Establishing consensus on the perioperative management of cholecystectomy in public hospitals: a Delphi study with an expert panel in Mexico.

BACKGROUND: Several guidelines have put forward recommendations about the perioperative process of cholecystectomy. Despite the recommendations, controversy remains concerning several topics, especially in low- and middle-income countries. The aim of this study was to develop uniform recommendations for perioperative practices in cholecystectomy in Mexico to standardize this process and save public health system resources. METHODS: A modified Delphi method was used. An expert panel of 23 surgeons anonymously completed two rounds of responses to a 29-item questionnaire with 110 possible answers. The consensus was assessed using the percentage of responders agreeing on each question. RESULTS: From the 29 questions, the study generated 27 recommendations based on 20 (69.0%) questions reaching consensus, one that was considered uncertain (3.4%), and six (20.7%) items that remained open questions. In two (6.9%) cases, no consensus was reached, and no recommendation could be made. CONCLUSIONS: This study provides recommendations for the perioperative management of cholecystectomy in public hospitals in Mexico. As a guide for public institutions in low- and middle-income countries, the study identifies recommendations for perioperative tests and evaluations, perioperative decision making, postoperative interventions and institutional investment, that might ensure the safe practice of cholecystectomy and contribute to conserving resources.

Profiling Lung Cancer Patients Using Electronic Health Records.

If Electronic Health Records contain a large amount of information about the patient's condition and response to treatment, which can potentially revolutionize the clinical practice, such information is seldom considered due to the complexity of its extraction and analysis. We here report on a first integration of an NLP framework for the analysis of clinical records of lung cancer patients making use of a telephone assistance service of a major Spanish hospital. We specifically show how some relevant data, about patient demographics and health condition, can be extracted; and how some relevant analyses can be performed, aimed at improving the usefulness of the service. We thus demonstrate that the use of EHR texts, and their integration inside a data analysis framework, is technically feasible and worth of further study.

Intravenous acetaminophen in bariatric surgery: effects on opioid requirements.

BACKGROUND: Opioids are commonly used after bariatric surgery for pain control because of their potent analgesic effects. Nevertheless, the morbidly obese patient has increased risk for developing adverse effects produced by opioids (such as sedation, apnea, hypoxemia, ileus, and vomiting). Intravenous acetaminophen (IVA) has been evaluated in some specialties showing a reduction in opioid consumption. The purpose of this study was to evaluate the effect on opioid consumption when IVA is administered in bariatric surgery patients. MATERIAL AND METHODS: A retrospective study was performed in patients who underwent bariatric surgery. Group A included those patients who received IVA perioperatively and group B those who did not. The amount of opioids administered was calculated and compared for each group. RESULTS: Group A included 38 cases (44.7%) and group B included 47 cases (55.3%). A comparison was performed in terms of age (P = 0.349), body mass index (P = 0.311), gender (P = 0.890), American Society of Anesthesiologist score (P = 0.438), total surgical time (P = 0.497), perioperative complications (P = 0.786), number of procedures per surgeon (P = 0.08), and type of surgical procedure (P ≤ 0.01). Group A had a mean 24-h total opioid dose of 99.5 mg, whereas group B of 164.6 mg (P = 0.018). Group A received 39.5% less opioids than group B. A post hoc analysis determined a statistical power of 0.74. CONCLUSIONS: IVA used perioperatively can decrease opioid consumption in patients after bariatric surgery. Randomized trials are needed to corroborate these results.

Single-incision cholecystectomy: a comparative study of standard laparoscopic, robotic, and SPIDER platforms.

BACKGROUND: Many series have shown the feasibility and safety of single-incision laparoscopic cholecystectomy (SILC), but this technique still has limitations such as instrument collisions and lack of triangulation. Recently, two single-incision platforms, robotic and SPIDER, have attempted to ameliorate such problems. This study aimed to compare three different techniques of single-incision cholecystectomy: standard laparoscopic, robotic, and SPIDER approaches. METHODS: The authors retrospectively collected data from their first 166 single-incision robotic cholecystectomies (SIRCs) and compared the findings with the data from their first 166 SILCs and the first 166 s-generation SPIDER procedures. All the SILCs were performed with three trocars placed in one umbilical incision and with gallbladder retraction using a Prolene stitch on the right upper quadrant. All the robotic cases were managed using the da Vinci Single-Site Surgical System, and all the SPIDER procedures were performed using the SPIDER Surgical System. RESULTS: The SILC, SIRC, and SPIDER groups consisted respectively of 129 (76.3%), 131 (78.9%), and 136 (81.9%) women with the respective mean ages of 44.5 ± 14.3, 51.6 ± 15.9, and 46.4 ± 15.2 years. The mean body mass indexes (BMIs) were respectively 29.1 ± 5.6, 29.4 ± 6.2, and 27.5 ± 4.8 kg/m(2), and the mean surgical times were 37.1 ± 13.3, 63.0 ± 25.2, and 52.8 ± 18.7 min. The total hospital stays were respectively 1.3 ± 5.3, 1.2 ± 2.2, and 1.5 ± 2.6 days, and complications were seen respectively in three SILC cases (1.8%), three SIRC cases (1.8%), and two SPIDER cases (1.2%). CONCLUSIONS: The results of this study demonstrate similar results among the three platforms for most of the parameters measured. The SILC procedure appears to be superior to SIRC and SPIDER in terms of surgical time, but selection bias could be the cause. The SILS, SIRC, and SPIDER procedures all are similar in terms of complication profile. It can be concluded that SILC, SIRC, and SPIDER all are feasible and safe alternatives when used for single-incision cholecystectomy.

Synergistic effect of alcohol consumption and body mass on serum concentrations of cytokeratin-18.

BACKGROUND: Cytokeratin-18 is an essential component of the cytoskeleton of epithelial cells (including hepatocytes). Serum concentrations of cytokeratin-18 (tissue polypeptide-specific antigen [TPS]) are used as a marker of epithelial neoplasms. Here, we investigated the potential interaction between alcohol and obesity in relation to serum TPS concentrations. METHODS: Alcohol consumption, body mass index, and components of metabolic syndrome were measured in a random sample (n = 420) of the adult population (aged 18 to 92 years, 45% men) from a single municipality. Regular alcohol intake of >20 g/d (women) or >30 g/d (men) was considered risky drinking. Serum TPS was measured with a commercial immunoassay. RESULTS: Risky drinking was associated with increased serum concentrations of TPS, which was particularly evident among obese individuals. Among individuals without risky drinking, TPS concentrations were similar for all levels of body mass. Conversely, among risky drinkers, serum TPS concentrations increased in parallel with body mass (p = 0.002). The odds ratio of a high (>100 U/l) TPS concentration for the combination of risky drinking and obesity was greater than the additive effect of the 2 separate factors, after adjusting for age and sex. A similar interaction was observed between risky drinking and abdominal adiposity, a major component of the metabolic syndrome. Serum TPS concentrations were correlated with markers of liver damage. Serum TPS was not superior to standard markers (gamma-glutamyl transferase and red blood cell mean volume) for the detection of risky drinking. CONCLUSIONS: There is a synergism between risky alcohol consumption and common metabolic disorders (particularly obesity) in relation to serum concentrations of cytokeratin-18 (TPS), which probably reflect liver disease.

Single Anastomosis Sleeve Ileal Bypass (SASI Bypass): Short-Term Outcomes and Concerns.

BACKGROUND: Single anastomosis sleeve ileal (SASI) Bypass has recently emerged as a novel surgical technique. The purpose of this study is evaluating the efficacy and feasibility of our SASI technique. METHODS: Between April 2018 and February 2020, 83 patients underwent SASI bypass at our center. A retrospective analysis was performed. Forty-three patients (51.8%) completed follow-up at 12 months. RESULTS: Average BMI at 12 months, change in BMI, and %EWL were 28.2 ± 4.5 kg/m2, 13.5 ± 5.7 kg/m2, and 85.6% respectively. From the 25 patients evaluated, diabetes remission occurred in 95.8% of them. There were 4 (4.8%) Clavien-Dindo (CD) I, 5 (6.0%) CD II, and 2 (2.4%) CD IIIb complications. CONCLUSIONS: SASI bypass offers excellent weight loss and comorbidities resolution. As expected, higher-quality studies are needed.

Vitamin D serum levels and non-melanoma skin cancer risk.

BACKGROUND: Skin cancer is one of the common malignancies. There is sufficient evidence that sunlight (ultraviolet radiation) contributes to the development of skin cancer, but there is also evidence that relates adequate serum levels of vitamin D produced on the skin by the action of ultraviolet radiation with the decreased risk of various types of cancers, including skin cancer. The aim of this study was to investigate the association of vitamin D serum levels among patients with non-melanoma skin cancers (basal cell carcinoma and squamous cell carcinoma) and controls. METHODS: A prospective observational case-control study was conducted in a sample of 84 subjects in Extremadura (Spain). Forty-one patients with histologically diagnosed basal cell carcinomas and squamous cell carcinomas and 43 healthy controls were randomly chosen to assess whether vitamin D (25(OH)D3) serum level, age and sex were related to non-melanoma skin cancer and to determine the possible risk of this type of skin cancer for these variables. RESULTS: When analysing serum vitamin D levels, we ensured that all our subjects, both cases and controls, had normal or low serum vitamin D levels, even though the samples were taken during months with the highest solar irradiance in our region. It is striking in our results that there was a higher percentage of subjects with deficits of vitamin D who did not have skin cancer (66%) than patients with deficits with these types of skin cancers (34%). When adjusting the model for age and sex, vitamin D values above 18 ng/ml increased the risk of suffering from non-melanoma skin cancer by nearly 7-fold (aOR: 6.94, 95% CI [1.55-31.11], p = 0.01). CONCLUSIONS: Despite the controversial data obtained in the literature, our results suggest that lower levels of vitamin D may be related to a reduced incidence of non-melanoma skin cancer.

Factors influencing serum total tryptase concentrations in a general adult population.

BACKGROUND: Serum tryptase measurements are increasingly being used in clinical practice. However, there is a paucity of studies focused on factors that influence tryptase concentrations. We investigated the relationships between total tryptase concentrations and age, gender, atopy, alcohol consumption, smoking, and common metabolic abnormalities in adults. METHODS: This was a cross-sectional study of a random sample from an adult population (n=420, age 18-92 years, 45% males) from a single municipality. Serum total tryptase was measured using a fluoro-enzyme immunoassay. RESULTS: The median tryptase concentration was 5.1 microg/L (range, <1-30.7 microg/L). There was a significant (p<0.0001) continual increase in tryptase with age; the median concentrations were 4.0 microg/L in 18-30 years old and 6.6 microg/L in those >80 years. Female gender and heavy ethanol use were negatively and independently associated with tryptase concentrations. Tryptase was higher in individuals that were non-atopic, overweight, or had metabolic syndrome compared to individuals that were atopic, normal weight, or did not have the metabolic syndrome. However, these associations were attenuated after adjusting for age. CONCLUSIONS: Serum total tryptase concentrations in adults are not significantly modified by atopy status, but may be modified by lifestyle factors, such as alcohol consumption and gender. Serum total tryptase concentrations are particularly dependent on age.

Gastro-ileal anastomosis bypass - Exploring for an expanding surgical treatment for diabetes in patients with low body mass index: Case series.

INTRODUCTION: Several metabolic operations have been created in an attempt to enhance the equilibrium between safety, efficacy and costs of accessible metabolic surgery in diabetic patients with low body mass index (BMI). The purpose of this study is to present the preliminary outcomes of a novel procedure. METHODS: A Gastro-Ileal Anastomosis Bypass (GIA-B) was performed in 4 diabetic patients at Boca del Rio Hospital, Veracruz, México. The study was performed between March 2018 and October 2019. GIA-B was created at point to 300 cm from ileocecal valve that was held together with gastric antrum. Outcomes are presented and discussed. At average 14.7 months follow-up all the patients improved glycated hemoglobin(A1C), decrease antidiabetic medications and lost mild weight. Two patients had complete remission of type-2 diabetes mellitus. There were no postoperative complications. RESULTS: GIA-B, have a considerable metabolic effect reaching improvement of the homeostatic parameters, specially A1C, in all the cases evaluated. GIA-B appears to be technically simple and the cost is considerably lower than other metabolic procedures, especially for the saving cartridges. CONCLUSIONS: GIA-B could be an alternative metabolic surgery for low-BMI diabetic patients, further studies are needed to explore this procedure.

Adherence to a Mediterranean Diet and Bone Mineral Density in Spanish Premenopausal Women.

The Mediterranean diet (MD) has been associated with an improvement in health and an increase in longevity. Certain components of a MD can play a role in the prevention of osteoporosis and/or hip fracture. We investigated the association between the degree of adherence to a MD and bone mineral density (BMD) measured in several bone areas in a population of Spanish premenopausal women. We analyzed 442 premenopausal women aged 42.73 ± 6.67 years. Bone measurements were obtained using quantitative bone ultrasound (QUS) for the phalanx, dual energy X-ray absorptiometry (DXA) for the lumbar spine, Ward's triangle, trochanter, and hip, and peripheral quantitative computed tomography (pQCT) for the non-dominant distal forearm. MD adherence was evaluated with MedDietScore. Amplitude-dependent speed of sound (Ad-SOS), BMD, and volumetric bone mineral density (vBMD) (total, trabecular, and cortical bone density) were positively associated with higher adherence to the MD (p < 0.05). Adherence to the MD was significantly associated with QUS, BMD, and vBMD in multiple regression analysis; QUS: Ad-SOS (m/s) ß = 0.099 (p = 0.030); BMD (g/cm²): femur neck ß = 0.114 (p = 0.010) and Ward's triangle ß = 0.125 (p = 0.006); vBMD (mg/cm³): total density ß = 0.119 (p = 0.036), trabecular density ß = 0.120 (p = 0.035), and cortical density ß = 0.122 (p = 0.032). We conclude that the adherence to the MD was positively associated with better bone mass in Spanish premenopausal women.

A comparison of prospective and retrospective assessment of functional outcome after rotator cuff repair.

Prospective outcome studies are generally considered to be better than retrospective studies. The purpose of this study was to assess correlations between prospective and retrospective outcome assessment after rotator cuff repair. One-hundred and twelve patients (118 shoulders) with chronic rotator cuff tears were evaluated at a mean of 54 months (34-85) after rotator cuff repair, using several outcome measures including a retrospective assessment of improvement. The retrospective assessment of post-operative pain, function, and quality of life had fair correlations with the prospectively determined improvement (R = .23-.25, P < .01). Post-operative patient satisfaction was more highly correlated with all retrospective evaluations than with the prospective improvement in all functional outcome measures. Retrospective and prospective evaluations of the outcome of rotator cuff repair are different. Patient satisfaction has a greater correlation with retrospective outcomes. Retrospective evaluation may aid in supplementing prospective evaluations, as it may better reflect a patient's perception of the success after surgery.

Quantification of meniscal volume by segmentation of 3T magnetic resonance images.

Meniscal injuries place the knee at risk for early osteoarthritis (OA) because they disrupt their load-bearing capabilities. Partial resection is routinely performed to alleviate symptomatic meniscal tears. While the removal of meniscal tissue may not be the only factor associated with partial meniscectomy outcome, the amount removed certainly contributes to functional loss. It is unknown, however, whether there is a critical amount of meniscal tissue that can be removed without diminishing the structure's chondroprotective role. In order to examine the existence of such a threshold, it is necessary to accurately quantify meniscal volume both before and after partial meniscectomy to determine the amount of meniscal tissue removed. Therefore, our goal was to develop and validate an MR-based method for assessing meniscal volume. The specific aims were: (1) to evaluate the feasibility of the MR-based segmentation method; (2) to determine the method's reliability for repeated measurements; and (3) to validate its accuracy in situ. MR images were obtained on a 3T magnet, and each scan was segmented using a biplanar approach. The MR-based volumes for each specimen were compared to those measured by water displacement. The results indicate that the biplanar approach of measuring meniscal volumes is accurate and reliable. The calculated volumes of the menisci were within 5% of the true values, the coefficients of variation were 4%, and the intraclass correlation coefficients were greater than 0.96. These data demonstrate that this method could be used to measure the amount of meniscal tissue excised during partial meniscectomy to within 125.7 mm(3).

Factors influencing patient satisfaction after rotator cuff repair.

A number of variables are used to assess the outcome of rotator cuff repair (RCR), including patient satisfaction. The purpose of this study was to determine the factors that affect patient satisfaction after RCR. The study assessed 112 patients (118 shoulders) with chronic rotator cuff tears preoperatively and at a mean of 54 months (range, 34-85 months) after RCR by using several functional outcome questionnaires and an evaluation of patient satisfaction. Of these, 95% were satisfied with the outcome of the surgery. Satisfaction was significantly correlated with the improvement in functional outcomes and general health status and absolute postoperative functional outcomes. Married, currently working, and nondisabled patients had greater satisfaction. High preoperative and postoperative met expectations were also positively correlated with patient satisfaction. Patient satisfaction is most highly correlated with the pain, function, and general health status of the patient after RCR. We conclude that aspects of treatment that maximize the functional outcome are important in achieving patient satisfaction after RCR.

Laparoscopic ventral hernia repair with primary closure versus no primary closure of the defect: potential benefits of the robotic technology.

BACKGROUND: Some authors recommend primary closure of the defect before placement of the mesh. The purpose of this study is to compare laparoscopic ventral hernia repair (LVHR) without primary closure of the defect (NPCD) versus LVHR with primary closure of the defect (PCD). METHODS: A retrospective review of 134 LVHR was performed. Each group included 67 cases. For the PCD group the robotic platform was used. RESULTS: Groups were similar in terms of demographics and comorbidities. For NPCD and PCD groups mean surgical time was 87.9±53.1 and 107.6±33.9 minutes (p = 0.012); conversion to open surgery was seen in 3(4.5%) and 1(1.5%) (p = 0.310); complications were 7(10.4%) and 2(3%) (p = 0.084); and finally, recurrences were seen in 5(7.5%) and 1(1.5%) (p = 0.095). CONCLUSIONS: PCD has longer surgical time, however, a tendency in terms of complications and recurrences was found favoring the PCD group. The robotic assistance is a good alternative when primary closure of the defect is attempted.

A comparative retrospective study of robotic sleeve gastrectomy vs robotic gastric bypass.

BACKGROUND: The introduction of the robotic platform to bariatric surgery has brought forth a novel approach, with modifications to the standard laparoscopic sleeve gastrectomy (LSG) and laparoscopic gastric bypass (LGB). The purpose of this study was to match robotic gastric bypass (RGB) vs robotic sleeve gastrectomy (RSG) and compare them to those observed with the laparoscopic platform. METHODS: A retrospective data collection of RSGs and RGBs from a single institution was performed. Groups were compared. RESULTS: This study included 134 RSG and 165 RGB patients. RGB has a longer surgical time (p < 0.001) and a higher incidence of long-term complications (p = 0.005) but similar lengths of hospital stay (p = 0.093), rate of perioperative complications (p = 0.487) and EWL% at 1 year of follow-up compared to RSG. CONCLUSIONS: RSGs had shorter surgical times and a lower incidence of long-term complications when compared with RGBs. These results appear to be similar to those studies reporting the laparoscopic approach. Copyright © 2014 John Wiley & Sons, Ltd.

Impact of fellowship during single-incision laparoscopic cholecystectomy.

BACKGROUND AND OBJECTIVES: Minimally invasive surgery fellowship programs have been created in response to advancements in technology and patient's demands. Single-incision laparoscopic cholecystectomy (SILC) is a technique that has been shown to be safe and feasible, but this appears to be the case only for experienced surgeons. The purpose of this study is to evaluate the impact of minimally invasive surgery fellow participation during SILC. METHODS: We reviewed data from our experience with SILC during 3 years. The cases were divided in two groups: group 1 comprised procedures performed by the main attending without the presence of the fellow, and group 2 comprised procedures performed with the fellow present during the operation. Demographic characteristics, comorbidities, indication for surgery, total surgical time, hospital length of stay, and complications were evaluated. RESULTS: The cohort included 229 patients: 142 (62%) were included in group 1 and 87 (38%) in group 2. No differences were found in demographic characteristics, comorbidities, and indication for surgery between groups. The total surgical time was 34.4 ± 11.4 minutes for group 1 and 46.8 ± 16.0 minutes for group 2 (P < .001). The hospital length of stay was 0.89 0.32 days for group 1 and 1.01 ± 0.40 days for group 2 (P = .027). No intraoperative complications were seen in either group. There were 3 postoperative complications (2.1%) in group 1 and none in group 2 (P = .172). CONCLUSION: Adoption of SILC during an established fellowship program is safe and feasible. A longer surgical time is expected during the teaching process.

Robotic sleeve gastrectomy: experience of 134 cases and comparison with a systematic review of the laparoscopic approach.

BACKGROUND: Robotic technology has recently emerged in different surgical specialties, but the experience with robotic sleeve gastrectomy (RSG) is scarce in the literature. The purpose of this study is to compare our preliminary experience with RSG versus the descriptive results of a systematic review of the laparoscopic approach. METHODS: Data from our RSG experience were retrospectively collected. Two surgeons performed all the cases in one single surgery center. Such information was compared with a systematic review of 22 selected studies that included 3,148 laparoscopic sleeve gastrectomy (LSG) cases. RSG were performed using the daVinci Surgical System. RESULTS: This study included 134 RSG vs. 3,148 LSG. Mean age and mean BMI was 43 ± 12.6 vs. 40.7 ± 11.6 (p = 0.022), and 45 ± 7.1 vs. 43.6 ± 8.1 (p = 0.043), respectively. Leaks were found in 0 RSG vs. 1.97% LSG (p = 0.101); strictures in 0 vs. 0.43% (p = 0.447); bleeding in 0.7 vs. 1.21% (p = 0.594); and mortality in 0 vs. 0.1% (p = 0.714), respectively. Mean surgical time was calculated in 106.6 ± 48.8 vs. 94.5 ± 39.9 min (p = 0.006); and mean hospital length of stay was 2.2 ± 0.6 vs. 3.3 ± 1.7 days (p = <0.005), respectively. Four (2.9%) complications were found in our robotic series. CONCLUSIONS: Our series shows that RSG is a safe alternative when used in bariatric surgery, showing similar results as the laparoscopic approach. Surgical time is longer in the robotic approach, while hospital length of stay is lower. No leaks or strictures were found in the robotic cases. However, further studies with larger sample size and randomization are warranted.

Robotic repair of giant paraesophageal hernias.

BACKGROUND AND OBJECTIVES: Giant paraesophageal hernia accounts for 5% of all hiatal hernias, and it is commonly seen in elderly patients with comorbidities. Some series report complication rates up to 28%, recurrence rates between 10% and 25%, and a mortality rate close to 2%. Recently, the da Vinci Surgical System (Intuitive Surgical, Sunnyvale, CA, USA) has shown equivocal benefits when used for elective surgeries, whereas for complex procedures, the benefits appear to be clearer. The purpose of this study is to present our preliminary experience in robotic giant paraesophageal hernia repair. METHODS: We retrospectively collected data from patients who had a diagnosis of giant paraesophageal hernia and underwent a paraesophageal hernia repair with the da Vinci Surgical System. RESULTS: Nineteen patients (12 women [63.1%]) underwent surgery for giant paraesophageal hernia at our center. The mean age was 70.4 ± 13.9 years (range, 40-97 years). The mean American Society of Anesthesiologists score was 2.15. The mean surgical time and hospital length of stay were 184.5 ± 96.2 minutes (range, 96-395 minutes) and 4.3 days (range, 2-22 days), respectively. Nissen fundoplications were performed in 3 cases (15.7%), and 16 patients (84.2%) had mesh placed. Six patients (31.5%) presented with gastric volvulus, and 2 patients had other herniated viscera (colon and duodenum). There were 2 surgery-related complications (10.5%) (1 dysphagia that required dilatation and 1 pleural injury) and 1 conversion to open repair (partial gastric resection). No recurrences or deaths were observed in this series. CONCLUSION: In our experience robotic giant paraesophageal hernia repair is not different from the laparoscopic approach in terms of complications and mortality rate, but it may be associated with lower recurrence rates. However, larger series with longer follow-up are necessary to further substantiate our results.

Giant Spiegelian hernia and abdominal trauma: cause or coincidence?

BACKGROUND: Spiegelian hernia is an uncommon entity and occurs as a result of a defect in the linea semilunaris located in the lateroventral abdominal wall. CLINICAL CASE: We report the case of a 44-year-old female with a history of progressive abdominal swelling. Clinical history included a previous blunt trauma to the abdomen. A Spiegelian hernia with a large aponeurotic defect (7 × 12 cm) and sac (15 × 15 cm) was diagnosed. A literature review of similar topics was performed. CONCLUSION: Weakness presented in the linea semilunaris in Spiegelian hernia may be caused either spontaneously or as a consequence of factors that increase intra-abdominal pressure. Otherwise, it is important to unify the terms related to the size of this entity in order to establish a correct classification.