Discussion of EMA Draft Guideline on Quality and Equivalence of Topical Products Based on Comparison of Approved Mometasone Furoate Drugs.

Introduction: Today, the approval for a generic topical product includes the presentation of therapeutic equivalence to the originator based on clinical trials. To facilitate this procedure, in 2018 the European Medicines Agency (EMA) published a draft guideline on quality and equivalence of topical products, which includes request parameters regarding the quality of the newly developed generic product and test protocols for the implementation of equivalence tests regarding efficacy.

Methods: To date, no data are available on the quality and evidence of the proposed test conditions.

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.

Is mesh pore size in polypropylene meshes associated with the outcome in Lichtenstein inguinal hernia repair: a registry-based analysis of 22,141 patients.

Introduction: Experimental data show that large-pored meshes reduce foreign body reaction, inflammation and scar bridging and thus improve mesh integration. However, clinical data on the effect of mesh porosity on the outcome of hernioplasty are limited. This study investigated the relation of pore size in polypropylene meshes to the outcome of Lichtenstein inguinal hernioplasty using data from the Herniamed registry.

STRONGHOLD first-year results of biomechanically calculated abdominal wall repair: a propensity score matching.

Purpose: Every year around 70,000 people in Germany suffer from an abdominal incisional hernia that requires surgical treatment. Five years after reconstruction about 25% reoccur. Incisional hernias are usually closed with mesh using various reconstruction techniques, summarized here as standard reconstruction (SR).

Drain versus no drain in elective open incisional hernia operations: a registry-based analysis with 39,523 patients.

Purpose: Elective open incisional hernia operations are a frequently performed and complex procedure. Prophylactic drainage is widely practised to prevent local complications, but nevertheless the benefit of surgical drain placement remains a controversially discussed subject. Objective of this analysis was to evaluate the current status of patient care in clinical routine and outcome in this regard.

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

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.

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.

One-stage versus two-stage Roux-Y gastric bypass as redo surgery of failed adjustable gastric banding.

Introduction: The study focussed on whether a one-stage Roux-Y gastric bypass (OS-RYGB) or a two-stage RYGB (TS-RYGB) has a significant advantage in terms of perioperative risk in patients after failed adjustable gastric banding (AGB).

Methods: Data collection included patients who underwent OS-RYGB or TS-RYGB after AGB between 2005 and 2019 and whose outcomes were compared with those after primary RYGB (P-RYGB). Outcome criteria were perioperative complications, comorbidities, 30-day mortality and operating time.

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.

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.

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.

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.

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

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/m.

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/m preoperatively.

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.

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). 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.

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.

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.

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

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.

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

Introduction: Haemoassist 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 Haemoassist 2.

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

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).

Comparing routine administrative data with registry data for assessing quality of hospital care in patients with inguinal hernia.

Introduction: Collecting clinical data is viewed as the gold standard for assessing health-care quality. However, considerable investment is needed if the quality of care is to be recorded over a long period of time. Accordingly, the question arises as to whether routine administrative data may be used for quality assurance purposes if certain methodological standards are followed.

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.