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Summary: Background: There are conflicting results concerning the bariatric effectiveness of adjustable gastric banding in super-obese patients with a Body Mass Index (BMI) more or equal to 50kg/m2. Method: A cohort of 186patients with a BMI greater or equal to 50kg/m2 who underwent adjustable gastric banding (AGB) at the Bichat–Claude-Bernard University Hospital (Paris, France) were prospectively entered into a database. The following data were recorded: BMI, percentage of BMI loss, percentage of excess weight lost (%EWL), complications, and surgical re-interventions. Loss of greater than 50% of excess weight was considered a success (primary endpoint). A %EWL of less than 25% after one year, or the removal of the gastric band was considered a failure. Results: Thirty-five men (18.8%) and 151women (81.2%), with a mean age of 38.9years (range: 16–65) underwent AGB between September 1995 and December 2007. The mean BMI was 55.06kg/m2 (range: 50–74.4). Mean follow-up was 112.5months with a minimum of 28months and a maximum of 172months. The follow-up rate was maintained at 89% at ten years. The technique of AGB was by “peri-gastric dissection” in the first 115patients (61.82%) and by “pars flaccida dissection” in 71patients (38.17%). The gastric band was removed in 87 of 186patients (46.8%); band ablation was due to a complication of the gastric band in 62 of these cases (33.3%), to failure of weight loss in 23cases (12.4%), and to patient request in two cases (1%). The major complications requiring re-operation were: chronic dilatation of the proximal gastric pouch (27patients – 14.5%), acute dilatation (21patients – 11.3%), intragastric migration of the prosthesis (six patients – 3.2%), reflux esophagitis (six patients – 3.2%), infection of the gastric band (one patient – 0.5%), and Barrett''s esophagus (one patient – 0.5%). No statistically significant difference was found between the two operative techniques with regard to the possibility of preserving the gastric band for ten years. For patients who underwent band removal, no further follow-up analysis of patient data after band ablation was performed. The results were best at two years after AGB with a median BMI of 42.72kg/m2, a band removal rate of 8.6% (16 of 186patients), and a failure rate of 16.4% (28 of 170patients) of those patients who still had their band in place. However, at 10years, the picture was completely reversed with a band removal rate of 52.2% (47 of 90patients), a failure rate of 22% (seven of 33patients) of those who still had their band in place, and a median BMI of 43.43kg/m2. Conclusion: Laparoscopic gastroplasty using the adjustable gastric band appeared to be a promising intervention for super-obese patients when the results at two years were analyzed – fairly simple to perform, with perioperative morbidity and mortality near zero. However, these results do not persist in the long-term for super-obese patients. At ten years, only 11% of patients (nine of 80) have successful bariatric results (%EWL>50%) and we were forced to remove the gastric band in 52.2% of patients (47 of 90) because of complications, regardless of the initial operative technique used. Given these results, AGB gastroplasty is not a recommended method for super-obese patients and we believe that a BMI greater or equal to 50kg/m2 is a contra-indication for this procedure. [Copyright &y& Elsevier]

Introduction: Weight loss after bariatric surgery causes very important modifications to the patient's silhouette. Abdominal fat and skin excess reduction are associated with several complications. The most frequent are seroma and hematoma whereas major complications, such as pulmonary embolism, are less frequent. This study aimed to describe our technical procedure for abdominoplasty in patients with massive weight loss after bariatric surgery., Methods: In total, 196 patients were included. All patients who underwent abdominoplasty classic (group A) and abdominoplasty with the preservation and lift of Scarpa fascia (group B) and with umbilical transposition between May 2018 and May 2021 were included. Patients with concomitant correction of ventral hernia were excluded. Demographic and operative data were analyzed according to comorbidities and postoperative complications., Results: There were 160 (81.6%) women. The mean age was 43.6 years; the mean weight was 86.7 kg; and the mean BMI was 28.6 kg/m 2 . Five patients (2.5%) presented postoperative seroma. Four patients (2%) presented partial dehiscence/skin necrosis one of them requiring a revision. Finally, 26 patients presented a postoperative complication, with an overall incidence of 12.6%. The average postoperative hospital stay was 3.6. The rates of seroma were significantly higher in men, patients with a BMI > 30 kg/m 2 , and aged >50 years., Conclusion: Preserving Scarpa Fascia during surgical post-bariatric patient procedures reduces the seroma formation and the scar complication and reduces the tension of the inguinal-pubic region with correction of our deformation after weight loss. Improves reducing the drain and reducing seroma incidence suction and hospital stay., Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision., (© 2024 Cannistrà, Lori, Arapis, Gallo, Varanese, Pironi, De Luca, Frusone, Amabile, Sorrenti, Gagliardi and Tripodi.)

Bariatric surgery (BS) is rarely performed on patients aged 70 and over, due to the fear of adverse effects, particularly related to sarcopenia. We examined the outcome of obese patients who underwent BS after the age of 69 in the French population. Operated subjects were matched with non-operated obese patients (n = 1307 in each group after matching). We showed that BS was associated with a reduction in mortality and no increase in the risks of rehospitalization or fracture events., (© 2023. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Gastric sleeve stenosis (GSS) is described in 1%-4% of patients., Objective: To evaluate the role of endoscopy in the management of stenosis after laparoscopic sleeve gastrectomy using a standardized approach according to the characteristic of stenosis., Setting: Retrospective, observational, single-center study on patients referred from several bariatric surgery departments to an endoscopic referral center., Methods: We enrolled 202 patients. All patients underwent endoscopy in a fluoroscopy setting, and a systematic classification of the type, site, and length of the GSS was performed. According to the characteristics of the stenosis, patients underwent pneumatic dilatation or placement of a self-expandable metal stent or a lumen-apposed metal stent. Failure of endoscopic treatment was considered an indication for redo surgery, whereas patients with partial or complete response were followed up for 2 years. In the event of a recurrence, a different endoscopic approach was used., Results: We found inflammatory strictures in 4.5% of patients, pure narrowing in 11%, and functional stenosis in 84.5%. Stenosis was in the upper tract of the stomach in 53 patients, whereas medium and distal stenosis was detected in 138 and 11 patients, respectively, and short stenosis in 194 patients. A total of 126 patients underwent pneumatic dilatation, 8 self-expandable metal stent placement, 64 lumen-apposed metal stent positioning, and 36 combined therapy. The overall rate of endoscopy success was 69%., Conclusion: GSS should be considered to be a chronic disease, and the endoscopic approach seems to be the most successful treatment, with a prolonged positive outcome of 69%. Characteristics of the stenosis should guide the most suitable endoscopic approach., (Copyright © 2023 American Society for Metabolic and Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: Migration of the staple line is the definition of sliding hiatus hernia in sleeve gastrectomy patients. The main aim was to determine the frequency and measurement of intrathoracic staple line migration and its correlation with GERD symptoms and pH monitoring., Materials and Methods: This was a prospective clinical trial including all patients who underwent sleeve gastrectomy more than 1 year previously. All the patients underwent computed tomography (CT) imaging, and migration of the proximal end of the suture above the level of the hiatus was measured in mm. All the patients with symptoms suggestive of GERD were assessed using the GERD impact scale (GIS), and wireless 24-h esophageal pH and symptom association monitoring (SAP) were carried out. Analysis of risk factors for postoperative staple line migration was performed., Results: Between March 2018 and December 2018, 194 patients were evaluated (mean age 45.1 ± 11.2 years; 161 females); 88/194 (45.4%) presented an average intrathoracic migration of 16.2 ± 6.9 mm. Thirty-eight of 194 (19.5%) patients presented symptoms suggestive of gastroesophageal reflux. There was a significant relationship between staple line intrathoracic migration and postsleeve GERD symptomatology (p = 0.0004, OR = 4.25 [1.92-9.39]). However, there was no significant correlation between positive 24-h pH monitoring and intrathoracic migration of the staple line (p = 0.1)., Conclusion: A migration greater than 17 mm was strongly correlated with postsleeve GERD symptoms but not with positive 24-h pH monitoring., (© 2022. The Author(s), under exclusive licence to Springer Science+Business Media, LLC, part of Springer Nature.)

Background: Endoscopy plays a pivotal role in the management of adverse events (AE) following bariatric surgery. Leaks, fistulae, and post-operative collection after sleeve gastrectomy (SG) may occur in up to 10% of cases., Objectives: To evaluate the efficacy and safety of endoscopic internal drainage (EID) for the management of leak, fistula, and collection following SG., Setting: Retrospective, observational, single center study on patients referred from several bariatric surgery departments to an endoscopic referral center., Methods: EID was used as first-line treatment for the management of leaks, fistulae, and collections. Leaks and fistulae were treated with double pigtail stent (DPS) deployment in order to guarantee internal drainage and second intention cavity obliteration. Collections were treated with endoscropic ultrasound (EUS)-guided deployment of DPS or lumen apposing metal stents., Results: A total of 617 patients (83.3% female; mean age, 43.1 yr) were enrolled in the study for leak (n = 300, 48.6%), fistula (n = 285, 46.2%), and collection (n = 32, 5.2%). Median follow-up was 19.5 months. Overall clinical success was 84.7% whereas 15.3% of cases required revisional surgery after EID failure. Clinical success according to type of AE was 89.5%, 78.5%, and 90% for leak, fistula, and collection, respectively. A total of 10 of 547 (1.8%) presented a recurrence during follow-up. A total of 28 (4.5%) AE related to the endoscopic treatment occurred. At univariate logistic regression predictors of failure were: fistula (OR 2.012), combined endoscopic approach (OR 2.319), need for emergency surgery (OR 1.755), and previous endoscopic treatment (OR 4.818)., Conclusion: Early EID for the management of leak, fistula, and post-operative collection after SG seems a safe and effective first-line approach with good long-term results., (Copyright © 2021 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Purpose: In postoperative peritonitis, Gram stain examination (GSE) of peritoneal fluid has been proposed as a guide for the prescription of glycopeptides and antifungal therapy in empirical antibiotherapy. No data support this approach for Gram-positive cocci. We aimed to evaluate the performance of GSE in predicting the results of the culture of peritoneal fluid., Methods: In this retrospective single-center study, concordance between GSE and culture of peritoneal fluid was assessed for different types of microorganisms. Factors associated with concordance of the two tests were evaluated in the subpopulation of Gram-positive cocci peritonitis., Results: Among the 152 episodes, the GSE was negative in 57 cases. The negative predictive value and the positive predictive value were 41% and 87% for Gram-positive cocci (GPC), 31% and 86% for Gram-negative bacilli, and 78% and 94% for fungi. GSE is not a reliable guide for the choice of empirical antibiotherapy and cannot reliably rule out the presence of GPC at culture. If we aim to achieve a high rate of adequacy, the systematic use of glycopeptide in the empirical antibiotherapy may be considered., Conclusion: GSE shows poor performance to predict the results of culture of peritoneal fluid in postoperative peritonitis. Avoiding covering resistant GPC cannot be based on the result of GSE.

Background: Series comparing gastric banding (GB) removal and sleeve gastrectomy (SG) when procedures are performed as a 1- or a 2-step approach are contradictory in their outcomes. No series comparing these approaches with midterm weight loss is available., Objectives: Compare the outcomes and weight loss of SG performed as 1- and 2-step approaches as a revisional procedure for GB failure., Setting: University Hospital, France, public practice., Methods: Between February 2006 and January 2017, all patients undergoing SG with a previous history of implementation of GB (n = 358) were included in this 2-center, retrospective, observational study. Revisional surgery was proposed in patients with insufficient excess weight loss (excess weight loss ≤50%) or weight regain after GB. A 1-step (1-step group, n = 270) or 2-step (2-step group, n = 88) approach was decided depending on patient's choice and/or surgeon's preference. The primary efficacy endpoint was the comparison of weight loss in the 1- and 2-step groups at the 2-year follow-up. The secondary efficacy endpoints were short-term outcomes (overall mortality and morbidity at postoperative day 30, specific morbidity, reoperation, length of hospital stay, and readmission)., Results: In the 1-step group, the mean preoperative body mass index before SG was 40.5 kg/m 2 (27.0-69.0), while in the 2-step group, the mean preoperative body mass index was 43.5 kg/m 2 (31.5-61.7). Mean operating time was 109 minutes (50-240) in the 1-step group and 78.7 minutes (40-175) in the 2-step group (P = .22). In the 1-step group, 6 conversions to laparotomy occurred, while in the 2-step group, 2 conversions to laparotomy occurred (P = .75). One death (.2%, in the 2-step group) and 39 complications (30 in the 1-step group [11.1%] and 9 in the 2-step group [10.2%]) also occurred. The mean length of hospital stay was 6.2 days in the 1-step group and 4.1 days in the 2-step group. At 2-year follow-up, mean body mass index was 32.4 kg/m 2 in the 1-step group and 33.2 kg/m 2 in the 2-step group (P = .15), representing excess weight losses of 61.9 and 50.1 (P = .05), respectively. The rates of revisional surgery were .7% and 2.2%, respectively., Conclusions: SG after previous GB is efficient with similar outcomes depending on the 1- or 2-step approach. The 1-step approach seems to have increased weight loss compared with the 2-step approach., (Copyright © 2020 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

The sleeve gastrectomy (SG) can be performed with or without antral preservation (distance from the pylorus <50 mm). The objective of this study was to evaluate the distance between the pylorus and the end of the left vagus nerve in order to determine whether it could be used as a constant anatomical landmark to start gastric transection. This was a prospective, nonrandomized study of 120 patients undergoing SG from January to October 2018. The distance measurement between pylorus and vagus nerve was performed at the beginning of the SG. The primary endpoint was the distance between the beginning of the pylorus and the end of the second branch of the vagus nerve on the upper edge of the antrum. The secondary endpoints was the correlation factors between the preoperative data and the position of the end of the vagus nerve. A total of 120 patients, with a mean body mass index of 42.2 kg/m 2 , underwent primary SG. The mean distance between pylorus and the end of the vagus nerve was 50.4 mm (35-64) on the upper part of the antrum. When considering the inferior part of the antrum, the minimum distance was 50 mm. No correlations were found between preoperative data and distance measurements. The vagus nerve can be considered as a constant and reliable anatomical landmark for performing SG with antral preservation. However, no correlation was found between the preoperative data and the location of the end of the vagus nerve. Clin. Anat. 33:562-566, 2020. © 2019 Wiley Periodicals, Inc., (© 2019 Wiley Periodicals, Inc.)

Background: Empirical antibiotherapy (EA) should target all bacteria in post-operative peritonitis (PP). Nevertheless, recent studies failed to prove a link between adequacy of EA and prognosis of PP. We sought to confirm this loss of association between adequate EA and prognosis and to analyze the evolution of patients' characteristics and antimicrobial strategies. Methods: This is was retrospective study. Patients with a positive fungal culture were excluded. The cohort was divided into two time periods. Data of survivors and non-survivors were compared within each time period. Differences between the two periods were assessed. A multivariable analysis searched for parameters associated with a higher hospital mortality rate. Results: Two hundred fifty-one patients were included, with 92 patients in the first period (P1) and 152 patients in the second period (P2). Inadequate EA was associated with a worse outcome only in P1. The multivariable analysis in the whole cohort showed that inadequate EA was associated with a higher mortality rate. When the differences noticed between the two periods were entered in the model (presence of resistant gram-positive cocci and EA comprising glycopeptides), inadequate EA was no longer associated with worse outcome. In P1, the most severe patients had more resistant bacteria, hence, had a higher rate of inadequate EA. This artifact disappeared in P2, during which broader antibiotherapies with triple EA were more often prescribed for the most severe patients. Conclusion: This study showed that the link between inadequate EA and outcome of patients with PP was at least partly artifactual in older studies.

Background: Few series are available on the results of repeat sleeve gastrectomy (re-SG) and Roux-en-Y gastric bypass (RYGB) performed to manage the failure of primary sleeve gastrectomy (SG). The objective of this study was to compare the short- and medium-term outcomes of re-SG and RYGB after SG., Material & Methods: Between January 2010 and December 2017, patients undergoing re-SG (n = 61) and RYGB (n = 83) for failure of primary SG were included in this study. Revisional surgery was proposed for patients with insufficient excess weight loss (EWL ≤ 50%) or weight regain. The primary endpoint was the comparison of weight loss in the re-SG group and the RYGB group at the 1-year follow-up. The secondary endpoints were overall mortality and morbidity, specific morbidity, length of stay, weight loss, and correction of comorbidities., Results: The mean interval between SG and re-SG was 41.5 vs. 43.2 months between SG and RYGB (p = 0.32). The mean operative time was 103 min (re-SG group) vs. 129.4 min (RYGB group). One death (1.7%; re-SG group) and 25 complications (17.4%; 9 in the re-SG group, 16 in the RYGB group) were observed. At the 1 year, mean body mass index was 31.6 in the re-SG group and 32.5 in the RYGB group (p = 0.61) and excess weight loss was 69.5 vs. 61.2, respectively (p = 0.05)., Conclusion: Re-SG and RYGB as revisional surgery for SG are feasible with acceptable outcomes and similar results on weight loss on the first postoperative year.

Background: Obesity is a risk factor for chronic kidney disease (CKD) and a relative contraindication for renal transplantation. Bariatric surgery (BS) is an option to address this issue but we hypothesize that severe CKD is associated with a loss of efficacy of BS which could justify recommending it at an earlier stage of the CKD., Methods: A retrospective study (n = 101 patients) to test primarily for differences in weight loss at 6 and 12 months according to estimated glomerular filtration rate categories (eGFR < 30 including patients on dialysis, 30-60, 60-90, and ≥ 90 ml/min/1.73 m 2 ) was performed with multivariate analysis adjusted for sex, age, BMI, surgical procedure, and diabetes. We used a second method to confirm our hypothesis comparing weight loss in patients with stage 4-5 CKD (eGFR < 30 ml/min/1.73 m 2 , n = 17), and matched controls with eGFR ≥ 90 ml/min/1.73 m 2 ., Results: In the first comparison, the multivariate analysis showed a significant positive association between eGFR and weight loss. However, after exclusion of the subgroup of patients with eGFR < 30 ml/min/1.73 m 2 , the difference between groups was no more significant. In addition, percent total weight loss (%TWL) was significantly lower in patients with severe CKD compared to controls: - 15% vs - 23% at 6 months (p < 0.01); - 17% vs - 27% at 12 months (p < 0.01). The percent excess weight loss at 1 year reached 47% in patients with stage 4-5 CKD and 68% in controls subjects (p < 0.01). Surgery was a success at 12 months (weight loss > 50% of excess weight) in 38% of advanced CKD and 88% of controls (p < 0.01)., Conclusion: The efficacy of BS was reduced in patients with advanced CKD. These results support early BS in patients with early-to-moderate CKD.

Background: Among the population of morbidly obese people, super-super-obese (SSO) individuals (body mass index >60 kg/m 2 ) present a treatment challenge for bariatric surgeons., Objectives: To compare the long-term outcomes between laparoscopic sleeve gastrectomy (SG) and laparoscopic Roux-en-Y gastric bypass (RYGB) and to evaluate the efficacy of SG as a stand-alone bariatric procedure for SSO patients., Setting: University hospital, Paris, France., Methods: We retrospectively reviewed the data outcomes of 210 SSO patients who underwent SG or RYGB between January 2000 and December 2011. The 6-year follow-up data were analyzed and compared., Results: Follow-up data at 6 years were collected for 57.1% and 52.1% of patients in the SG group and RYGB groups, respectively. Both procedures were effective at promoting weight loss. Most weight loss was achieved at 24 months with both procedures. The average percent excess weight loss and change in body mass index of SG versus RYGB showed no significant differences at the 4-year follow-up. Except for sleep apnea, RYGB showed slightly better resolution of the evaluated co-morbidities. The composite endpoint of major short-term adverse events (<30 d) occurred in 11.7% of patients with RYGB and 6.4% of those with SG (P = .02). Postoperative complications were seen in 26% of RYGB patients and 16.1% of SG patients., Conclusions: SG as a primary procedure for SSO patients remains effective even though RYGB achieves better midterm outcomes. SG can be proposed as the primary-option p+rocedure. Further investigations are needed to identify the ideal procedure for patients with symptoms of gastroesophageal reflux disease., (Copyright © 2018 American Society for Bariatric Surgery. Published by Elsevier Inc. All rights reserved.)

Introduction: Proximal gastric leak is one of the most common complications after laparoscopic sleeve gastrectomy (LSG). Endoscopy is the gold standard treatment for acute staple-line leaks. Surgery is the most effective treatment modality in case of chronic fistula., Material and Methods: A 55-year- old man presented an acute leak after LSG. The leak was treated with metal stent deployment with temporary closure. After 6 months, he presented leak recurrence with general sepsis, perigastric-infected collection, and gastro-jejunal fistula., Results: Endoscopic internal drainage (EID) was performed; however, due to fistula persistence, a surgical procedure was proposed. The patient refused revisional surgery; therefore, endoscopic salvage procedure was decided. A fully covered metal stent was deployed in order to bypass the perigastric collection creating an endoscopic gastro-jejunal anastomosis., Conclusion: Revisional surgery is the gold standard treatment for chronic fistula after SG. Endoscopic treatment with SEMS deployment may be a sound option in selected cases especially after failure of other endoscopic techniques or refusal of revisional surgery.

Introduction: Laparoscopic sleeve gastrectomy (LSG) modifies gastrointestinal substances that control hunger and satiation via the brain-gut axis. A potential mechanism implicated in weight loss is the shift in food preferences. Our aim was to assess changes in taste preferences and their relationship to weight loss., Methods: This is a prospective longitudinal observational study in 100 consecutive LSG patients. Questionnaire with photographs of tastes was administered before surgery, at postoperative (PO) day 6 and PO month 6. Participants asked to rate each item in terms of desire to consume on a 5-point Likert scale., Results: Preoperative demographics are as follows: 77 women/23 men, mean age 40.8 ± 12 years, and mean BMI 42.46 ± 6.7 kg/m 2 . Mean 6-month PO % total body weight loss (%TBWL): 24 ± 6.2%. Preferences for bitter, salty, umami, fatty, sour, spicy, and sweet decreased significantly from baseline to PO day 6 (p < 0.001) and to PO month 6 (p < 0.002). Preferences of water (4.22) did not change significantly; red wine (1.8) and cigarettes (1.86) decreased significantly at PO day-6, but returned to baseline range at PO month 6. The highest changes of preferences in 6 months were observed for fatty (delta = 1.58) and sweet (delta = 0.95), (p < 0.002). Preference for salty at 6 months negatively correlated with %TBWL (p = 0.01)., Conclusion: LSG seems to be associated with a rapid and sustained decrease in preferences for all core tastes, detectable already at PO day 6. Preferences for sweet and fatty food undergo the highest decline, whereas preferences of water, red wine, and cigarette remain unchanged. The decrease in salty preference seems to correlate with 6-month %TBWL. Further studies are needed on the long-term impact of taste changes after LSG.

Background: We evaluated the diagnostic accuracy of first interpretations of computed tomographic (CT) images and blind interpretation using predefined CT signs in patients with previous Roux-en-Y gastric bypass (RYGBP) and acute abdominal pain., Methods: We performed a retrospective chart review of patients with RYGBP who underwent surgical exploration from January 2009 to December 2014 for acute abdominal pain in our university institution, excluding patients without CT scan and comparing initial CT imaging interpretation with surgical findings. Two blinded radiologist specialists in bariatric imaging evaluated the CT images for seven previously reported CT signs. We then calculated the sensitivity and specificity of these signs and Cohen's kappa inter-observer agreement for diagnosing internal hernia., Results: Sixty-four patients had a recorded CT scan. The original CT interpretation showed that 26/64 (40%) patients had an accurate diagnosis. Cohen's kappa coefficient for concordance between surgical exploration and first interpretation was 0.26. The image review showed an accurate diagnosis was obtained in 51/64 patients (79.6%) and 48/64 (75%) patients for the first and second reader, respectively (Cohen's kappa coefficient = 0.67; 95% confidence interval = 0.52-0.76). The most prevalent sign indicating internal hernia was whirling of the mesentery (sensitivity = 82-91%; specificity = 79-93.1%)., Conclusions: CT is an important diagnostic tool for skilled readers for managing acute abdominal pain in patients with previous RYGBP. Experience in the abdominal and bariatric imaging and the use of predetermined CT image signs provided a high degree of accuracy and confidence. A low threshold for surgical exploration remains the gold standard of appropriate treatment.