Evaluation of the effect of sleeve gastrectomy versus Roux-en-Y gastric bypass in patients with morbid obesity: multicenter comparative study.

INTRODUCTION: Roux-en-Y gastric bypass (RYGB) and sleeve gastrectomy (SG) are the two most performed techniques in bariatric surgery. The aim of this study is to compare two surgical procedures in terms of weight loss and the development of comorbidities such as type II diabetes mellitus T2D, arterial hypertension, sleep apnea (OSAS), and gastroesophageal reflux disease (GERD). METHODS: Data from the German Bariatric Surgery Registry (GBSR) from 2005 to 2021 were used. 1,392 RYGB and 1,132 SG primary surgery patients were included. Minimum age 18 years; five-year follow-up data available. Tests were performed with a 5% significance level. RESULTS: Loss of follow-up 95.41% within five years. Five years after surgery, the RYGB showed significant advantages in terms of excess weight loss (%EWL 64.2% vs. 56.9%) and remission rates of the studied comorbidities: hypertension (54.4% vs. 47.8%), OSAS (64.5% vs. 50.1%), and GERD (86.1% vs. 66.9%). Compared to the pre-test, individuals diagnosed with insulin-dependent T2D showed significant improvements with RYGB over a five-year period (remission rate: 75% vs. 63%). In contrast, non-insulin-dependent T2D showed no significant difference between the two approaches (p = 0.125). CONCLUSION: Both surgical procedures resulted in significant weight loss and improved comorbidities. However, the improvement in comorbidities was significantly greater in patients who underwent RYGB than in those who underwent SG, suggesting that the RYGB technique is preferable. Nevertheless, RYGB requires a high degree of surgical skill. Therefore, acquiring expertise in the technical facets of the surgery is essential to achieving favorable outcomes.

Reflux disease following primary sleeve gastrectomy: risk factors and possible causes.

INTRODUCTION: One of the most severe side effects of sleeve gastrectomy (SG) is the development or aggravation of reflux disease. This study investigates the effect of SG on the development of reflux disease and the variables that may impact this development. In addition, trends in revision surgery, weight, and comorbidity are examined among patients with reflux disease and SG and those without reflux disease and SG. This study includes 3379 individuals without reflux disease who had primary SG and were followed for three years. The demographic characteristics, comorbidities, technical features, and complications of SG were analyzed. Data were collected by the German Bariatric Surgery Registry (GBSR). 860 (25.45%) Group A patients had reflux disease following SG (Group B: no reflux after SG; 74.55%). Patients with reflux disease had longer operating times (83.8 min vs. 77.5 min, p < 0.001) and longer postoperative hospital admissions (6 days vs. 5.5 days). In group A, the %EWL was substantially greater than in group B (64.1 vs. 61.1%). 42 patients were converted from SG to RYGB (4.88%), 2 had hiatoplasty, and 5 got Endostim. There is no significant variation in perioperative complications (p value > 0.05). The incidence of complete remission of sleep apnea was higher in group A than in group B (p = 0.013; 50% vs. 44.8%). Other comorbidities were not substantially different. Reflux illness after SG is still poorly understood, despite much research. Technical and preoperative variables may promote its development. However, these assumptions remain theoretical and are not confirmed by scientific data. The majority of patients may be successfully treated using non-invasive methods, although sometimes further surgery is necessary. Despite our results and the literature, this subject is intriguing for further research.

Current status of metabolic surgery in patients with type I diabetes mellitus and obesity: a nationwide multicenter study.

PURPOSE: While obesity is prevalent among patients with type I diabetes mellitus (T1DM), the effects of metabolic surgery on patients with T1DM have not been adequately investigated. The study aims to investigate the perioperative outcomes and the improvement of comorbidity 1 year following metabolic surgery amongst this patient population. METHODS: In this study, we evaluated the effects of sleeve gastrectomy (SG) and Roux-Y gastric bypass (RYGB) on patients with T1DM and insulin resistance. RESULTS: One hundred forty-nine patients (SG n = 91 and RYGB n = 58) with obesity, T1DM, and insulin resistance were analyzed. There was no significant difference in BMI reduction and %EWL 1 year after surgery between the two groups. In the SG group, BMI reduction was 6.5 kg/m2 versus 5.9 kg/m2 in the RYGB group (p=0.406). The %EWL was 68.2 ± 25.2 in the RYGB group and 64.3 ± 21.5 in SG (p=0.332). There was also no significant difference in weight loss between the two groups (14.9 ± 5.4 kg in SG vs. 14.2 ± 7 kg in RYGB; p=0.548). In all patients, insulin requirements decreased after surgery, and in 22% of patients, insulin requirements were equivalent to those of normal-weight individuals. There was a significantly higher rate of remission of reflux in RYGB patients than in SG patients (94·44% vs 29·41; p<0.001). CONCLUSION: Patients with obesity and T1DM may benefit from metabolic surgery. Both methods produce satisfactory results in this group of patients regarding daily insulin requirements and treatment of obesity-related diseases. However, the decision of which procedure should be carried out still depends on the patient's general condition and the surgeon's technical ability.

The effect of Roux-en-Y gastric bypass compared with omega-loop gastric bypass on weight loss, perioperative surgical events, and comorbidities.

BACKGROUND: In comparison to conservative therapy, bariatric surgery has shown many reasonable results. The current study investigates whether Omega-loop-gastric-bypass (OAGB) or Roux-en-Y gastric-bypass (RYGB) improves weight loss, comorbidities, and perioperative complications. METHODS: The study included 28,683 patients after RYGB and OAGB. Outcome criteria were perioperative morbidity, perioperative complications, and remission of comorbidities after one year of follow-up. RESULTS: Of them 14,253 patients had completed a one-year follow-up (13,483 patients by RYGB and 770 by OAGB). BMI reduction was a significant difference in favor of OAGB (17.5±5.6 kg/m2 for OAGB vs. 15.2±5.0 for RYGB; P<0.001). The %EWL was not significantly different between the two groups (P=0.073). There was also no significant difference in perioperative complications between the two groups (overall P>5%). Significant differences in favor of OAGB were observed in remission of insulin-dependent diabetes mellitus (IDDM) (P<0.001), and sleep apnea (P=0.002). Remission of reflux was more observed in RYGB than OAGB (P<0.001). Operating time was significantly higher in RYGB than OAGB (P<0.001). CONCLUSIONS: Compared with RYGB, OAGB showed significant advantages in many respects. In particular, remission of comorbidities was significantly better after OAGB than in patients after RYGB during the one-year follow-up period. Nevertheless, many other factors such as medical history, long-term expected goals of bariatric surgery, and preexisting comorbidities should be taken into account when determining indications between the two procedures. Further studies with longer follow-up periods should be conducted to determine the efficacy of the two methods more accurately.

Is development in bariatric surgery in Germany compatible with international standards? A review of 16 years of data.

Bariatric surgery has expanded tremendously internationally over the past decade. In recent years, bariatric surgery has experienced a significant growth in Germany. However, the question arises as to whether this development is in line with international developments or whether there is still room for improvement that could be challenged. 63,990 primary bariatric procedures recorded in the German Bariatric Surgery Registry (GBSR) were analyzed from 2005 to April 2021. The distribution of procedures according to different variants was analyzed and presented. In the last 16 years, 17 different procedures have been performed. The most common surgical procedure was sleeve gastrectomy (SG), followed by Roux-Y gastric bypass (RYGB) (42%). Adjustable gastric banding (AGB) has declined over time, from 23.5% in the first 5 years to 0.2% in recent years. In comparison, omega-loop gastric bypass has increased over the past 5 years (from 0.4% in the first 5 years to 5.9% in the last 5 years). Laparoscopic procedures have accounted for 96.4% of all bariatric surgeries in recent years. The frequency of some procedures has decreased and some bariatric procedures have lost significance. Overall, bariatric surgery in Germany has developed positively compared to the international trend. Nevertheless, there is one area that needs to be optimized: the development of robotic bariatric surgery, which crawls behind in Germany compared to other countries. To establish the technology in bariatric surgery in a timely manner, a balance must be found between cost neutrality and patient-oriented applications.

Safety and Efficacy of All Comers Treated with a Paclitaxel Coated Balloon for Below Knee Intervention.

OBJECTIVE: Data on paclitaxel coated balloons (PCBs) for below knee (BTK) angioplasty exhibited conflicting efficacy results, and previous meta-analyses suggested an increased mortality and amputation risk highlighting the need for further research. The aim of this study was to investigate safety and efficacy of PCBs for BTK interventions in a real world cohort. METHODS: Within a single centre cohort study, 552 consecutive patients were included undergoing BTK interventions with and without PCB use. Two year safety and efficacy results were compared in unadjusted and propensity score matched (PSM) analysis. RESULTS: BTK interventions were performed in 157 patients with PCB angioplasty (100% Lutonix 0.014 inch drug coated balloon; Bard Lutonix, New Hope, MN, USA) and 395 patients with plain old balloon angioplasty (POBA). The majority of interventions (> 70%) were performed for chronic limb threatening ischaemia. Mean lesion length was 20.8 ± 12.6 cm; 61.2% in the PCB and 66.7% in the POBA group were occlusions. In the PCB group, more procedures were performed for re-stenotic lesions than POBA (28.5 vs. 17.2%). In PSM analysis (128 matched pairs), the primary efficacy endpoint was freedom from clinically driven target lesion revascularisation (CD TLR), which occurred in 70.1% in the PCB and 73.1% in the POBA group at one year (p = .85; McNemar test). Survival analysis suggested lower rates of major amputations in the PCB group in unadjusted (94.4% ± 2.1 vs. 89.2% ± 1.9 in the POBA group) and PSM analyses (97.2% ± 1.6 vs. 89.3% ± 3.5) through two years, while no differences were seen for CD TLR and all cause mortality between the groups. CONCLUSION: In this all comer analysis, PCBs were found to be safe for BTK interventions with a signal towards lower amputation rates but no benefit was seen for repeat revascularisation.

One-Stage Versus Two-Stage Gastric Bypass as Redo Surgery After Failed Adjustable Gastric Banding-Observation Comparative Multicenter Study.

BACKGROUND: This study investigates the outcome of one-stage and two-stage Roux-Y gastric bypass (RYGB) as a revision procedure after failed adjustable gastric banding (AGB). MATERIAL AND METHODS: Data of patients who underwent a one-stage RYGB (OS-RYGB) or a two-stage RYGB (TS-RYGB) revision procedure after failing AGB between 2005 and 2019 were analyzed. Outcome criteria were perioperative complications, operating time, change in weight and BMI, and remission of comorbidities at 1-year follow-up. RESULTS: Data from 230 patients after OS-RYGB and 197 after TS-RYGB were analyzed. The total perioperative complication rates were not significantly different between the two groups (overall p > 5%). In the category of other complications, there was a significant difference between the two groups, with a lower rate in TS-RYGB than in OS-RYGB (p = 0.020). Wound infections occurred more frequently after TS-RYGB than after OS-RYGB (p = 0.015). Mean operating time differed significantly between the two groups (OS-RYGB (149.9 min) and TS-RYGB 191 min; p < 0.001). The change in hypertension was significantly higher in OS-RYGB (37.9 vs. 21.1%; p = 0.007). Other comorbidities showed no significant change within 1 year after surgery. Regarding the change in BMI, %TWL, and %EWL, there were no significant benefits for either group (p = 0.574, 0.762, and 0.378, respectively). CONCLUSION: Removing a failed AGB using the OS- or TS-RYGB is safe and feasible. The decision between OS- and TS-RYGB is still individual and depends on the patient's general condition, the desired goal of the procedure, and the personal competence of the surgeon. Further studies are needed to clarify long-term outcome and effect of both procedures.

The impact of sleeve gastrectomy and gastric binding on weight loss and remission on comorbidities: a national registry-based study.

BACKGROUND: In recent decades, an extensive collection of research has shown various benefits of bariatric surgery in the remission of obesity-related diseases and in weight loss in patients with obesity. This study investigated whether sleeve gastrectomy (SG) or adjustable gastric banding (AGB) has the best benefit in terms of perioperative risk, weight loss, and remission of comorbidities. METHODS: The German Bariatric Surgery Registry included 32,051 patients after SG and AGB. Outcome criteria were perioperative morbidity, perioperative complications, and remission of comorbidities after a one-year follow-up. RESULTS: Out of them 16,441 patients had completed one-year follow-up (2042 patients after AGB and 14,399 after SG). The %EWL was 40.8±23.4 for AGB and 62.4±22.6 for SG (P<0.001). BMI reduction was a significant difference in favor of SG (8.0±4.7 after AGB vs. 15.5±5.9 after SG; P<0.001). Significant differences in favor of SG were also found for remission of IDDM (P<0.001), NIDDM (P<0.001), hypertension (P<0.001), sleep apnea (P<0.001), and reflux disease (P<0.001). However, no significant difference was found between the two groups in terms of general intraoperative and general postoperative complications (P=0.809 and P=0.883, respectively). Specific postoperative complications were documented significantly more often after SG (3.4% in SG vs. 1% in AGB; P<0.001). CONCLUSIONS: Based on the results of our study, we can conclude that both SG and AGB can be safe surgical procedures. However, SG achieved more significant results in terms of remission of comorbidities. AGB is effective in patients without severe comorbidities and high BMI.

Outcome of Sleeve Gastrectomy Versus Roux-en-Y Gastric Bypass for Patients with Super Obesity (Body Mass Index > 50 kg/m2).

PURPOSE: With increasing BMI, the complexity of treating patients with obesity rises. The focus of this study is to investigate the effects of sleeve gastrectomy (SG) and Roux-en-Y gastric bypass (RYGB) on perioperative morbidity and remission of comorbidities at 3 years in patients with a BMI > 50 kg/m2. MATERIALS AND METHODS: A retrospective multicenter analysis of a prospectively maintained database was performed to enroll patients with a 3-year follow-up after SG or RYGB between 2005 and 2019 and a BMI of > 50 kg/m2 preoperatively. Patients' BMI and comorbidity status were recorded preoperatively. RESULTS: We analyzed data from 2939 patients who had at least a preoperative BMI > 50 kg/m2. A total of 1278 patients underwent RYGB surgery, and 1661 underwent SG. The distribution of sex, BMI, hypertension, reflux, and sleep apnea was significant between the two groups. Three years after surgery, the percent excess weight loss (%EWL) was 62.21% in RYGB and 55.87% in SG (p < 0.001). The change in hypertension (p < 0.001) and reflux (p < 0.001) was significantly in favor of RYGB. The change in diabetes mellitus was not significant between the two groups (p > 5%). There was a minimal difference in sleep apnea in favor of SG (p < 0.001). Mortality and overall complication rates were not significant in either group. CONCLUSION: Both procedures positively affected comorbidities, BMI, and %EWL in patients with super obesity 3 years after surgery. In some categories, RYGB was better than SG. Nevertheless, the decision between the two methods remains a matter of the surgeon's experience and the patient's general condition.

Feasibility and Short-Term Outcomes of One-Step and Two-Step Sleeve Gastrectomy as Revision Procedures for Failed Adjustable Gastric Banding Compared With Those After Primary Sleeve Gastrectomy.

Background: The practice of bariatric surgery was studied using the German Bariatric Surgery Registry (GBSR). The focus of the study was to evaluate whether revision surgery One-Step (OS) or Two-Step (TS) sleeve gastrectomy (SG) has a large benefit in terms of perioperative risk in patients after failed Adjustable Gastric Banding (AGB). Methods: The data collection includes patients who underwent One-Step SG (OS-SG) or Two-Step SG (TS-SG) as revision surgery after AGB and primary SG (P-SG) between 2005 and 2019. Outcome criteria were perioperative complications, comorbidities, 30-day mortality, and operating time. Results: The study analyzed data from 27,346 patients after P-SG, 320 after OS-SG, and 168 after TS-SG. Regarding the intraoperative complication, there was a significant difference in favor of P-SG and TS-SG compared to OS-SG (p < 0.001). The incidence of pulmonary complications was significantly higher in the OS-SG (p < 0.001). There was also a significant difference in occurrence of staple line stenosis in favor of TS-SG (p = 0.005) and the occurrence of sepsis (p = 0.008). The mean operating time was statistically longer in the TS-SG group than in the OS-SG group (p < 0.001). The 30-day mortality was not significantly different between the three groups (p = 0.727). Conclusion: In general, our study shows that converting a gastric band to a SG is safe and feasible. However, lower complications were obtained with TS-SG compared to OS-SG. Despite acceptable complication and mortality rates of both procedures, we cannot recommend any surgical method as a standard procedure. Proper patient selection is crucial to avoid possible adverse effects.

Propensity Score Matching Sleeve Gastrectomy vs. Gastric Bypass with 5 Years of Follow-Up.

PURPOSE: Beginning January 1, 2005, bariatric surgery cases were examined with the help of the quality assurance study for operative medicine. All data were registered and analyzed prospectively in cooperation with the Institute of Quality Assurance in Surgery at the Otto-von-Guericke University Magdeburg, Germany. The comparative study focuses on perioperative morbidity, complications, and remission of obesity-associated diseases after gastric bypass (RYGB) and sleeve gastrectomy (SG) at 5-year follow-up. MATERIALS AND METHODS: Data collection includes patients of full age who underwent SG or RYGB surgery between 2005 and 2017. The bougie is limited to 33-40 French for SG. The Roux-en-Y length for RYGB is set to 120-180 cm, and the biliodigestive length is set to 40-60 cm. Outcome criteria are perioperative morbidity, postoperative and intraoperative complications, and remission on comorbidities. RESULTS: Between 2005 and 2017, 64,349 patients were enrolled in German Bariatric Surgery Registry (GBSR). Primary operations that were performed were 56.328. Out of 24,146 RYGB and 24,085 SG procedures, 922 patients had a complete 5-year follow-up. These are 342 SG patients and 580 patients with RYGB. A matching was realized for n = 285 (83.3%) patient pairs based on age, BMI, gender, ASA, and comorbidities. A significant disadvantage was identified for the SG procedure regarding reflux disease compared with RYGB (36.3% vs. 8.10%; p < 0.001). There were no significant disadvantages in terms of BMI reduction [14.92 in the RYGB and 14.50 in the SG (p = 0.437)] and %EWL [60.32 in the RYGB and 58.98 in the SG (p = 0.504)]. This also applies to the remission of NIDDM, IDDM, hypertension, and sleep apnea; no significant differences were found. CONCLUSION: The results of the study show significant findings for gastroesophageal reflux. In terms of complications and obesity-associated diseases, no significant disadvantages between both treatments were found. RYGB and SG had comparable postoperative morbidity rates. The two surgical methods are legitimate bariatric procedures. However, there is a need for further evaluation to optimize patient selection in the coming years.

Propensity Score-Matching Sleeve Gastrectomy (SG) vs. Gastric Bypass (RYGB) in Patients ≥ 60 Years.

BACKGROUND: Since 1 January 2005, the practice of bariatric surgery has been examined with the help of the German Bariatric Surgery Registry (GBSR) in Germany. The focus of the study was to evaluate if sleeve gastrectomy (SG) or Roux-en-Y gastric bypass (RYGB) has the best benefit in terms of perioperative risk in patients over 60 years of age. METHODS: Data collection includes patients over the age of 60 years who underwent SG or RYGB between 2005 and 2017. The bougie is limited to 33-40 French for SG. Furthermore, the RYGB is determined to be 120-180 cm alimentary and 40-60 cm biliopancreatic length. Outcome criteria are perioperative morbidity, postoperative complications, 30-day mortality, and postoperative length of stay. RESULTS: The study analyzes data from 3561 patients beyond the age of 60 years who underwent SG (1970 patients) and RYGB (1591 patients). Mean age of the patients was 63.4 ± 3.2 in the RYGB group and 63.8 ± 3.5 in the SG group. Mean BMI was 46.4 ± 6.8 in the RYGB group and 49.1 ± 8.0 in the SG group. The average number of comorbidities was 4.5 ± 2.4 for RYGB and 4.5 ± 2.3 for SG. For the 30-day mortality, identical results were found SG vs. RYGB (0.31 vs. 0.38, p = 1.000). CONCLUSION: Based on the results of this study, it can be concluded that both SG and RYGB in patients ≥ 60 years can be considered safe surgical procedures.

Laparoscopic vs. Open Surgical Repair of Subxiphoidal Hernia Following Median Sternotomy for Coronary Bypass - Analysis of the Herniamed Registry.

Introduction: The repair of subxiphoidal incisional hernia following median sternotomy is technically demanding due to the specific anatomic situation and the lateral distracting forces in this region. Published data are available from retrospective reports with limited number of patients only. The aim of this study was to evaluate the outcome of subxiphoidal hernia repair comparing laparoscopic and open surgical approach. Materials and Methods: This analysis of Herniamed registry data of patients with subxiphoidal incisional hernia following sternotomy for coronary bypass assesses the perioperative and 1 year follow-up outcome of laparoscopic and open repair. Demographic data and perioperative outcomes were stratified by surgical approach (laparoscopic vs. open) and compared as unadjusted analyses using Chi square and Students t-tests. Results: Of 208 patients identified for the analysis 69 patients (33.2%) underwent laparoscopic and 139 (66.8%) patients had open repair. Concerning demographic data (gender, age, BMI, ASA score), risk factors and hernia size there were no significant differences between laparoscopic and open repair group. For intraoperative, postoperative and general complications as well as complication related re-operations no significant differences were seen between the groups. No significant advantage could be stated for laparoscopic repair regarding duration of operation and hospital stay. The recurrence rate at 1 year follow-up was higher in the laparoscopic group (7.2 vs. 2.2%; p = 0.072). No significant differences were reported in the 1 year follow-up evaluation of pain at rest, pain on exertion and pain requiring treatment. Conclusion: The repair of subxiphoidal incisional hernia is safe in both open and laparoscopic technique. With regard to the lower recurrence rate preference can be given to open repair.

Quality of electronic treatment records and adherence to prophylaxis in haemophilia and von Willebrand disease: Systematic assessments from an electronic diary.

INTRODUCTION: HaemoassistTM 2 is an electronic system designed for people with bleeding disorders and their physicians to record prophylactic infusions and treatment of bleeds. It aims to improve adherence by permitting reminders and accuracy of documentation by facilitating real-time reporting. AIM: To assess documentation quality and adherence to prophylactic regimens in patients with haemophilia A, haemophilia B or von Willebrand disease who are using HaemoassistTM 2. METHODS: Ten centres enrolled consecutive patients, who had been using HaemoassistTM 2 for ≥ 3 months (Cohort 1, 'quality of documentation'). Of these, patients who had a specified prophylactic regimen in HaemoassistTM 2 for ≥ 3 months were eligible for inclusion in Cohort 2 ('adherence to prophylaxis'). RESULTS: Cohort 1 comprised 796 patients (71% with severe haemophilia A; median 20.5 months of HaemoassistTM 2 use). The most common method of documentation for patients was using the mobile app; the median time between infusion and documentation was 4 hours using the app, compared with 85 hours using a web portal on a stationery device. The median total annualised number of infusions was consistent in the first and last 3 months of documentation (128; IQR: 70-184 and 120; IQR 64-176, respectively). Cohort 2 comprised 202 patients (79% severe haemophilia A; median of 13 months on prophylactic regimen in HaemoassistTM 2). The rate of adherence to prophylaxis was 83%; median deviation between planned and actual infusion time was ± 2 hours. CONCLUSION: HaemoassistTM 2 was used consistently over prolonged periods of time and allowed for precise analysis of adherence to prophylaxis.

A Novel Algorithm to Identify Predictors of Treatment Response: Tapentadol Monotherapy or Tapentadol/Pregabalin Combination Therapy in Chronic Low Back Pain?

Purpose: High dose monotherapies or drug combinations are used to achieve sufficient analgesia for the treatment of severe chronic low back pain, before invasive therapy options are considered. In order to demonstrate an alternative for an empirical treatment approach, the authors' primary aim was to present an algorithm for the objective identification of treatment predictors. Additionally, the study identified baseline-characteristics in chronic low back pain patients prior to tapentadol PR treatment, as well as scrutinized those patients, either benefitting from a medium/high dose tapentadol PR monotherapy or a combination therapy (medium dose tapentadol PR + pregabalin). Patients and Methods: The statistical approach included data of a previously published randomized, double blind, phase 3b study which compared the effectiveness and safety of tapentadol PR vs. a combination of tapentadol PR and pregabalin. In total, 46 clinical parameters were included in the statistical prediction models which were applied separately either to 50 patients who already responded well during the titration period (i.e., medium dose tapentadol PR) or to 261 patients with in the comparative treatment period [i.e., monotherapy (high dose tapentadol PR) or combination therapy (medium dose tapentadol PR/pregabalin)]. Results: The first statistical model identified three co-variables (NRS-3, PDQ, SQ) with predictive effects on patients responding well ("optimal responders") to a medium dose tapentadol PR titration. Those patients presented low baseline pain intensity scores, good sleep quality and high painDETECT scores. The second statistical model identified eight co-variables (PDQ, numbness, SF-12 MCS, SF-12 PCS, VAS, HADS-A, HADS-D, SQ) with predictive effects on patients responding to high dose tapentadol PR monotherapy vs. a combination therapy (tapentadol PR + pregabalin). The high dose tapentadol PR responders indicated high painDETECT scores, little numbness and a good mental health status. Whereas, the combination therapy (tapentadol PR + pregabalin) responders were characterized by severe sleep disturbances and little anxiety. Conclusion: The statistical analysis characterized chronic low back pain patients and identified factors contributing to a treatment response. Thus, this retrospective statistical algorithm represents an elegant method, which may contribute to future strategies toward a more individualized and improved mechanism based pain therapy.

Influencing Factors on the Outcome in Female Groin Hernia Repair: A Registry-based Multivariable Analysis of 15,601 Patients.

OBJECTIVE: Based on an analysis of data from the Herniamed Registry, this study aims to identify all factors influencing the outcome in female groin hernia repair. BACKGROUND: In a systematic review and meta-analysis of observational studies, female sex was found to be a significant risk factor for recurrence. In the guidelines, the totally extraperitoneal patch plasty (TEP) and transabdominal preperitoneal patch plasty (TAPP) laparo-endoscopic techniques are recommended for female groin hernia repair. However, even when complying with the guidelines, a less favorable outcome must be expected than in men. To date, there is no study in the literature for analysis of all factors influencing the outcome in female groin hernia repair. METHODS: In all, 15,601 female patients from the Herniamed Registry who had undergone primary unilateral groin hernia repair with the Lichtenstein, Shouldice, TEP or TAPP technique, and for whom 1-year follow-up was available, were selected between September 1, 2009 and July 1, 2017. Using multivariable analyses, influencing factors on the various outcome parameters were identified. RESULTS: In the multivariable analysis, a significantly higher risk of postoperative complications, complication-related reoperations, recurrences, and pain on exertion was found only for the Lichtenstein technique. No negative influence on the outcome was identified for the TEP, TAPP, or Shouldice techniques. Relevant risk factors for occurrence of perioperative complications, recurrences, and chronic pain were preoperative pain, existing risk factors, larger defects, a higher body mass index (BMI), higher American Society of Anesthesiologists (ASA) classification and postoperative complications. Higher age had a negative association with postoperative complications and positive association with pain rates. CONCLUSIONS: Female groin hernia repair should be performed with the TEP or TAPP laparo-endoscopic technique, or, alternatively, with the Shouldice technique, if there is no evidence of a femoral hernia. By contrast, the Lichtenstein technique has disadvantages in terms of postoperative complications, recurrences, and pain on exertion. Important risk factors for an unfavorable outcome are preoperative pain, existing risk factors, higher ASA classification, higher BMI, and postoperative complications. A higher age and larger defects have an unfavorable impact on postoperative complications and a more favorable impact on chronic pain.

Small and Laterally Placed Incisional Hernias Can be Safely Managed with an Onlay Repair.

INTRODUCTION: In meta-analyses and systematic reviews, clear advantages have been identified for the sublay versus onlay technique for treatment of incisional hernias. Nonetheless, an expert panel has noted that the onlay mesh location may be useful in certain settings. MATERIALS AND METHODS: First, unadjusted analysis of data from the Herniamed Registry was performed to compare 6797 sublay operations with 1024 onlay operations for repair of incisional hernias. Then, using propensity score matching to account for the influence of variables age, gender, ASA score, BMI, risk factors, preoperative pain, defect size, and defect localization, 1016 pairs were formed and compared with each other. RESULTS: Unadjusted analysis revealed that the onlay operation was used significantly more often for small defects, lateral defect localization, and in women. After comparing the propensity score-matched pairs, no significant difference was found between the sublay and onlay technique in the outcome criteria intra- and postoperative complications, general complications, complication-related reoperations, pain at rest, pain on exertion, chronic pain requiring treatment, and recurrence on 1-year follow-up. But that was true only for this carefully selected patient collective. CONCLUSION: In a selected patient collective with small and lateral incisional hernias and with a large proportion of women, outcomes obtained for the onlay and sublay techniques do not differ significantly.

Sleeve gastrectomy in the German Bariatric Surgery Registry from 2005 to 2016: Perioperative and 5-year results.

BACKGROUND: Recently, sleeve gastrectomy (SG) has become one of the most important procedures in bariatric surgery. Short-term results show that SG is a feasible, safe, and effective operation treating obesity and its related co-morbidities. Now, the main focus is on long-term data after SG. OBJECTIVES: The aim of this study was to analyze perioperative and long-term results after SG in the German Bariatric Surgery Registry. SETTING: National database, Germany. METHODS: Perioperative data of primary SG (n = 21525) and follow-up data for 5 years ± 6 months (n = 435, 18.3% of 2375 SG performed between 2005 and 2011) were analyzed. After a review of the literature long-term results were compared with international data. RESULTS: Mean baseline body mass index (BMI) was 51.1 kg/m2. Two hundred ninety-eight (68.5%) patients were female and 137 (31.5%) were male. Of patients, 90% had ≥1 co-morbidities. Mean operation time was 86 minutes. General postoperative complications occurred in 4.1% and special complications in 4.6% (staple-line leaks 1.6%). Mean maximum BMI loss was 18.0 ± 6.8 kg/m2 and BMI loss after 5 years was 14.3 ± 7.4 kg/m2 (P < .001). Co-morbidities, such as type 2 diabetes, hypertension, and sleep apnea, were significantly improved (P < .001). Gastroesophageal reflux was significantly impaired (P < .001). CONCLUSIONS: The current results showed that SG is a safe and effective procedure in bariatric surgery. BMI loss was significant 5 years after SG. Most co-morbidities were significantly improved, but gastroesophageal reflux has often worsened. The follow-up rate was very low, which is a persistent problem in German bariatric surgery.

Mini- or Less-open Sublay Operation (MILOS): A New Minimally Invasive Technique for the Extraperitoneal Mesh Repair of Incisional Hernias.

OBJECTIVE: Improvement of ventral hernia repair. BACKGROUND: Despite the use of mesh and other recent improvements, the currently popular techniques of ventral hernia repair have specific disadvantages and risks. METHODS: We developed the endoscopically assisted mini- or less-open sublay (MILOS) concept. The operation is performed transhernially via a small incision with light-holding laparoscopic instruments either under direct, or endoscopic visualization. An endoscopic light tube was developed to facilitate this approach (EndotorchTM Wolf Company). Each MILOS operation can be converted to standard total extraperitoneal gas endoscopy once an extraperitoneal space of at least 8 cm has been created. All MILOS operations were prospectively documented in the German Hernia registry with 1 year questionnaire follow-up. Propensity score matching of incisional hernia operations comparing the results of the MILOS operation with the laparoscopic intraperitoneal onlay mesh operation (IPOM) and open sublay repair from other German Hernia registry institutions was performed. RESULTS: Six hundred fifteen MILOS incisional hernia operations were included. Compared with laparoscopic IPOM incisional hernia operation, the MILOS repair is associated with significantly a fewer postoperative surgical complications (P < 0.001) general complications (P < 0.004), recurrences (P < 0.001), and less chronic pain (P < 0.001). Matched pair analysis with open sublay repair revealed significantly a fewer postoperative complications (P < 0.001), reoperations (P < 0.001), infections (P = 0.007), general complications (P < 0.001), recurrences (P = 0.017), and less chronic pain (P < 0.001). CONCLUSIONS: The MILOS technique allows minimally invasive transhernial repair of incisional hernias using large retromuscular/preperitoneal meshes with low morbidity. The technique combines the advantages of open sublay and the laparoscopic IPOM repair.ClinicalTrials.gov Identifier NCT03133000.