Controlled Trial.

OBJECTIVE: The aim of this study was to determine whether preoperative nutritional counseling and exercise (prehabilitation) in obese patients with ventral hernia repair (VHR) results in more hernia-free and complication-free patients. BACKGROUND: Obesity and poor fitness are associated with complications following VHR. These issues are prevalent in low socioeconomic status patients. METHODS: This was a blinded, randomized controlled trial at a safety-net academic institution. Obese patients (BMI 30 to 40) seeking VHR were randomized to prehabilitation versus standard counseling. VHR was performed once preoperative requirements were met: 7% total body weight loss or 6 months of counseling and no weight gain. Primary outcome was the proportion of hernia-free and complication-free patients. Secondary outcomes were wound complications at 1 month postoperative and weight loss measures. Univariate analysis was performed. RESULTS: Among 118 randomized patients, prehabilitation was associated with a higher percentage of patients who lost weight and achieved weight loss goals; however, prehabilitation was also associated with a higher dropout rate and need for emergent repair. VHR was performed in 44 prehabilitation and 34 standard counseling patients. There was a trend toward less wound complication in prehabilitation patients (6.8% vs 17.6%, P = 0.167). The prehabilitation group was more likely to be hernia-free and complication-free (69.5% vs 47.5%, P = 0.015). CONCLUSIONS: It is feasible to implement a prehabilitation program for obese patients at a safety-net hospital. Prehabilitation patients have a higher likelihood of being hernia-free and complication-free postoperatively. Although further trials and long-term outcomes are needed, prehabilitation may benefit obese surgical patients, but there may be increased risks of dropout and emergent repair. CLINICAL TRIAL REGISTRATION: This trial was registered with clinicaltrials.gov (NCT02365194).

The Changes of MicroRNA Expression in the Corpus Cavernosum of a Rat Model With Cavernous Nerve Injury.

BACKGROUND: MicroRNAs (miRs) were found to be dysregulated in erectile dysfunction (ED) related to aging, type 2 diabetes mellitus, and vasculogenic abnormalities. However, miR expression in ED after radical prostatectomy (RP) is not known. AIM: To detect abnormal miR expression in post-RP ED and analyze target genes and pathways. METHODS: 16 Sprague Dawley rats were divided into bilateral cavernous nerve crush (BCNC) and control groups. 4 weeks after surgery, erectile function and histological change in the corpus cavernosum were evaluated. Total RNA from 3 rats from each group was isolated and processed to analyze the miR expression profiling by RNA sequencing. The top 10 up-regulated miR profiles were chosen directly and further validated in another 5 rats per each group by quantitative real-time polymerase chain (PCR) reaction. The target genes were predicted by online databases, including: TargetScan, mirwalk, miRanda, miRDB, and DIANA. The enrichment analysis of gene ontology-term analysis and Kyoto Encyclopedia of Genes and Genomes were performed by DAVID database. OUTCOMES: Intra-cavernosal pressure, mean arterial pressure, smooth muscle content, and miR expression were measured. RESULTS: Compared to the control group, the BCNC group had decreased intra-cavernosal/mean arterial pressure ratio and smooth muscle marker (α-smooth muscle actin). The sequence results showed that 124 miR expression dysregulated in the BCNC group, in which 122 miR expression were up-regulated. Of the 122 miRs, 21 miR expressions were increased above 2-fold. Among the top 10 up-regulated miRs, 4 miRs (miR-101a, miR-138, miR-338, and miR-142) levels were finally validated for over-expression by quantitative (PCR) reaction. The gene ontology analysis results showed that these 4 miRs could regulate the processes of cell apoptosis, fibrosis, endothelium, and smooth muscle cells function. The Kyoto Encyclopedia of Genes and Genomes pathway analysis showed the target genes were involved in 7 pathways related to ED. CLINICAL TRANSLATION: Our findings provide novel insights into post-RP ED that may stimulate further studies to develop miR targeted therapy or damage detection for ED. STRENGTHS & LIMITATIONS: To our knowledge, this is the first study to identify the miR profiling and function in the BCNC rat model. The rat model might not represent the human condition and the miR was only detected at 1 period. Besides that, there is a high probability of false positives for RNA sequence results. CONCLUSION: 4 dysregulated miRs were found in the BCNC rat model, which may be related to post-RP ED by regulating apoptosis, fibrosis, endothelial, and smooth muscle cells. Liu C, Cao Y, Ko TC, et al. The Changes of MicroRNA Expression in the Corpus Cavernosum of a Rat Model With Cavernous Nerve Injury. J Sex Med 2018;15:958-965.