Continuous versus interrupted abdominal wall closure after emergency midline laparotomy: CONTINT: a randomized controlled trial [NCT00544583].

BACKGROUND: High-level evidence regarding the technique of abdominal wall closure for patients undergoing emergency midline laparotomy is sparse. Therefore, we conducted a randomized controlled trial (RCT) to evaluate the efficacy and safety of two commonly applied abdominal wall closure strategies after primary emergency midline laparotomy. METHODS/DESIGN: CONTINT was a multi-center pragmatic open-label exploratory randomized controlled parallel trial. Two different abdominal wall closure strategies in patients undergoing primary midline laparotomy for an emergency surgical intervention with a suspected septic focus in the abdominal cavity were compared: the continuous, all-layer suture and the interrupted suture technique. The primary composite endpoint was burst abdomen within 30 days after surgery or incisional hernia within 12 months. As reliable data on this composite primary endpoint were not available for patients undergoing emergency surgery, it was planned to initially recruit 80 patients and conduct an interim analysis after these had completed the 12 months follow-up. RESULTS: From August 31, 2009, to June 28, 2012, 124 patients were randomized of whom 119 underwent surgery and were analyzed according to the intention-to-treat (ITT) principal. The primary composite endpoint did not differ between the continuous suture (C: 27.1%) and the interrupted suture group (I: 30.0%). None of the individual components of the primary endpoint (reoperation due to burst abdomen after 30 days (C: 13.5%, I: 15.1%) and reoperation due to incisional hernia (C: 3.0%, I:11.1%)) differed between groups. Time needed for fascial closure was longer in the interrupted suture group (C: 12.8 ± 4.5 min, I: 17.4 ± 6.1 min). BMI was associated with burst abdomen during the first 30 days with an OR of 1.17 (95% CI 1.04-1.32). CONCLUSION: This RCT showed no difference between continuous suture with slowly absorbable suture versus interrupted rapidly absorbable sutures after primary emergency midline laparotomy in rates of postoperative burst abdomen and incisional hernia after one year. However, the trial was stopped after the interim analysis due to futility as there was no chance to show superiority of one suture technique.

Comparison of Fluid Replacement with Sterofundin ISO® vs. Deltajonin® in Infants Undergoing Craniofacial Surgery-A Retrospective Study.

In recent decades, infusion solutions such as NaCl 0.9% and lactate Ringer's solution have been replaced in clinical practice. Since 2017, the national guidelines for perioperative infusion therapy in children recommend balanced isotonic solutions to maintain fluid balance. The composition of balanced infusion solutions varies with respect to their electrolyte content. Hyperchloremia may be mistaken for hypovolemia and may interfere with volume therapy in pediatric patients. Sterofundin ISO® balanced solution contains 127 mmol/L chloride and may cause hyperchloremic acidosis if administered in large volumes. OBJECTIVES: The purpose of this study was to compare the effects of Sterofundin ISO® (SF) therapy with the balanced isochloremic solution Deltajonin® (DJ) (106 mmol/L chloride) on the acid-base status in infants undergoing craniofacial surgery. METHODS: This retrospective, non-blinded study included 100 infants undergoing craniectomy due to isolated nonsyndromic sagittal craniosynostosis. The first 50 infants received Sterofundin ISO®. Due to changes in national guidelines, the infusion was changed to the isoionic Deltajonin® in an additional 50 infants in 2017. Pre- and postoperative values of chloride, pH, base excess, bicarbonate, and albumin and phosphate were determined, and the strong-ion difference, strong-ion gap, anion gap, and weak acids were calculated. RESULTS: Both groups were comparable in terms of their age, sex, underlying disease, preoperative electrolytes (except K at 3.9 ± 0.3 mmol/L (SF) vs. 4.1 ± 0.3 mmol/L (DJ) and lactate 8.7 ± 2.1 (SF) vs. 9.6 ± 2.6 mmol/L (DJ)). In the Sterofundin ISO® group, hyperchloremic metabolic acidosis was observed in 19 patients, whereas only 2 infants in the Deltajonin® group had hyperchloremic metabolic acidosis. The postoperative chloride level was 111 ± 2.7 mmol/L (SF) vs. 108 ± 2.4 mmol/L (DJ). The difference in anion gap was 12.5 ± 3.0 mmol/L (SF) vs. 14.6 ± 2.8 mmol/L (DJ), and the difference in SIDa (apparent strong-ion difference) was 30.9 mmol/L (SF) vs. 33.8 mmol/L (DJ). CONCLUSIONS: Hyperchloremic acidosis can be induced by the volume replacement with high-chloride-concentration crystalloids such as Sterofundin ISO®. This can be detected using the Stewart model.

How is hip anatomy reconstruction and inlay wear associated up to 10 years after primary THA using ceramic on highly crosslinked polyethylene bearings?

INTRODUCTION: Conventional polyethylene (PE) wear has been reported to be associated with femoral offset reconstruction and cup orientation after THA. Thus, the present study aimed (1) to determine the polyethylene wear rate of 32 mm ceramic heads with highly cross-linked polyethylene (HXLPE) inlays up to 10 years postoperatively and (2) to identify patient and surgery-related factors affecting the wear rate. METHODS: A prospective cohort study was performed, investigating 101 patients with 101 cementless THAs and ceramic (32 mm) on HXLPE bearings after 6-24 months, 2-5 years and 5-10 years postoperatively. The linear wear rate was determined using a validated software (PolyWare®, Rev 8, Draftware Inc, North Webster, IN, USA) by two reviewers, blinded to each other. A linear regression model was used to identify patient and surgery-related factors on HXLPE -wear. RESULTS: After an initial bedding-in phase of 1 year after surgery, the mean linear wear rate was 0.059 ± 0.031 mm/y at ten years (mean 7.7 years; SD 0.6 years, range 6-10), being below the osteolysis relevant threshold of 0.1 mm/year. The regression analysis demonstrated that age at surgery, BMI, cup inclination or anteversion and the UCLA score were not associated with the linear HXLPE-wear rate. Only increased femoral offset showed a significant correlation with an increased HXLPE-wear rate (correlation coefficient of 0.303; p = 0.003) with a moderate clinical effect size (Cohen's f²=0.11). CONCLUSION: In contrast to conventional PE inlays, hip arthroplasty surgeons may be less concerned about osteolysis-related wear of the HXLPE if the femoral offset is slightly increased. This allows focusing on joint anatomy reconstruction, hip stability and leg length.

Complications and revisions in anatomic and reverse short stem shoulder arthroplasty.

INTRODUCTION: One current trend in the field of shoulder arthroplasty is a design shift to shorter and metaphyseal fixed humeral stem components. The aim of this investigation is to analyze complications resulting in revision surgery after anatomic (ASA) and reverse (RSA) short stem arthroplasty. We hypothesize that complications are influenced by the type of prosthesis and indication for arthroplasty. MATERIALS AND METHODS: A total of 279 short stem shoulder prostheses were implanted by the same surgeon (162 ASA; 117 RSA), and 223 of these prostheses were implanted as primary procedures; in 54 cases, arthroplasty was performed secondary to prior open surgery. Main indications were osteoarthritis (OA) (n = 134), cuff tear arthropathy (CTA) (n = 74) and posttraumatic deformities (PTr) (n = 59). Patients were evaluated at 6 weeks (follow-up 1; FU1), 2 years (FU2) and the time span of the last follow-up defined as FU3 with a minimum FU of 2 years. Complications were categorized into early complications (within FU1), intermediate complications (within FU2) and late complications (> 2 years; FU3). RESULTS: In total, 268 prostheses (96.1%) were available for FU1; 267 prostheses (95.7%) were available for FU2 and 218 prostheses (77.8%) were available for FU3. The average time for FU3 was 53.0 months (range 24-95). A complication leading to revision occurred in 21 prostheses (7.8%), 6 (3.7%) in the ASA group and 15 (12.7%) in the RSA group (p < 0.005). The most frequent cause for revision was infection (n = 9; 42.9%). After primary implantation, 3 complications (2.2%) occurred in the ASA and 10 complications (11.0%) in the RSA group (p < 0.005). The complication rate was 2.2% in patients with OA, 13.5% in CTA and 11.9% in PTr. CONCLUSIONS: Primary reverse shoulder arthroplasty had a significantly higher rate of complications and revisions than primary and secondary anatomic shoulder arthroplasty, respectively. Therefore, indications for reverse shoulder arthroplasty should be critically questioned in each individual case.

Perioperative chemotherapy with 5-FU, leucovorin, oxaliplatin, and docetaxel (FLOT) for esophagogastric adenocarcinoma: ten years real-life experience from a surgical perspective.

PURPOSE: According to the results of FLOT4 trial, perioperative FLOT chemotherapy improved overall survival (OS) in locally advanced, resectable esophagogastric adenocarcinoma (EGA) compared to perioperative ECF/ECX. We report real-life data 10 years after introduction of perioperative FLOT at our institution. METHODS: Survival of 356 consecutive EGA patients (cT3/4 and/or cN + and/or cM1) who underwent curative surgical resection was retrospectively analysed from a prospective database. A total of 263 patients received preoperative chemotherapy according to FLOT protocol and 93 patients received an epirubicin/platinum/5FU-based regimen (EPF). Propensity score matching (PSM) according to pretretment characteristics was performed to compensate for heterogeneity between groups. RESULTS: Median OS did not differ between groups (FLOT/EPF 52.1/46.4 months, p = 0.577). After PSM, survival was non-significantly improved after FLOT compared to EPF (median OS not reached/46.4 months, p = 0.156). Perioperative morbidity and mortality did not differ between groups. Histopathologic response rate was 35% after FLOT and 26% after EPF (p = 0.169). R0 resection could be achieved more frequently after FLOT than after EPF (93%/79%, p = 0.023). CONCLUSION: Overall survival after perioperative FLOT followed by surgery is comparable to clinical trials. However, collective real-life application of FLOT failed to provide a significant survival benefit compared to EPF. In clinical reality, patient selection is triggered by age, comorbidity, tumor localization, and clinical tumor stage. Yet matched analyses support FLOT4 trial findings.

Imaging of lumpectomy surface with large field-of-view confocal laser scanning microscopy 'Histolog® scanner' for breast margin assessment in comparison with conventional specimen radiography.

PURPOSE: The Histolog® Scanner (SamanTree Medical SA, Lausanne, Switzerland) is a large field-of-view confocal laser scanning microscope designed to allow intraoperative margin assessment by the production of histological images ready for assessment in the operating room. We evaluated the feasibility and the performance of the Histolog® Scanner (HS) to correctly identify infiltrated margins in clinical practice of lumpectomy specimens. It was extrapolated if the utilization of the HS has the potential to reduce infiltrated margins and therefore reduce re-operation rates in patients undergoing breast conserving surgery (BCS) due to a primarily diagnosed breast cancer including ductal carcinoma in situ. METHODS: This is a single-center, prospective, non-interventional, diagnostic pilot study including 50 consecutive patients receiving BCS. The complete surface of the specimen was scanned using the HS intraoperatively. The surgery and the intraoperative margin assessment of the specimen was performed according to the clinical routine consisting of conventional specimen radiography as well as the clinical impression of the surgeon. Three surgeons and an experienced pathologist assessed the scans produced by the HS for cancer cells on the surface. The potential of the HS to correctly identify involved margins was compared to the results of the conventional specimen radiography alone as well as the clinical routine. The histopathological report served as the gold standard. RESULTS: 50 specimens corresponding to 300 surfaces were scanned by the HS. The mean sensitivity of the surgeons to identify involved margins with the HS was 37.5% ± 5.6%, the specificity was 75.2% ± 13.0%. The assessment of resection margins by the pathologist resulted in a sensitivity of 37.5% and a specificity of 81.0%, while the local clinical routine resulted in a sensitivity of 37.5% and a specificity of 78.2%. CONCLUSION: Acquisition of high-resolution histological images using the HS was feasible in clinical practice. Sensitivity and specificity were comparable to clinical routine. With more specific training and experience on image interpretation and acquisition, the HS may have the potential to enable more accuracy in the margin assessment of BCS specimens.

The Potential of Shear Wave Elastography to Reduce Unnecessary Biopsies in Breast Cancer Diagnosis: An International, Diagnostic, Multicenter Trial.

PURPOSE: In this prospective, multicenter trial we evaluated whether additional shear wave elastography (SWE) for patients with BI-RADS 3 or 4 lesions on breast ultrasound could further refine the assessment with B-mode breast ultrasound for breast cancer diagnosis. MATERIALS AND METHODS: We analyzed prospective, multicenter, international data from 1288 women with breast lesions rated by conventional 2 D B-mode ultrasound as BI-RADS 3 to 4c and undergoing 2D-SWE. After reclassification with SWE the proportion of undetected malignancies should be < 2 %. All patients underwent histopathologic evaluation (reference standard). RESULTS: Histopathologic evaluation showed malignancy in 368 of 1288 lesions (28.6 %). The assessment with B-mode breast ultrasound resulted in 1.39 % (6 of 431) undetected malignancies (malignant lesions in BI-RADS 3) and 53.80 % (495 of 920) unnecessary biopsies (biopsies in benign lesions). Re-classifying BI-RADS 4a patients with a SWE cutoff of 2.55 m/s resulted in 1.98 % (11 of 556) undetected malignancies and a reduction of 24.24 % (375 vs. 495) of unnecessary biopsies. CONCLUSION: A SWE value below 2.55 m/s for BI-RADS 4a lesions could be used to downstage these lesions to follow-up, and therefore reduce the number of unnecessary biopsies by 24.24 %. However, this would come at the expense of some additionally missed cancers compared to B-mode breast ultrasound (rate of undetected malignancies 1.98 %, 11 of 556, versus 1.39 %, 6 of 431) which would, however, still be in line with the ACR BI-RADS 3 definition (< 2 % of undetected malignancies).

Need for nursing care after laparoscopic and open colorectal cancer surgery: a claims data analysis in German primary care.

PURPOSE: Our study analyzes the influence of minimally invasive vs. open surgery on the postoperative need for nursing care in patients with colorectal carcinoma. Colorectal cancer is an age-related disease, and oncologic surgery is increasingly performed in elderly patients. Long-term effects of the procedural choice on patients' self-sufficiency and autonomy have not been scientifically addressed so far. METHODS: Multivariable logistic regression models based on claims data from a statutory health insurer (AOK, Baden-Württemberg, Germany) were applied to assess potential risk factors for assignment patients to a nursing care level, a German scale to categorize individual need for nursing care, at 12 and 36 months after colorectal cancer surgery. RESULTS: A total of 3996 patients were eligible to be included in the analysis. At 36 months postoperatively, 44 of 427 (10.3%) patients after minimally invasive colon cancer surgery and 231 of 1287 (17.9%) patients after open procedure were newly graded into a nursing care level (OR = 0.62, 95%CI = 0.44-0.90, p = 0.010). Thirty-four of 251 (13.5%) patients receiving minimally invasive rectal cancer surgery compared to 142 of 602 (23.6%) patients after open approach were newly assigned to a nursing care level (OR = 0.53, 95%CI = 0.34-0.81, p = 0.003). CONCLUSIONS: Laparoscopically assisted resection of colorectal cancer seems to be superior in preserving physical autonomy of elderly patients with colorectal cancer.

Imaging furcation defects with low-dose cone beam computed tomography.

Different cone beam computed tomography (CBCT) protocols have shown promising results for imaging furcation defects. This study evaluates the suitability of low-dose (LD)-CBCT for this purpose. Fifty-nine furcation defects of nine upper and 16 lower molars in six human cadavers were measured by a high-dose (HD)-CBCT protocol, a LD-CBCT protocol, and a surgical protocol. HD-CBCT and LD-CBCT measurements were made twice by two investigators and were compared with the intrasurgical measurements, which served as the reference. Furcation defect volumes generated from HD-CBCT and LD-CBCT imaging were segmented by one rater. Cohen's kappa and intraclass correlation coefficient (ICC) values were calculated to determine intra- and interrater reliability. The level of significance was set at α = 0.05. In total, 59 furcation defects of nine upper and 16 lower human molars were assessed. Comparing CBCT furcation defect measurements with surgical measurements revealed a Cohen's kappa of 0.5975 (HD-and LD-CBCT), indicating moderate agreement. All furcation defects identified by HD-CBCT were also detected by LD-CBCT by both raters, resulting in a Cohen's kappa of 1. For interrater agreement, linear furcation defect measurements showed an ICC of 0.992 for HD-CBCT and 0.987 for LD-CBCT. The intrarater agreement was 0.994(r1)/0.992(r2) for HD-CBCT and 0.987(r1)/0.991(r2) for LD-CBCT. The intermodality agreement was 0.988(r1)/0.991(r2). Paired t-test showed no significant differences between HD-CBCT and LD-CBCT measurements. LD-CBCT is a precise and reliable method for detecting and measuring furcation defects in mandibular and maxillary molars in this experimental setting. It has the potential to improve treatment planning and treatment monitoring with a far lower radiation dose than conventional HD-CBCT.

How to Measure Adherence to a Mediterranean Diet in Dental Studies: Is a Short Adherence Screener Enough? A Comparative Analysis.

This study aimed to evaluate the Mediterranean Diet Adherence Screener (MEDAS) in a study investigating the anti-inflammatory effect of a 6-week Mediterranean diet intervention on periodontal parameters. Data from a randomized clinical trial were analyzed for correlations between the MEDAS score and oral inflammatory parameters (bleeding on probing (BOP), gingival index (GI), and periodontal inflamed surface area (PISA)) and select nutrient intakes estimated by a food frequency questionnaire (FFQ) and a 24-h dietary recall (24dr). A mixed model, calculations of Spearman ρ, Lin's Concordance Coefficient (CC), and Mann-Whitney U test were used for the statistical analyses. The MEDAS score was significantly negatively correlated with periodontal inflammation (BOP: CoE −0.391, p < 0.001; GI −0.407, p < 0.001; PISA −0.348, p = 0.001) and positively correlated with poly unsaturated fatty acids/total fat, vitamin C, and fiber intake estimates obtained from the FFQ and 24dr (ρ 0.38­0.77). The FFQ and 24dr produced heterogeneously comparable intake results for most nutrients (CC 0­0.79, Spearman ρ 0.16­0.65). Within the limitations of this study, the MEDAS was able to indicate nutritional habits associated with different levels of periodontal inflammation. Accordingly, the MEDAS can be a sufficient and useful diet screener in dental studies. Due to its correlation with oral inflammatory parameters, the MEDAS might also be useful in dental practice.

[Developing a competence center for obesity and metabolic surgery-Experiences from two different clinics]. / Der Weg zum Kompetenzzentrum für Adipositas und metabolische Chirurgie ­ Erfahrungen aus 2 verschiedenen Kliniken.

BACKGROUND: Due to the high incidence of obesity and the effectiveness of obesity (metabolic) surgery, the number of metabolic operations and the formation of certified obesity centers continue to increase. The aim of this study was to compare the experiences of two hospitals during establishing a certified obesity center in Heidelberg/Salem (HD/Salem) and in Baden-Baden (Bad). MATERIAL AND METHODS: The operation numbers, surgical procedures, the need for revision and the length of hospital stay were analyzed from August 2012 to June 2015 in HD/Salem and from May 2017 to December 2021 in Bad. In addition, a structured survey of patients took place to find out the preferred discharge date. The statistical evaluation was carried out with T-tests and χ2-tests for binary data. RESULTS: This analysis comprised 387 patients (181 patients Bad). There were 258 female patients (131 Bad). The mean age of all patients was 44.6 years (44.0 years Bad), the mean body mass index was 47.5 kg/m2 (47.0 kg/m2 Bad). In 12 of 206 patients (5.8%) from HD/Salem and 8 of 181 patients (4.4%) from Bad a revision was necessary. The average length of hospital stay decreased in HD/Salem from 6.5 days to 4.4 days (p < 0.05) and from 3.7 days to 3.4 days in Bad. Late revisions were necessary in HD/Salem in 4 of 206 patients (2.2%) and in Bad in 8 out of 181 patients (4.4%). The needed number of yearly operations required for certification was achieved for the first time in HD/Salem after 7 years and in Bad after 4 years. CONCLUSION: Building an obesity center at a different location from scratch to certification can be initiated and carried out by one experienced surgeon without loss of treatment quality regarding morbidity and mortality. From the start, the team should be familiar with early and late complications of metabolic surgery.

SmartPAN: In vitro and in vivo proof-of-safety assessments for an intra-operative predictive indicator of postoperative pancreatic fistula.

Pancreatic surgery is complicated by untreated fluid leakage, but no tenable techniques exist to detect and close leakage sites during surgery. A novel hydrogel called SmartPAN has been developed to meet this need and is here assessed for safety before trials on human patients. First, resazurin assays were used to test the cytotoxic effects of SmartPAN's active bromothymol blue (BTB) indicator and its solution of phosphate-buffered saline (PBS) on normal (HPDE: human pancreatic duct epithelial) or carcinomic (FAMPAC) human pancreatic cells. Cells incubated with BTB showed no significant reduction in cell viability below threshold safety levels. However, PBS had a mild cytotoxic effect on FAMPAC cells. Second, SmartPAN's pathological effects were evaluated in vivo by applying 4-ml SmartPAN to a porcine (Sus scrofa domesticus) model of pancreatic resection. There were no significant differences in macroscopic and microscopic pathologies between pigs treated with SmartPAN or saline. Third, measurements using HPLC-MS/MS demonstrate that BTB does not cross into the bloodstream and was eliminated from the body within 2 days of surgery. Overall, SmartPAN appears safe in the short term and ready for first-in-human trials because its components are either biocompatible or quickly neutralized by dilution and drainage.

A New Practical Decision Rule to Better Differentiate BI-RADS 3 or 4 Breast Masses on Breast Ultrasound.

OBJECTIVES: The BI-RADS classification provides a standardized way to describe ultrasound findings in breast cancer diagnostics. However, there is little information regarding which BI-RADS descriptors are most strongly associated with malignancy, to better distinguish BI-RADS 3 (follow-up imaging) and 4 (diagnostic biopsy) breast masses. METHODS: Patients were recruited as part of an international, multicenter trial (NCT02638935). The trial enrolled 1294 women (6 excluded) categorized as BI-RADS 3 or 4 upon routine B-mode ultrasound examination. Ultrasound images were evaluated by three expert physicians according to BI-RADS. All patients underwent histopathological confirmation (reference standard). We performed univariate and multivariate analyses (chi-square test, logistic regression, and Krippendorff's alpha). RESULTS: Histopathologic evaluation showed malignancy in 368 of 1288 masses (28.6%). Upon performing multivariate analysis, the following descriptors were significantly associated with malignancy (P < .05): age ≥50 years (OR 8.99), non-circumscribed indistinct (OR 4.05) and microlobulated margin (OR 2.95), nonparallel orientation (OR 2.69), and calcification (OR 2.64). A clinical decision rule informed by these results demonstrated a 97% sensitivity and missed fewer cancers compared to three physician experts (range of sensitivity 79-95%) and a previous decision rule (sensitivity 59%). Specificity was 44% versus 22-83%, respectively. The inter-reader reliability of the BI-RADS descriptors and of the final BI-RADS score was fair-moderate. CONCLUSIONS: A patient should undergo a diagnostic biopsy (BI-RADS 4) instead of follow-up imaging (BI-RADS 3) if the patient is 50 years or older or exhibits at least one of the following features: calcification, nonparallel orientation of mass, non-circumscribed margin, or posterior shadowing.

Long-term results of more than 13 years after arthroscopic repair of triangular fibrocartilage complex (TFCC) Palmer 1B tears: a comparison with short- and mid-term results.

PURPOSE: Goal of this study was the assessment of long-term outcome of arthroscopically assisted repair of Palmer 1B/Atzei 1 triangular fibrocartilage complex tears and the comparison with short- and mid-term results. METHODS: The study included nineteen patients (mean 49.2 years of age) with a mean follow-up time of 13.6 years (13.1-14.3 years). Examination parameters included disabilities of arm, shoulder, and hand (DASH) questionnaire, modified Mayo Wrist Score (MMWS), Krimmer Score, determination of range of motion in comparison to the contralateral extremity. Grip and pinch grip strength measurement and pain level assessment was performed, as well. RESULTS: The mean MMWS after at least 13.1 years was 95.8 (85-100, SD 5.6). Mean DASH Score was 10.2 (0-55.8, SD 13.6). Mean Krimmer Score was 97.2 (85-100, SD 4.8). Grip strength reached 101% of the contralateral unaffected hand. Range of motion did not differ significantly in comparison to the healthy contralateral extremity. None of the patients suffered from major complications. Fourteen of nineteen patients regarded pain level reduction as excellent. Five patients reported a relevant pain level reduction. Sixteen of nineteen patients regarded functional outcome as excellent, the other three patients reported on a pleasing improvement of the functional outcome. CONCLUSION: Arthroscopically assisted repair of Palmer 1B/Atzei 1 triangular fibrocartilage complex tears may be an efficacious and safe surgical technique for ulnar-sided TFCC tears in the long term.

Comparison of Diffusion Signal Models for Fiber Tractography in Eloquent Glioma Surgery-Determination of Accuracy Under Awake Craniotomy Conditions.

OBJECTIVE: Fiber tractography (FT) has become an important noninvasive tool to ensure maximal safe tumor resection in eloquent glioma surgery. Intraoperatively applied FT is still predominantly based on diffusion tensor imaging (DTI). However, reconstruction schemes of high angular resolution diffusion imaging data for high-resolution FT (HRFT) are gaining increasing attention. The aim of this prospective study was to compare the accuracy of sophisticated HRFT models compared with DTI-FT. METHODS: Ten patients with eloquent gliomas underwent surgery under awake craniotomy conditions. The localization of acquisition points, representing deteriorations during intraoperative electrostimulation (IOM) and neuropsychological mapping, were documented. The offsets of acquisition points to the respective fiber bundle were calculated. Probabilistic Q-ball imaging (QBI) and constrained spherical deconvolution (CSD)-FT were compared with DTI-FT for the major language-associated fiber bundles (superior longitudinal fasciculus [SLF] II-IV, inferior fronto-occipital fasciculus, and inferior longitudinal fasciculus/medial longitudinal fasciculus). RESULTS: Among 186 offset values, 46% were located closer than 10 mm to the estimated fiber bundle (CSD, 36%; DTI, 40% and QBI, 60%). Moreover, only 10 offsets were further away than 30 mm (5%). Lowest mean minimum offsets (SLF, 7.7 ± 7.9 mm; inferior fronto-occipital fasciculus, 12.7 ± 8.3 mm; inferior longitudinal fasciculus/medial longitudinal fasciculus, 17.7 ± 6.7 mm) were found for QBI, indicating a significant advantage compared with CSD or DTI (P < 0.001), respectively. No significant differences were found between CSD-FT and DTI-FT offsets (P = 0.105), albeit for the compound SLF exclusively (P < 0.001). CONCLUSIONS: Comparing HRFT techniques QBI and CSD with DTI, QBI delivered significantly better results with lowest offsets and good correlation to IOM results. Besides, QBI-FT was feasible for neurosurgical preoperative and intraoperative applications. Our findings suggest that a combined approach of QBI-FT and IOM under awake craniotomy is considerable for best preservation of neurological function in the presented setting. Overall, the implementation of selected HRFT models into neuronavigation systems seems to be a promising tool in glioma surgery.

Does conventional specimen radiography after neoadjuvant chemotherapy of breast cancer help to reduce the rate of second surgeries?

PURPOSE: This is the first study to systematically evaluate the diagnostic accuracy of intraoperative specimen radiography on margin level and its potential to reduce second surgeries in patients treated with neoadjuvant chemotherapy. METHODS: This retrospective study included 174 cases receiving breast conserving surgery (BCS) after neoadjuvant chemotherapy (NACT) of primary breast cancer. Conventional specimen radiography (CSR) was performed to assess potential margin infiltration and recommend an intraoperative re-excision of any radiologically positive margin. The histological workup of the specimen served as gold standard for the evaluation of the accuracy of CSR and the potential reduction of second surgeries by CSR-guided re-excisions. RESULTS: 1044 margins were assessed. Of 47 (4.5%) histopathological positive margins, CSR identified 9 correctly (true positive). 38 infiltrated margins were missed (false negative). This resulted in a sensitivity of 19.2%, a specificity of 89.2%, a positive predictive value (PPV) of 7.7%, and a negative predictive value (NPV) of 95.9%. The rate of secondary procedures was reduced from 23 to 16 with a number needed to treat (NNT) of CSR-guided intraoperative re-excisions of 25. In the subgroup of patients with cCR, the prevalence of positive margins was 10/510 (2.0%), PPV was 1.9%, and the NNT was 85. CONCLUSION: Positive margins after NACT are rare and CSR has only a low sensitivity to detect them. Thus, the rate of secondary surgeries cannot be significantly reduced by recommending targeted re-excisions, especially in cases with cCR. In summary, CSR after NACT is inadequate for intraoperative margin assessment but remains useful to document removal of the biopsy site clip.

The potential of combined shear wave and strain elastography to reduce unnecessary biopsies in breast cancer diagnostics - An international, multicentre trial.

BACKGROUND: Shear wave elastography (SWE) and strain elastography (SE) have shown promising potential in breast cancer diagnostics by evaluating the stiffness of a lesion. Combining these two techniques could further improve the diagnostic performance. We aimed to exploratorily define the cut-offs at which adding combined SWE and SE to B-mode breast ultrasound could help reclassify Breast Imaging Reporting and Data System (BI-RADS) 3-4 lesions to reduce the number of unnecessary breast biopsies. METHODS: We report the secondary results of a prospective, multicentre, international trial (NCT02638935). The trial enrolled 1288 women with BI-RADS 3 to 4c breast masses on conventional B-mode breast ultrasound. All patients underwent SWE and SE (index test) and histopathologic evaluation (reference standard). Reduction of unnecessary biopsies (biopsies in benign lesions) and missed malignancies after recategorising with SWE and SE were the outcome measures. RESULTS: On performing histopathologic evaluation, 368 of 1288 breast masses were malignant. Following the routine B-mode breast ultrasound assessment, 53.80% (495 of 920 patients) underwent an unnecessary biopsy. After recategorising BI-RADS 4a lesions (SWE cut-off ≥3.70 m/s, SE cut-off ≥1.0), 34.78% (320 of 920 patients) underwent an unnecessary biopsy corresponding to a 35.35% (320 versus 495) reduction of unnecessary biopsies. Malignancies in the new BI-RADS 3 cohort were missed in 1.96% (12 of 612 patients). CONCLUSION: Adding combined SWE and SE to routine B-mode breast ultrasound to recategorise BI-RADS 4a patients could help reduce the number of unnecessary biopsies in breast diagnostics by about 35% while keeping the rate of undetected malignancies below the 2% ACR BI-RADS 3 definition.

A multicenter cohort study of early complications after cranioplasty: results of the German Cranial Reconstruction Registry.

OBJECTIVE: Cranioplasty (CP) is a crucial procedure after decompressive craniectomy and has a significant impact on neurological improvement. Although CP is considered a standard neurosurgical procedure, inconsistent data on surgery-related complications after CP are available. To address this topic, the authors analyzed 502 patients in a prospective multicenter database (German Cranial Reconstruction Registry) with regard to early surgery-related complications. METHODS: Early complications within 30 days, medical history, mortality rates, and neurological outcome at discharge according to the modified Rankin Scale (mRS) were evaluated. The primary endpoint was death or surgical revision within the first 30 days after CP. Independent factors for the occurrence of complications with or without surgical revision were identified using a logistic regression model. RESULTS: Traumatic brain injury (TBI) and ischemic stroke were the most common underlying diagnoses that required CP. In 230 patients (45.8%), an autologous bone flap was utilized for CP; the most common engineered materials were titanium (80 patients [15.9%]), polyetheretherketone (57 [11.4%]), and polymethylmethacrylate (57 [11.4%]). Surgical revision was necessary in 45 patients (9.0%), and the overall mortality rate was 0.8% (4 patients). The cause of death was related to ischemia in 2 patients, diffuse intraparenchymal hemorrhage in 1 patient, and cardiac complications in 1 patient. The most frequent causes of surgical revision were epidural hematoma (40.0% of all revisions), new hydrocephalus (22.0%), and subdural hematoma (13.3%). Preoperatively increased mRS score (OR 1.46, 95% CI 1.08-1.97, p = 0.014) and American Society of Anesthesiologists Physical Status Classification System score (OR 2.89, 95% CI 1.42-5.89, p = 0.003) were independent predictors of surgical revision. Ischemic stroke, as the underlying diagnosis, was associated with a minor rate of revisions compared with TBI (OR 0.18, 95% CI 0.06-0.57, p = 0.004). CONCLUSIONS: The authors have presented class II evidence-based data on surgery-related complications after CP and have identified specific preexisting risk factors. These results may provide additional guidance for optimized treatment of these patients.

Hyperspectral imaging for perioperative monitoring of microcirculatory tissue oxygenation and tissue water content in pancreatic surgery - an observational clinical pilot study.

BACKGROUND: Hyperspectral imaging (HSI) could provide extended haemodynamic monitoring of perioperative tissue oxygenation and tissue water content to visualize effects of haemodynamic therapy and surgical trauma. The objective of this study was to assess the capacity of HSI to monitor skin microcirculation and possible relations to perioperative organ dysfunction in patients undergoing pancreatic surgery. METHODS: The hyperspectral imaging TIVITA® Tissue System was used to evaluate superficial tissue oxygenation (StO2), deeper layer tissue oxygenation (near-infrared perfusion index (NPI)), haemoglobin distribution (tissue haemoglobin index (THI)) and tissue water content (tissue water index (TWI)) in 25 patients undergoing pancreatic surgery. HSI parameters were measured before induction of anaesthesia (t1), after induction of anaesthesia (t2), postoperatively before anaesthesia emergence (t3), 6 h after emergence of anaesthesia (t4) and three times daily (08:00, 14:00, 20:00 ± 1 h) at the palm and the fingertips until the second postoperative day (t5-t10). Primary outcome was the correlation of HSI with perioperative organ dysfunction assessed with the perioperative change of SOFA score. RESULTS: Two hundred and fifty HSI measurements were performed in 25 patients. Anaesthetic induction led to a significant increase of tissue oxygenation parameters StO2 and NPI (t1-t2). StO2 and NPI decreased significantly from t2 until the end of surgery (t3). THI of the palm showed a strong correlation with haemoglobin levels preoperatively (t2: r = 0.83, p < 0.001) and 6 h postoperatively (t4: r = 0.71, p = 0.001) but not before anaesthesia emergence (t3: r = 0.35, p = 0.10). TWI of the palm and the fingertip rose significantly between pre- and postoperative measurements (t2-t3). Higher blood loss, syndecan level and duration of surgery were associated with a higher increase of TWI. The perioperative change of HSI parameters (∆t1-t3) did not correlate with the perioperative change of the SOFA score. CONCLUSION: This is the first study using HSI skin measurements to visualize tissue oxygenation and tissue water content in patients undergoing pancreatic surgery. HSI was able to measure short-term changes of tissue oxygenation during anaesthetic induction and pre- to postoperatively. TWI indicated a perioperative increase of tissue water content. Perioperative use of HSI could be a useful extension of haemodynamic monitoring to assess the microcirculatory response during haemodynamic therapy and major surgery. TRIAL REGISTRATION: German Clinical Trial Register, DRKS00017313 on 5 June 2019.

Cryostorage to What End? - Autologous Stem Cell Products in Burkitt Lymphoma, Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, and Myeloproliferative Neoplasm Patients.

INTRODUCTION: Recently, we identified a huge discrepancy between the collection practice and the actual utilization of cryopreserved peripheral blood stem cells (PBSCs) for high-dose chemotherapy (HDCT) and autologous blood stem cell transplantation (ABSCT). Specifically, patients with Burkitt lymphoma, acute leukemia, and myeloproliferative neoplasms (MPN) were frequently not referred for ABSCT after successful PBSC collection. OBJECTIVE: The aim of this study was to identify variables that are associated with the non-utilization of PBSC grafts. METHODS: We retrospectively analyzed the collection, storage, and disposal of PBSC grafts in Burkitt lymphoma (n = 18), acute lymphoblastic leukemia (ALL, n = 22), MPN (n = 18), and acute myeloid leukemia (AML, n = 71) patients. Patients who underwent autologous PBSC collection at 2 collection and transplantation centers between 2001 and 2012 were included and followed up until 2016. RESULTS: None of the Burkitt lymphoma patients were referred for ABSCT. Only in 1 (6%) patient, the graft was discarded after the patient's death. In all other patients (n = 17, 94%), the grafts were stored independently of the patient's status (death, n = 4, 22%; no follow-up, n = 6, 33%; no indication for ABSCT given, n = 7, 39%). In ALL patients, 4 (18%) patients underwent ABSCT after a median follow-up of 74 (1-182) months. In the remaining patients, PBSC grafts were either discarded (8 patients, 36%) or stored until the reference date (10 patients, 45%). Seven of 18 MPN patients (39%) underwent ABSCT. ABSCT was performed in 24 (34%) AML patients. In 20 (28%) patients who were not referred to ABSCT, an allogeneic transplantation (TPL) was performed. Fifteen (21%) patients received palliative care or deceased, and their grafts were discarded in all but 1 patient. Additional grafts were discarded in 21 (31%) patients and stored in 9 (13%) patients who underwent ABSCT or allogeneic TPL (n = 44). CONCLUSIONS: As the role and efficacy of autologous HDCT/ABSCT are not established in the analyzed entities, the indication for PBSC collection should be reanalyzed in regular intervals. Moreover, PBSC grafts from patients who have deceased, have insufficient grafts, or have already undergone an allogeneic TPL should be considered for disposal or (if applicable) for research use, to economize storage costs on a rational basis.