TAVAC: comprehensive review of currently available hemostatic products as adjunct to surgical hemostasis.

BACKGROUND: The use of hemostatic agents by general surgeons during abdominal operations is commonplace as an adjunctive measure to minimize risks of postoperative bleeding and its downstream complications. Proper selection of products can be hampered by marginal understanding of their pharmacokinetics and pharmacodynamics. While a variety of hemostatic agents are currently available on the market, the choice of those products is often confusing for surgeons. This paper aims to summarize and compare the available hemostatic products for each clinical indication and to ultimately better guide surgeons in the selection and proper use of hemostatic agents in daily clinical practice. METHODS: We utilized PubMed electronic database and published product information from the respective pharmaceutical companies to collect information on the characteristics of the hemostatic products. RESULTS: All commercially available hemostatic agents in the US are described with a description of their mechanism of action, indications, contraindications, circumstances in which they are best utilized, and expected results. CONCLUSION: Hemostatic products come with many different types and specifications. They are valuable tools to serve as an adjunct to surgical hemostasis. Proper education and knowledge of their characteristics are important for the selection of the right agent and optimal utilization.

Laparoscopic vs robotic inguinal hernia repair: a comparison of learning curves and skill transference in general surgery residents.

BACKGROUND: There is no consensus on whether laparoscopic experience should be a prerequisite for robotic training. Further, there is limited information on skill transference between laparoscopic and robotic techniques. This study focused on the general surgery residents' learning curve and skill transference within the two minimally invasive platforms. METHODS: General surgery residents were observed during the performance of laparoscopic and robotic inguinal hernia repairs. The recorded data included objective measures (operative time, resident participation indicated by percent active time on console or laparoscopy relative to total case time, number of handoffs between the resident and attending), and subjective evaluations (preceptor and trainee assessments of operative performance) while controlling for case complexity, patient comorbidities, and residents' prior operative experience. Wilcoxon two-sample tests and Pearson Correlation coefficients were used for analysis. RESULTS: Twenty laparoscopic and forty-four robotic cases were observed. Mean operative times were 90 min for robotic and 95 min for laparoscopic cases (P = 0.4590). Residents' active participation time was 66% on the robotic platform and 37% for laparoscopic (P = < 0.0001). On average, hand-offs occurred 9.7 times during robotic cases and 6.3 times during laparoscopic cases (P = 0.0131). The mean number of cases per resident was 5.86 robotic and 1.67 laparoscopic (P = 0.0312). For robotic cases, there was a strong correlation between percent active resident participation and their prior robotic experience (r = 0.78) while there was a weaker correlation with prior laparoscopic experience (r = 0.47). On the other hand, prior robotic experience had minimal correlation with the percent active resident participation in laparoscopic cases (r = 0.12) and a weak correlation with prior laparoscopic experience (r = 0.37). CONCLUSION: The robotic platform may be a more effective teaching tool with a higher degree of entrustability indicated by the higher mean resident participation. We observed a greater degree of skill transference from laparoscopy to the robot, indicated by a higher degree of correlation between the resident's prior laparoscopic experience and the percent console time in robotic cases. There was minimal correlation between residents' prior robotic experience and their participation in laparoscopic cases. Our findings suggest that the learning curve for the robot may be shorter as prior robotic experience had a much stronger association with future robotic performance compared to the association observed in laparoscopy.

What influences general surgery residents' prospective entrustment and operative time in robotic inguinal hernia repairs.

INTRODUCTION: Teaching residents robotic-assisted inguinal hernia repair (RIHR) is an increasingly common extension of contemporary surgical training. This study sought to investigate what variables would influence operative time (OT) and resident prospective entrustment in RIHR cases. METHODS: We prospectively collected 68 resident RIHR operative performance evaluations with a validated instrument. Outpatient RIHR cases performed by 11 general surgery residents during 2020-2022 were included. The overall OT of matched cases was extracted from hospital billing; matched procedural step-specific OT was obtained from Intuitive Data Recorder (IDR). Statistical analysis was performed using Pearson correlation and one-way ANOVA. RESULTS: The evaluation instrument reliably assessed residents' RIHR performance (Cronbach's α = 0.93); residents' prospective entrustment strongly correlated with overall guidance provided by attending surgeon (r = 0.86, p < 0.0001) and operative plan and judgment (r = 0.85, p < 0.0001). The overall OT was significantly associated with resident's team management (r = - 0.35, p = 0.011). Procedural step-specific OT was significantly associated with residents' step-specific skill (r = - 0.32, p = 0.014). On average, RIHR cases with the highest level of prospective entrustment (Resident can teach junior) showed the shortest step-specific OT. Entrustment level 3 (Reactive guidance needed) was the turning point of all four RIHR procedural step-specific OT. CONCLUSIONS: Our findings suggest that in RIHR, attending guidance, resident operative plan and judgment, and resident technical skill contribute to resident prospective entrustment; resident team management, technical skill, and attending guidance influence operative time, which in turn impacts attendings' determination of resident prospective entrustment. Future studies with a larger sample size are needed to further validate the findings.

The robot doesn't lie: real-life validation of robotic performance metrics.

BACKGROUND: Degree of resident participation in a case is often used as a surrogate marker for operative autonomy, an essential element of surgical resident training. Previous studies have demonstrated a considerable disagreement between the perceptions of attending surgeons and trainees when it comes to estimating operative participation. The Da Vinci Surgical System dual console interface allows machine generated measurements of trainee's active participation, which has the potential to obviate the need for labor intensive direct observation of surgical procedures. However, the robotic metrics require validation. We present a comparison of operative participation as perceived by the resident, faculty, trained research staff observer (gold standard), and robotic machine generated data. METHODS: A total of 28 consecutive robotic inguinal hernia repair procedures were observed by research staff. Operative time, percent active time for the resident, and number of handoffs between the resident and attending were recorded by trained research staff in the operating room and the Da Vinci Surgical System. Attending and resident evaluations of operative performance and perceptions of percent active time for the resident were collected using standardized forms and compared with the research staff observed values and the robot-generated console data. Wilcoxon two-sample tests and Pearson Correlation coefficients statistical analysis were performed. RESULTS: Robotic inguinal hernia repair cases had a mean operative time of 91.3 (30) minutes and an attending-rated mean difficulty of 3.1 (1.26) out of 5. Residents were recorded to be the active surgeon 71.8% (17.7) of the total case time by research staff. There was a strong correlation (r = 0.77) in number of handoffs between faculty and trainee as recorded by the research staff and robot (4.28 (2.01) vs. 5.8 (3.04) respectively). The robotic machine generated data demonstrated the highest degree of association when compared to the gold standard (research staff observed data), with r = 0.98, p < 0.0001. Lower levels of association were seen with resident reported (r = 0.66) perceptions and faculty-reported (r = 0.55) perceptions of resident active operative time. CONCLUSIONS: Our findings suggest that robot-generated performance metrics are an extremely accurate and reliable measure of intraoperative resident participation indicated by a very strong correlation with the data recorded by research staff's direct observation of the case. Residents demonstrated a more accurate awareness of their degree of participation compared with faculty surgeons. With high accuracy and ease of use, robotic surgical system performance metrics have the potential to be a valuable tool in surgical training and skill assessment.

Robotic eTEP versus IPOM evaluation: the REVEAL multicenter randomized clinical trial.

BACKGROUND: For small to medium-sized ventral hernias, robotic intraperitoneal onlay mesh (rIPOM) and enhanced-view totally extraperitoneal (eTEP) repair have emerged as acceptable approaches that each takes advantage of robotic instrumentation. We hypothesized that avoiding mesh fixation in a robotic eTEP repair offers an advantage in early postoperative pain compared to rIPOM. METHODS: This is a multi-center, randomized clinical trial for patients with midline ventral hernias ≤ 7 cm, who were randomized to rIPOM or robotic eTEP. The primary outcome was pain (0-10) on the first postoperative day. Secondary outcomes included same-day discharge, length of stay, opioid consumption, quality of life, surgeon workload, and cost. RESULTS: Between November 2019 and November 2021, 100 patients were randomized (49 rIPOM, 51 eTEP) among 5 surgeons. Pain on the first postoperative day [median (IQR): 5 (4-6) vs. 5 (3.5-7), p = 0.66] was similar for rIPOM and eTEP, respectively, a difference maintained following adjustments for surgeon, operative time, baseline pain, and patient co-morbidities (difference 0.28, 95% CI - 0.63 to 1.19, p = 0.56). No differences in pain on the day of surgery, 7, and 30 days after surgery were identified. Same-day discharge, length of stay, opioid consumption, and 30-day quality of life were also comparable, though rIPOM required less surgeon workload (p < 0.001), shorter operative time [107 (86-139) vs. 165 (129-212) min, p < 0.001], and resulted in fewer surgical site occurrences (0 vs. 8, p = 0.004). The total direct costs for rIPOM and eTEP were comparable [$8282 (6979-11835) vs. $8680 (7550-10282), p = 0.52] as the cost savings for eTEP attributable to mesh use [$442 (434-485) vs. $69 (62-76), p = < 0.0001] were offset by increased expenses for operative time [$669 (579-861) vs. $1075 (787-1367), p < 0.0001] and use of more robotic equipment [$760 (615-933) vs. $946 (798-1203), p = 0.001]. CONCLUSION: The avoidance of fixation in a robotic eTEP repair did not reveal a benefit in postoperative pain to offset the shorter operative time and surgeon workload offered by rIPOM.

Near-infrared fluorescent cholangiography facilitates identification of biliary anatomy during laparoscopic cholecystectomy.

BACKGROUND: Intraoperative cholangiography (IOC) is the current gold standard for biliary imaging during laparoscopic cholecystectomy (LC). However, utilization of IOC remains low. Near-infrared fluorescence cholangiography (NIRF-C) is a novel, noninvasive method for real-time, intraoperative biliary mapping. Our aims were to assess the safety and efficacy of NIRF-C for identification of biliary anatomy during LC. METHODS: Patients were administered indocyanine green (ICG) prior to surgery. NIRF-C was used to identify extrahepatic biliary structures before and after partial and complete dissection of Calot's triangle. Routine IOC was performed in each case. Identification of biliary structures using NIRF-C and IOC, and time required to complete each procedure were collected. RESULTS: Eighty-two patients underwent elective LC with NIRF-C and IOC. Mean age and body mass index (BMI) were 42.6 ± 13.7 years and 31.5 ± 8.2 kg/m(2), respectively. ICG was administered 73.8 ± 26.4 min prior to incision. NIRF-C was significantly faster than IOC (1.9 ± 1.7 vs. 11.8 ± 5.3 min, p < 0.001). IOC was unobtainable in 20 (24.4 %) patients while NIRF-C did not visualize biliary structures in 4 (4.9 %) patients. After complete dissection, the rates of visualization of the cystic duct, common bile duct, and common hepatic duct using NIRF-C were 95.1, 76.8, and 69.5 %, respectively, compared to 72.0, 75.6, and 74.3 % for IOC. In 20 patients where IOC could not be obtained, NIRF-C successfully identified biliary structures in 80 % of the cases. Higher BMI was not a deterrent to visualization of anatomy with NIRF-C. No adverse events were observed with NIRF-C. CONCLUSIONS: NIRF-C is a safe and effective alternative to IOC for imaging extrahepatic biliary structures during LC. This technique should be evaluated further under a variety of acute and chronic gallbladder inflammatory conditions to determine its usefulness in biliary ductal identification.

Obesity-associated microbiomes instigate visceral adipose tissue inflammation by recruitment of distinct neutrophils.

Neutrophils are increasingly implicated in chronic inflammation and metabolic disorders. Here, we show that visceral adipose tissue (VAT) from individuals with obesity contains more neutrophils than in those without obesity and is associated with a distinct bacterial community. Exploring the mechanism, we gavaged microbiome-depleted mice with stool from patients with and without obesity during high-fat or normal diet administration. Only mice receiving high-fat diet and stool from subjects with obesity show enrichment of VAT neutrophils, suggesting donor microbiome and recipient diet determine VAT neutrophilia. A rise in pro-inflammatory CD4+ Th1 cells and a drop in immunoregulatory T cells in VAT only follows if there is a transient spike in neutrophils. Human VAT neutrophils exhibit a distinct gene expression pattern that is found in different human tissues, including tumors. VAT neutrophils and bacteria may be a novel therapeutic target for treating inflammatory-driven complications of obesity, including insulin resistance and colon cancer.

Analysis of perioperative factors and cost comparison of single-incision and traditional multi-incision laparoscopic cholecystectomy.

BACKGROUND: Recent technological advances in single-incision platforms have allowed many general surgeons to add single-incision laparoscopic cholecystectomy (SILC) to their armamentarium. However, adopting new surgical technologies comes at a cost to the patient and the surgeon. This study compared retrospective case-matched SILC and traditional multi-incision laparoscopic cholecystectomy (MILC) to evaluate the effects of SILC on perioperative outcomes and patient cost. METHODS: The study compared 50 patients who underwent SILC with a case-matched population of individuals who underwent traditional MILC. The SILC technique was performed using one of three commercially available single-incision platforms currently used for single-incision laparoscopic surgery (SILS) cholecystectomies. All the SILS platforms were placed in a 2-cm supraumbilical incision. All statistical analyses were performed using Microsoft Excel 2008 for Macintosh, with statistical significance determined by a p value of 0.05 or less. RESULTS: The average operative time was 42 min for the SILC group and 45 min for the MILC group. The difference was not statistically significant. Similarly, the average estimated blood loss was 14 ml for the SILC group and 11 ml for the MILC group. Again, the difference was not statistically significant. Moreover, the body mass index (BMI) did not differ statistically between the SILC group (28.4 kg/m(2)) and the MILC group (32.2 kg/m(2)). The average patient cost was $18,447 for SILC and $17,701 for MILC, yielding a cost difference of $746. This difference was not statistically significant. CONCLUSIONS: At the authors' institution, SILS cholecystectomy was performed with blood loss, operating room time, and cost equal to that for MILC. Further research is necessary to assess the economic feasibility of SILC and the trade-off of cost with the improved cosmesis, decreased pain, greater patient satisfaction, reduced postoperative analgesic requirement, and faster return to work to determine the overall value and superiority of SILC compared with MILC.

Robotic Enhanced-View Totally Extraperitoneal vs Intraperitoneal Onlay Mesh Evaluation: 1-Year Exploratory Outcomes of the REVEAL Randomized Clinical Trial.

BACKGROUND: Patients with small- to medium-sized ventral hernias randomized to robotic enhanced-view totally extraperitoneal (eTEP) or robotic intraperitoneal onlay mesh (rIPOM) previously demonstrated comparable 30-day patient-reported outcomes. Here we report 1-year exploratory outcomes for this multi-center, patient-blinded randomized clinical trial. STUDY DESIGN: Patients with midline ventral hernias 7 cm wide or less undergoing mesh repair were randomized to robotic eTEP or rIPOM. Planned exploratory outcomes at 1 year include pain intensity (using the Patient-Reported Outcomes Measurement Information System [PROMIS 3a]), Hernia-Related Quality of Life Survey (HerQLes) scores, pragmatic hernia recurrence, and reoperation. RESULTS: One hundred randomized patients (51 eTEP, 49 rIPOM) reached a median 12-month follow-up (interquartile range 11 to 13) with 7% lost. After regression analysis adjusting for baseline scores, there was no difference in postoperative pain intensity at 1-year for eTEP compared with rIPOM (odds ratio [OR] 2.1 [95% CI 0.85 to 5.1]; p = 0.11). HerQLes scores were 15 points lower on average (ie less improved) at 1 year after eTEP repairs compared with rIPOM, a difference maintained after regression analysis (OR 0.31 [95% CI 0.15 to 0.67]; p = 0.003). Pragmatic hernia recurrence was 12.2% (6 of 49) for eTEP and 15.9% (7 of 44) for rIPOM (p = 0.834). In the first year, 2 eTEP and 1 rIPOM patients required reoperations related to their index repair (p = 0.82). CONCLUSIONS: Exploratory analyses showed similar outcomes at 1 year in regard to pain, hernia recurrence, and reoperation. Abdominal wall quality of life at 1 year appears to favor rIPOM, and the possibility that an eTEP dissection is less advantageous in that regard should be the subject of future investigation.

Near-Peer Teaching in Conjunction with Flipped Classroom to Teach First-Year Medical Students Basic Surgical Skills.

Background: There is increasing evidence that students are completing medical school with insufficient surgical education. Near-peer tutoring and flipped classroom formatting may be used to enhance learning while simultaneously relieving faculty burden of teaching. Here, we qualitatively evaluate a 3-month course that integrates the use of near-peer teaching and flipped classroom formatting, with the goal of increasing first-year medical students' self-perceived confidence in performing basic sutures and knot-ties as well as interest in surgery. Methods: Twenty-one first-year medical students participated in a suturing and knot-tying course led by senior medical students. The course consisted of 2-h sessions held every 2 weeks for a total of five sessions. Students were sent publicly available videos prior to each session by which to learn the upcoming techniques and received live feedback from instructors during sessions. Questionnaires were completed pre-course and post-course. Results: Compared to pre-course ratings, post-course ratings of self-perceived confidence to perform various knot-ties and sutures all increased significantly (p < 0.05). All students stated that the course strengthened their desire to pursue a career in surgery. Student feedback of the course was overall positive. Conclusions: Near-peer teaching can be used in conjunction with flipped classroom to increase first-year medical students' self-perceived confidence in surgical suturing and knot-tying as well as interest in surgery. This curriculum may serve as an outline for student-led courses at other institutions.

Interferon gamma mediates the reduction of adipose tissue regulatory T cells in human obesity.

Decreased adipose tissue regulatory T cells contribute to insulin resistance in obese mice, however, little is known about the mechanisms regulating adipose tissue regulatory T cells numbers in humans. Here we obtain adipose tissue from obese and lean volunteers. Regulatory T cell abundance is lower in obese vs. lean visceral and subcutaneous adipose tissue and associates with reduced insulin sensitivity and altered adipocyte metabolic gene expression. Regulatory T cells numbers decline following high-fat diet induction in lean volunteers. We see alteration in major histocompatibility complex II pathway in adipocytes from obese patients and after high fat ingestion, which increases T helper 1 cell numbers and decreases regulatory T cell differentiation. We also observe increased expression of inhibitory co-receptors including programmed cell death protein 1 and OX40 in visceral adipose tissue regulatory T cells from patients with obesity. In human obesity, these global effects of interferon gamma to reduce regulatory T cells and diminish their function appear to instigate adipose inflammation and suppress adipocyte metabolism, leading to insulin resistance.

Laparoscopic ventral hernia repair.

Ventral hernias, whether naturally occurring or the result of previous surgery, comprise one of the most common problems confronting general surgeons. As many as 25% of laparotomy incisions develop a hernia over long-term follow-up, which is a difficult problem with many treatment algorithms. Laparoscopic ventral hernia repair has improved over the last decade and has proven to be an effective treatment option. With fewer wound complications and low recurrence rates, it is a useful tool in the surgeon's armamentarium. Care should be taken regarding patient selection, operative technique, and mesh size to ensure adequate repair of the hernia, thereby preventing recurrence at a later date. The first attempt at a hernia repair has the highest chance of long-term success, so it is important that the surgeon take all the factors into mind before proceeding with operative repair.

Transgastric endoscopic peritoneoscopy does not require decontamination of the stomach in humans.

INTRODUCTION: Natural orifice translumenal endoscopic surgery (NOTES) is a rapidly evolving field that provides endoscopic access to the peritoneum via a natural orifice. One important requirement of this technique is the need to minimize the risk of clinically significant peritoneal contamination. We report the bacterial load and contamination of the peritoneal cavity in ten patients who underwent diagnostic transgastric endoscopic peritoneoscopy. METHODS: Patients participating in this trial were scheduled to undergo diagnostic laparoscopy for evaluation of presumed pancreatic cancer. Findings at diagnostic laparoscopy were compared with those of diagnostic transgastric endoscopic peritoneoscopy, using an orally placed gastroscope, blinding the endoscopist to the laparoscopic findings. We performed no gastric decontamination. Diagnostic findings, operative times, and clinical course were recorded. Gastroscope and peritoneal fluid aspirates were obtained prior to and after the gastrotomy. Each sample was sent for bacterial colony counts, culture, and identification of species. RESULTS: Ten patients, with an average age of 63.7 years, have completed the protocol. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic peritoneoscopy. The average time for laparoscopy was 7.2 min, compared with 18 min for transgastric instrumentation. Bacterial sampling was obtained in all ten patients. The average number of colony-forming units (CFU) in the gastroscope aspirate was 132.1 CFU/ml, peritoneal aspirates prior to creation of a gastrotomy showed 160.4 CFU/ml, and peritoneal sampling after gastrotomy had an average of 642.1 CFU/ml. There was no contamination of the peritoneal cavity with species isolated from the gastroscope aspirate. No infectious complications or leaks were noted at 30-day follow-up. CONCLUSIONS: There was no clinically significant contamination of the peritoneal cavity from the gastroscope after transgastric endoscopic instrumentation in humans. Transgastric instrumentation does contaminate the abdominal cavity but, the pathogens do not mount a clinically significant response in terms of either the species or the bacterial load.

Clusterin Impairs Hepatic Insulin Sensitivity and Adipocyte Clusterin Associates With Cardiometabolic Risk.

OBJECTIVE: Components of the adipose tissue (AT) extracellular matrix (ECM) are recently discovered contributors to obesity-related cardiometabolic disease. We identified increased adipocyte expression of ECM-related clusterin (apolipoprotein J) in obese versus lean women by microarray. Our objective was to determine 1) whether subcutaneous AT adipocyte (SAd) clusterin and serum clusterin are associated with insulin resistance (IR) and known markers of cardiometabolic risk and 2) how clusterin may contribute to increased risk. RESEARCH DESIGN AND METHODS: We validated increased clusterin expression in adipocytes from a separate group of 18 lean and 54 obese individuals. The relationship of clusterin gene expression and plasma clusterin with IR, cardiovascular biomarkers, and risk of cardiovascular disease (CVD) was then determined. Further investigations in human cultured cells and in aged LDLR-/- mice prone to development of obesity-associated complications were performed. RESULTS: SAd clusterin correlated with IR, multiple CVD biomarkers, and CVD risk, independent of traditional risk factors. Circulating human clusterin exhibited similar associations. In human adipocytes, palmitate enhanced clusterin secretion, and in human hepatocytes, clusterin attenuated insulin signaling and APOA1 expression and stimulated hepatic gluconeogenesis. LRP2 (megalin), a clusterin receptor, highly expressed in liver, mediated these effects, which were inhibited by LRP2 siRNA. In response to Western diet feeding, an increase in adipocyte clusterin expression was associated with a progressive increase in liver fat, steatohepatitis, and fibrosis in aged LDLR-/- mice. CONCLUSIONS: Adipocyte-derived clusterin is a novel ECM-related protein linking cardiometabolic disease and obesity through its actions in the liver.

Gastrotomy closure using bioabsorbable plugs in a canine model.

The repair of gastric perforation commonly involves simple suture closure using an open or laparoscopic approach. An endolumenal approach using prosthetic materials may be beneficial. The role of bioprosthetics in this instance has not been thoroughly investigated, thus the authors evaluated the feasibility of gastric perforation repair using a bioabsorbable device and quantified gross and histological changes at the injury site. Twelve canines were anesthetized and underwent open gastrotomy. A 1-cm-diameter perforation was created in the anterior wall of the stomach and plugged with a bioabsorbable device. Intralumenal pH was recorded. Canines were sacrificed at one, four, six, eight, and 12 weeks. The stomach was explanted followed by gross and histological examination. The injury site was examined. The relative ability of the device to seal the perforation was recorded, as were postoperative changes. Tissue samples were analyzed for gross and microscopic tissue growth and compared to normal gastric tissue in the same animal as an internal control. A scoring system of -2 to +2 was used to measure injury site healing (-2= leak, -1= no leak and minimal ingrowth, 0= physiologic healing, +1= mild hypertrophic tissue, +2= severe hypertrophic tissue). In all canines, the bioprosthesis successfully sealed the perforation without leak under ex vivo insufflation. At one week, the device maintained its integrity but there was no tissue ingrowth. Histological healing score was -1. At 4-12 weeks, gross examination revealed a healed injury site in all animals. The lumenal portion of the plug was completely absorbed. The gross and histological healing score ranged from -1 to +1. The application of a bioabsorbable device results in durable closure of gastric perforation with physiologic healing of the injury site. This method of gastrotomy closure may aid in the evolution of advanced endoscopic approaches to perforation closure of hollow viscera.

Natural-orifice transgastric endoscopic peritoneoscopy in humans: Initial clinical trial.

BACKGROUND: Natural-orifice translumenal endoscopic surgery (NOTES) is a possible advancement for surgical interventions. We initiated a pilot study in humans to investigate feasibility and develop the techniques and technology necessary for NOTES. Reported herein is the first human clinical trial of NOTES, performing transoral transgastric diagnostic peritoneoscopy. METHODS: Patients were scheduled to undergo diagnostic laparoscopic evaluation of a pancreatic mass. The findings of traditional laparoscopy were recorded by anatomical abdominal quadrant. A second surgeon, blinded to the laparoscopic findings, performed transgastric peritoneoscopy. Diagnostic findings between the two methods were compared and operative times and clinical course were recorded. Definitive care was based on findings at diagnostic laparoscopy. RESULTS: Ten patients completed the protocol with an average age of 67.6 years. All patients underwent diagnostic laparoscopy followed by successful transgastric access and diagnostic endoscopic peritoneoscopy. The average time of diagnostic laparoscopy was 12.3 minutes compared to 24.8 minutes for the transgastric route. Transgastric abdominal exploration corroborated the decision to proceed to open exploration made during traditional laparoscopic exploration in 9 of 10 patients. Peritoneal or liver biopsies were obtained in four patients by traditional laparoscopy and in one patient by the transgastric access route. Findings were confirmed by laparotomy in nine patients. Eight patients underwent pancreaticoduodenectomy and two underwent palliative gastrojejunostomy and/or hepaticojejunostomy. CONCLUSIONS: Transgastric diagnostic peritoneoscopy is safe and feasible. This study demonstrates the initial steps of NOTES in humans, providing a potential platform for incisionless surgery. Technical issues, including instrumentation, visualization, intra-abdominal manipulation, and gastric closure need further development.

Transgastric instrumentation and bacterial contamination of the peritoneal cavity.

INTRODUCTION: Natural orifice transluminal endoscopic surgery (NOTES) is a rapidly evolving technique providing access to the peritoneum utilizing an endoscope via a natural orifice. One of the most significant requirements of this technique is the need to minimize the risk of clinically significant peritoneal contamination. We report the bacterial load and contamination of the peritoneal cavity in patients requiring a gastrotomy Roux-en-Y gastric bypass (LSRYGB). METHODS: We prospectively studied 50 patients undergoing a gastrotomy with creation of a gastrojejunostomy during LSRYGB. We recorded the patient's proton-pump inhibitor (PPI) utilization preoperatively and sampled gastric contents without lavage. We also sampled peritoneal fluid prior to and after gastrotomy, noting the length of time the gastrotomy was open to the peritoneum. Each of the three samples was sent for bacterial colony counts, and culture with identification of species. RESULTS: Fifty patients underwent LSRYGB with a mean operative time of 93 min. The gastrotomy was open to the peritoneal cavity for an average of 18 min. Seventeen of 50 patients were on PPIs preoperatively, resulting in a significant difference in postgastrostomy peritoneal bacterial counts. The average number of colony-forming units (CFU) of the gastric aspirate was 22,303 CFU/ml. Peritoneal aspirates obtained for examination prior to creation of a gastrotomy showed no CFUs in 44 of 50 patients. Peritoneal sampling after gastrotomy showed contamination of the abdomen with an average of 1102 CFU/ml. There was no correlation between the bacterial load in the stomach and peritoneal load after gastrotomy. No infectious complications or leaks developed. One complication of rhabdomyolysis in a patient with no peritoneal bacterial contamination developed. CONCLUSIONS: Transgastric instrumentation does contaminate the abdominal cavity but pathogens are clinically insignificant due to species or bacterial load. Patients on PPIs do have an increased bacterial load in the gastric aspirate, with no clinical significant infection.

Adipocyte DIO2 Expression Increases in Human Obesity but Is Not Related to Systemic Insulin Sensitivity.

Deiodinase type II (D2), encoded by DIO2, catalyzes the conversion of T4 to bioactive T3. T3 not only stimulates adaptive thermogenesis but also affects adipose tissue (AT) lipid accumulation, mitochondrial function, inflammation, and potentially systemic metabolism. Although better defined in brown AT, the precise role of DIO2 expression in white AT remains largely unknown, with data derived only from whole fat. Therefore, the purpose of this study was to determine whether subcutaneous (SAT) and visceral (VAT) adipocyte-specific gene expression of DIO2 differs between obese and lean patients and whether these differences relate to alterations in mitochondrial function, fatty acid flux, inflammatory cytokines/adipokines, and ultimately insulin sensitivity. Accordingly, adipocytes of 73 obese and 21 lean subjects were isolated and subjected to gene expression analyses. Our results demonstrate that obese compared to lean human individuals have increased adipocyte-specific DIO2 expression in both SAT and VAT. Although higher DIO2 was strongly related to reduced fatty acid synthesis/oxidation and mitochondrial function, we found no relationship to proinflammatory cytokines or insulin resistance and no difference based on diabetic status. Our results suggest that adipocyte-derived DIO2 may play a role in weight maintenance but is likely not a major contributor to obesity-related insulin resistance.