Outcome variation and the role of caseload in certified colorectal cancer centers - a retrospective cohort analysis of 90 000 cases.

BACKGROUND: Studies have shown that surgical treatment of colorectal carcinomas in certified centers leads to improved outcomes. However, there were considerable fluctuations in outcome parameters. It has not yet been examined whether this variability is due to continuous differences between hospitals or variability within a hospital over time. MATERIALS AND METHODS: In this retrospective observational cohort study, administrative quality assurance data of 153 German-certified colorectal cancer centers between 2010 and 2019 were analyzed. Six outcome quality indicators (QIs) were studied: 30-day postoperative mortality (POM) rate, surgical site infection (SSI) rate, anastomotic insufficiency (AI) rate, and revision surgery (RS) rate. AI and RS were also analyzed for colon (C) and rectal cancer operations (R). Variability was analyzed by funnel plots with 95% and 99% control limits and modified Cleveland dot plots. RESULTS: In the 153 centers, 90 082 patients with colon cancer and 47 623 patients with rectal cancer were treated. Average QI scores were 2.7% POM, 6.2% SSI, 4.8% AI-C, 8.5% AI-R, 9.1% RS-C, and 9.8% RS-R. The funnel plots revealed that for every QI, about 10.1% of hospitals lay above the upper 99% and about 8.7% below the lower 99% control limit. In POM, SSI, and AI-R, a significant negative correlation with the average annual caseload was observed. CONCLUSION: The analysis showed high variability in outcome quality between and within the certified colorectal cancer centers. Only a small number of hospitals had a high performance on all six QIs, suggesting that significant quality variation exists even within the group of certified centers.

Incidence of incisional hernias and cosmetic outcome after laparoscopic single-incision cholecystectomy: a long-term follow-up cohort study of 125 patients.

Background: Studies have evaluated long-term occurrence of incisional hernia, cosmesis, and postoperative pain after single-incision laparoscopic cholecystectomy (SILC). However, the follow-up periods were rarely defined longer than 12 months. The authors performed a cohort study to evaluate hernia rate and cosmesis in a prolonged follow-up period. Methods: All patients that underwent SILC at the University Hospital Brandenburg an der Havel Hospital between December 2008 and November 2014 were evaluated in terms of postoperative complications, and a follow-up telephone interview including the existence of hernias and chronic pain was performed. Cosmesis and the overall satisfaction of the scar was measured by POSAS (Patient and Observer Scar Assessment Scale). Results: In total 125 patients underwent SILC. The single-incision approach was completed in 94.4%, an additional trocar was necessary in 3.2% (n=4) and a conversion to 4 trocar cholecystectomy was required in 2.4% (n=3). Intraoperative complications occurred in 0.8% and postoperative complication in 12.8% of all patients. Follow-up telephone interview was performed in 49.6% of 125 patients. The mean follow-up period was 138.9 months (11.6 years). Overall, in 3.6%, an incisional hernia was diagnosed. A total of 3.6% reported pain in the region of the umbilicus with a mean VAS (visual analog scale) of 2/10. The mean POSAS score was 7.8. Overall, 82.3% of this cohort rate their satisfaction of the scar with a 1/7, resembling the best possible result of the scar. Conclusion: The present study demonstrates that SILC is a safe alternative in terms of incisional hernia rate and complications with a high satisfaction of the scar even after one decade after surgery. In comparison to shorter follow-up period and multiport laparoscopic cholecystectomy, our result is comparable.

Technological advancements in surgical laparoscopy considering artificial intelligence: a survey among surgeons in Germany.

PURPOSE: The integration of artificial intelligence (AI) into surgical laparoscopy has shown promising results in recent years. This survey aims to investigate the inconveniences of current conventional laparoscopy and to evaluate the attitudes and desires of surgeons in Germany towards new AI-based laparoscopic systems. METHODS: A 12-item web-based questionnaire was distributed to 38 German university hospitals as well as to a Germany-wide voluntary hospital association (CLINOTEL) consisting of 66 hospitals between July and November 2022. RESULTS: A total of 202 questionnaires were completed. The majority of respondents (88.1%) stated that they needed one assistant during laparoscopy and rated the assistants' skillfulness as "very important" (39.6%) or "important" (49.5%). The most uncomfortable aspects of conventional laparoscopy were inappropriate camera movement (73.8%) and lens condensation (73.3%). Selected features that should be included in a new laparoscopic system were simple and intuitive maneuverability (81.2%), automatic de-fogging (80.7%), and self-cleaning of camera (77.2%). Furthermore, AI-based features were improvement of camera positioning (71.3%), visualization of anatomical landmarks (67.3%), image stabilization (66.8%), and tissue damage protection (59.4%). The reason for purchasing an AI-based system was to improve patient safety (86.1%); the reasonable price was €50.000-100.000 (34.2%), and it was expected to replace the existing assistants' workflow up to 25% (41.6%). CONCLUSION: Simple and intuitive maneuverability with improved and image-stabilized camera guidance in combination with a lens cleaning system as well as AI-based augmentation of anatomical landmarks and tissue damage protection seem to be significant requirements for the further development of laparoscopic systems.

The effect of biofeedback pelvic floor training with ACTICORE1 on urinary incontinence: a multicenter randomized clinical pilot trial.

Background: Pelvic floor training with biofeedback has been shown to significantly reduce symptoms of urinary incontinence. The present study aimed to evaluate the effectiveness of pelvic floor training with the ACTICORE1 biofeedback device, which uses a noninsertable pelvic floor sensor with a digital interface. Materials and methods: A multicenter randomized controlled clinical pilot study in Germany was conducted between October 2021 and January 2022. The intervention group was instructed to use ACTICORE1 for 6 min daily to train the pelvic floor for 12 weeks. The control group was instructed not to do any pelvic floor training. Over 18-year-old men and women with urinary incontinence and an International Consultation on Incontinence Questionnaire score (ICIQ) of ≥5 were included in the study. The primary endpoint was the ICIQ score 12 weeks after enrollment. The secondary endpoints were the ICIQ score and quality of life using the EG-5D-3L questionnaire 4, 8, and 12 weeks after patients' enrollment. Results: A total of 40 individuals with urinary incontinence were recruited for the present study (35 females, 5 males; 40% lost to follow-up). In terms of biometric data, both groups did not differ. At 4, 8, and 12 weeks, the ICIQ scores of those in the ACTICORE1 group decreased from 12.9 to 7.5. The ICIQ score in the control group decreased from 11.0 to 10.5. The intraindividual improvement of patients in the ACTICORE group was statistically significant. Conclusion: Biofeedback training with ACTICORE1 significantly reduces symptoms of urinary incontinence after 12 weeks.

Optimal timing for antimicrobial prophylaxis to reduce surgical site infections: a retrospective analysis of 531 patients.

It has been revealed that the administration of an antimicrobial prophylaxis (AP) reduces the rate of surgical site (SSI) following colorectal cancer surgery. Nevertheless, the optimal timing of this medication remains unclear. The aim of this study was to determine more precisely the optimal time for administering antibiotics and to see if this could reduce the number of possible surgical site infections. The files of individuals who underwent colorectal cancer surgery at the University Hospital Brandenburg an der Havel (Germany) between 2009 and 2017 were analyzed. Piperacillin/tazobactam, cefuroxime/metronidazole and mezlocillin/sulbactam were administered as AP regimens. Timing of AP was obtained. The primary objective was the rate of SSIs based on CDC criteria. Multivariate analysis took place to identify risk factors for SSIs. A total of 326 patients (61.4%) received an AP within 30 min, 166 (31.3%) between 30 and 60 min, 22 (4.1%) more than 1 h before surgery, and 15 (2.8%) after surgery. In 19 cases (3.6%) a SSI occurred during hospital stay. A multivariate analysis did not identify AP timing as a risk factor for the occurrence of SSIs. With significance, more surgical site occurrences (SSO) were diagnosed when cefuroxime/metronidazole was given. Our results suggest that AP with cefuroxime/metronidazole is less effective in reducing SSO compared with mezlocillin/sulbactam and tazobactam/piperacillin. We assume that the timing of this AP regimen of < 30 min or 30-60 min prior to colorectal surgery does not impact the SSI rate.

Quantification of mitochondrial cfDNA reveals new perspectives for early diagnosis of colorectal cancer.

BACKGROUND: To unravel how the integrity of nuclear and mitochondrial circulating cell-free DNA (cfDNA) contributes to its plasma quantity in colorectal cancer (CRC) patients. METHODS: CfDNA from plasma samples of 80 CRC patients stratified by tumour stage and 50 healthy individuals were extracted. Total cfDNA concentration was determined and equal template concentrations (ETC) were analyzed by quantitative real-time PCR (qPCR) resulting in small and long fragments of KRAS, Alu and MTCO3. The obtained data was also examined relative to the total cfDNA concentration (NTC) and diagnostic accuracy was estimated using receiver operating characteristics. RESULTS: Total cfDNA levels were significantly higher in CRC group compared to healthy control and increased with tumour stage. Long nuclear fragment levels were significantly lower in CRC patients in ETC but not NTC condition. The integrity indices of nuclear cfDNA decreased from controls to patients with highly malignant tumor. Mitochondrial cfDNA fragment quantities were strongly reduced in early and late stages of tumor patients and prognostic value was higher in ETC. Predictive models based on either ETC or NTC predictor set showed comparable classification performance. CONCLUSION: Increased blood cfDNA concentration in late UICC stages inversely correlate with nuclear cfDNA integrity index and suggest that necrotic degradation is not a major cause for higher total cfDNA quantity. The diagnostic and prognostic value of MTCO3 is highly significant in early stages of CRC and can be evaluated more comprehensively, using ETC for qPCR analysis. TRIAL REGISTRATION: The study was registered retrospectively on DRKS, the german register for clinical trials (DRKS00030257, 29/09/2022).

Diagnostic, Therapy and Complications in Acute Appendicitis of 19,749 Cases Based on Routine Data: A Retrospective Multicenter Observational Study.

Background: Acute appendicitis is one of the most common emergencies in general surgery. The gold standard treatment is surgery. Complications may occur during or after an appendectomy. In addition to age, clinically important factors for the outcome after appendicitis seems to be the comorbidities and the stage of the appendicitis at the time of the operation. Large observational data describing these facts are missing. Methods: In this retrospective multicenter observational study, all inpatients over the age of 17 years with a diagnosis of acute appendicitis in 47 hospitals of the Clinotel Hospital Group between 2010 and 2017 were included. Results: A total of 19,749 patients with acute appendicitis were operated on. The number of patients with more than five secondary diagnoses has increased from 8.4% (2010) to 14.5% (2017). The number of secondary diagnoses correlates with the ages of the patients and leads to a significantly longer hospital stay. Computer tomography (CT) has gained in importance in recent years in the diagnosis of acute appendicitis. A total of 19.9% of patients received a CT in 2017. Laparoscopic appendectomy increased from 88% in 2010 to 95% in 2017 (p < 0.001). The conversion rate did not change relevant in the study period (i.e., 2.3% in 2017). Appendicitis with perforation, abscess, or generalized peritonitis was observed in 24.8% of patients. Mortality was 0.6% during the observation period and was associated with age and the number of secondary diagnoses. The analysis is based on administrative data collected primarily for billing purposes, subject to the usual limitations of such data. This includes partially incomplete clinical data. Conclusions: Multimorbidity is increasingly present in patients with acute appendicitis. Mortality is still in an acceptably low range with no increase. A CT scan is necessary for a precise diagnosis in unclear clinical situations to avoid unnecessary operations and was performed more often at the end of the study than at the beginning.

Bladed and bladeless conical trocars do not differ in terms of caused fascial defect size in a Porcine Model.

INTRODUCTION: Trocar insertion during laparoscopy may lead to complications such as bleeding, bowel puncture and fascial defects with subsequent trocar site hernias. It is under discussion whether there is a difference in the extent of the trauma and thus in the size of the fascia defect between blunt and sharp trocars. But the level of evidence is low. Hence, we performed a Porcine Model. METHODS: A total of five euthanized female pigs were operated on. The average weight of the animals was 37.85 (Standard deviation SD 1.68) kg. All pigs were aged 90 ± 5 days. In alternating order five different conical 12-mm trocars (3 × bladeless, 2 × bladed) on each side 4 cm lateral of the mammary ridge were placed. One surgeon performed the insertions after conducting a pneumoperitoneum with 12 mmHg using a Verres' needle. The trocars were removed after 60 min. Subsequently, photo imaging took place. Using the GSA Image Analyser (v3.9.6) the respective abdominal wall defect size was measured. RESULTS: The mean fascial defect size was 58.3 (SD 20.2) mm2. Bladed and bladeless trocars did not significant differ in terms of caused fascial defect size [bladed, 56.6 (SD 20) mm2 vs. bladeless, 59.5 (SD 20.6) mm2, p = 0.7]. Without significance the insertion of bladeless trocars led to the largest (Kii Fios™ First entry, APPLIEDMEDICAL©, 69.3 mm2) and smallest defect size (VersaOne™ (COVIDIEN©, 54.1 mm2). CONCLUSION: Bladed and bladeless conical 12-mm trocars do not differ in terms of caused fascial defect size in the Porcine Model at hand. The occurrence of a trocar site hernia might be largely independent from trocar design.

Impact of the COVID-19 pandemic on delays in surgical procedures in Germany: a multi-center analysis of an administrative registry of 176,783 patients.

BACKGROUND: While extensive data are available on the postponement of elective surgical procedures due to the COVID-19 pandemic for Germany, data on the impact on emergency procedures is limited. METHODS: In this retrospective case-control study, anonymized case-related routine data of a Germany-wide voluntary hospital association (CLINOTEL association) of 66 hospitals was analyzed. Operation volumes, in-hospital mortality, and COVID-19 prevalence rates in digestive surgery procedure groups and selected single surgical procedures in the one-year periods before and after the outbreak of the COVID-19 pandemic were analyzed. The analysis was stratified by admitting department (direct admission or transfer to the general surgical department, i.e., primary or secondary surgical patients) and type of admission (elective/emergent). RESULTS: The total number of primary and secondary surgical patients decreased by 22.7% and 11.7%, respectively. Among primary surgical patients more pronounced reductions were observed in elective (-25.6%) than emergency cases (-18.8%). Most affected procedures were thyroidectomies (-30.2%), operations on the anus (-24.2%), and closure of abdominal hernias (-23.9%; all P's < 0.001). Declines were also observed in colorectal (-9.0%, P = 0.002), but not in rectal cancer surgery (-3.9%, n.s.). Mortality was slightly increased in primary (1.3 vs. 1.5%, P < 0.001), but not in secondary surgical cases. The one-year prevalence of COVID-19 in general surgical patients was low (0.6%), but a significant driver of mortality (OR = 9.63, P < 0.001). CONCLUSIONS: Compared to the previous year period, the number of patients in general and visceral surgery decreased by 22.7% in the first pandemic year. At the procedure level, a decrease of 14.8% was observed for elective procedures and 6.0% for emergency procedures. COVID-19 infections in general surgical patients are rare (0.6% prevalence), but associated with high mortality (21.8%). TRIAL REGISTRATION: The present study does not meet the ICMJE definition of a clinical trial and was therefore not registered.

Mortality factors in pancreatic surgery: A systematic review. How important is the hospital volume?

BACKGROUND: How the extent of confounding adjustment impact (hospital) volume-outcome relationships in published studies on pancreatic cancer surgery is unknown. METHODS: A systematic literature search was conducted for studies that investigated the relationship between volume and outcome using a risk adjustment procedure by querying the following databases: PubMed, Cochrane Central Register of Controlled Trials, Livivo, Medline and the International Clinical Trials Registry Platform (last query: 2020/09/16). Importance of risk-adjusting covariates were assessed by effect size (odds ratio, OR) and statistical significance. The impact of covariate adjustment on hospital (or surgeon) volume effects was analyzed by regression and meta-regression models. RESULTS: We identified 87 studies (75 based on administrative data) with nearly 1 million patients undergoing pancreatic surgery that included in total 71 covariates for risk adjustment. Of these, 33 (47%) had statistically significant effects on short-term mortality and 23 (32%) did not, while for 15 (21%) factors neither effect size nor statistical significance were reported. The most important covariates for short term mortality were patient-specific factors. Concerning the covariates, single comorbidities (OR: 4.6, 95% CI: 3.3 to 6.3) had the strongest impact on mortality followed by hospital volume (OR: 2.9, 95% CI: 2.5 to 3.3) and the procedure (OR: 2.2, 95% CI: 1.9 to 2.5). Among the single comorbidities, coagulopathy (OR: 4.5, 95% CI: 2.8 to 7.2) and dementia (OR: 4.2, 95% CI: 2.2 to 8.0) had the strongest influence on mortality. The regression analysis showed a significant decrease hospital volume effect with an increasing number of covariates considered (OR: 0.06, 95% CI: 0.10 to -0.03, P < 0.001), while such a relationship was not observed for surgeon volume (P = 0.35). CONCLUSIONS: This analysis demonstrated a significant inverse relationship between the extent of risk adjustment and the volume effect, suggesting the presence of unmeasured confounding and overestimation of volume effects. However, the conclusions are limited in that only the number of included covariates was considered, but not the effect size of the non-included covariates.

Outcome Quality Beyond the Mean - An Analysis of 43,231 Pancreatic Surgical Procedures Related to Hospital Volume.

OBJECTIVE: The aim of this study was to examine whether elevated in-hospital mortality rates in lower volume hospitals are only valid on average or also apply for individual hospitals. SUMMARY OF BACKGROUND DATA: Various studies demonstrated a volume-outcome relationship in pancreatic surgery with increased mortality in low volume hospitals. However, almost all studies assessed quality indicators only for groups of hospitals by averaged measures, neglecting variability of hospital performance. METHODS: The German nationwide hospital discharge data (diagnosis-related groups-statistics) was used to determine risk-adjusted in-hospital mortality for all distal pancreatectomies (DP), pancreatoduodenectomies (Whipple-proce-dure, PD), and pylorus-preserving pancreatoduodenectomies (PPD) performed between 2011 and 2015. Hospitals were stratified according to annual and 5-year total procedure volume and examined in relation to average in-hospital mortality of the highest volume quintile. RESULTS: Lowest adjusted mortality rates were observed in highest volume quintiles for each pancreatic resection procedure, with 6.2% for DP, 8.3% for PD, and 5.7% for PPD in the 5-year observation period. With these mortality rates as reference values the analysis revealed that a non-negligible proportion of hospitals performed equal or better (DP: 430/784, 54.5%; PD: 269/611, 44.0%; PPD: 255/565, 45.1%) than the hospitals of the highest volume quintile. CONCLUSIONS: High quality of care, with in-hospital mortality rates less or equal to high-volume hospitals, is also achieved in hospitals with lesser procedure volume. Therefore, mere volume seems not suitable as proximal measure for assessing individual hospital quality. instead, more sophisticated certification systems, that allow accurate quality assessment and better reflect clinical variability, should preferred to fixed minimum volume thresholds.

[Reliability of DRG Routine Data to Analyse Treatment Outcome and Complications of Thyroid Surgery. A Critical Analysis of Data of Patient Records Compared to Administrative Data]. / Zuverlässigkeit von DRG-Routinedaten zur Analyse der Behandlungsergebnisse und Komplikationen im Rahmen der Schilddrüsenchirurgie. Ein kritischer Vergleich zwischen Krankenaktendaten und administrativen Routinedaten.

INTRODUCTION: Quality assurance of the thyroid surgery has been an important part of the work of the endocrine surgeon. For most analyses, data from register files or studies have been used. Administrative data taken from routine data are increasingly used in quality assurance for evaluation. The aim of the study is to determine the reliability of routine data to analyse the treatment outcome and complications of thyroid surgery. PATIENTS AND METHODS: In a cross-sectional study, we compared records of 121 patients with thyroid surgery for one year with the data of quality assurance of clinical routine. We determined sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) of complications. RESULTS: Screening of administrative data identified 40 specific complications; 84 by patient records. Sensitivities for the detection of complications using administrative data ranged from 31.3 to 60.0%. Specificities ranged from 97.0 to 100%; PPV were 0.77 - 1.0 and NPV were 0.56 - 1.0. CONCLUSION: Quality assurance of clinical routine data of the thyroid surgery shows deficiencies in sensitivity accompanied by high specificity. It is necessary to increase the validity of administrative routine data to carry out a reliable clinic quality analysis or to prepare volume-outcome relationships in clinical health service research. The parameter of hypocalcaemia shows the most limitations due to quality assurance of clinical routine data.

Hospital volume and mortality in liver resections for colorectal metastasis using population-based administrative data.

BACKGROUND: Approximately one-quarter of patients with colorectal carcinoma develop colorectal liver metastases (CRLM). Surgical treatment with curative intent by hepatic resection is the standard medical care. While some studies with small sample sizes have investigated the relationship between hospital procedure volume and in-hospital mortality for this diagnosis, no population-based study has been conducted. The present study was aimed at closing this gap. METHODS: Based on administrative population-based hospital discharge data (Diagnosis Related Group Statistic), patients diagnosed with CRLM and treated with hepatic resection from 2011 to 2015 were identified. The hospital operation-volume effect on risk-adjusted in-hospital mortality was examined by logistic regression models. RESULTS: During the study period, 5900 patients with CRLM were treated with hepatic resection, of whom 189 (3.2%) died before hospital discharge. Hospitals of different operation-volume quartiles did not differ in terms of mortality rates. Sensitivity analysis investigating the volume-mortality relationship separately for every resection procedure showed no clear result. Procedure frequencies vary among hospitals of different volume quartiles, with low-volume hospitals performing systematically more low-risk procedures (in terms of reduced mortality rate), than high-volume hospitals. CONCLUSION: Based on almost complete German hospital discharge data, the results did not confirm unconditional volume-outcome relationship for CRLM patients.