Randomized controlled trial of vacuum therapy for intermittent claudication

OBJECTIVE: The "gold standard" treatment of intermittent claudication (IC) is supervised exercise therapy (SET). Intermittent vacuum therapy (IVT) has recently been promoted as an additional treatment of IC. During IVT, negative pressure and atmospheric pressure are alternatingly applied to the lower extremities, possibly resulting in improved circulation. The aim of this study was to determine a potential additional effect of IVT in IC patients undergoing a standardized SET program. METHODS: IC patients were recruited from three Dutch general hospitals between December 2015 and July 2017. They received a standardized SET program but were also randomly assigned to an intervention group receiving an IVT treatment (-50 mBar negative pressure) or a control group receiving a sham treatment (-5 mBar negative pressure). IVT was provided in a dedicated clinic during 12 sessions of 30 minutes during a 6-week period. The primary outcome measure was a change in maximal treadmill walking distance. Secondary outcome measures were a change in functional treadmill walking distance, 6-minute walk test, ambulatory ability, and quality of life. RESULTS: A total of 78 patients were randomized, of whom 70 were available for intention-to-treat analysis (control, n = 34; intervention, n = 36). At 6 and 12 weeks, increases in walking distance were of equal magnitude. Median (interquartile range) change in maximal treadmill walking distance during 12 weeks was +335 (205-756) meters in control patients and +250 (77-466) meters in intervention patients (P = .109), whereas functional treadmill walking distance increased +230 (135-480) meters and +188 (83-389) meters (P = .233), respectively. Mean ± standard deviation change in the 6-minute walk test was +36 ± 48 meters and +55 ± 63 meters (P = .823), respectively. Ambulatory ability and quality of life improved equally in both groups. CONCLUSIONS: IVT does not confer any additional beneficial effects in IC patients undergoing a standardized SET program

Mesenchymal tumor organoid models recapitulate rhabdomyosarcoma subtypes

Rhabdomyosarcomas (RMS) are mesenchyme-derived tumors and the most common childhood soft tissue sarcomas. Treatment is intense, with a nevertheless poor prognosis for high-risk patients. Discovery of new therapies would benefit from additional preclinical models. Here, we describe the generation of a collection of 19 pediatric RMS tumor organoid (tumoroid) models (success rate of 41%) comprising all major subtypes. For aggressive tumors, tumoroid models can often be established within 4-8 weeks, indicating the feasibility of personalized drug screening. Molecular, genetic, and histological characterization show that the models closely resemble the original tumors, with genetic stability over extended culture periods of up to 6 months. Importantly, drug screening reflects established sensitivities and the models can be modified by CRISPR/Cas9 with TP53 knockout in an embryonal RMS model resulting in replicative stress drug sensitivity. Tumors of mesenchymal origin can therefore be used to generate organoid models, relevant for a variety of preclinical and clinical research questions

A Review of Surgical Informed Consent: Past, Present, and Future. A Quest to Help Patients Make Better Decisions

Contains fulltext : 87422.pdf (publisher's version ) (Closed access)BACKGROUND: Informed consent (IC) is a process requiring a competent doctor, adequate transfer of information, and consent of the patient. It is not just a signature on a piece of paper. Current consent processes in surgery are probably outdated and may require major changes to adjust them to modern day legislation. A literature search may provide an opportunity for enhancing the quality of the surgical IC (SIC) process. METHODS: Relevant English literature obtained from PubMed, Picarta, PsycINFO, and Google between 1993 and 2009 was reviewed. RESULTS: The body of literature with respect to SIC is slim and of moderate quality. The SIC process is an underestimated part of surgery and neither surgeons nor patients sufficiently realize its importance. Surgeons are not specifically trained and lack the competence to guide patients through a legally correct SIC process. Computerized programs can support the SIC process significantly but are rarely used for this purpose. CONCLUSIONS: IC should be integrated into our surgical practice. Unfortunately, a big gap exists between the theoretical/legal best practice and the daily practice of IC. An optimally informed patient will have more realistic expectations regarding a surgical procedure and its associated risks. Well-informed patients will be more satisfied and file fewer legal claims. The use of interactive computer-based programs provides opportunities to improve the SIC process.1 juli 201

Comparing the efficacy of targeted spinal cord stimulation (SCS) of the dorsal root ganglion with conventional medical management (CMM) in patients with chronic post-surgical inguinal pain: the SMASHING trial

Abstract Background A significant number of patients who undergo a standard inguinal hernia repair or a Pfannenstiel incision develop chronic (> 3 months) post-surgical inguinal pain (PSIP) due to nerve entrapment. If medication or peripheral nerve blocks fail, surgery including neurectomies may offer relief. However, some patients do not respond to any of the currently available remedial treatment modalities. Targeted spinal cord stimulation (SCS) of the dorsal root ganglion (DRG) is a relatively new type of therapy that has a potential to significantly reduce chronic PSIP. The Axium® SCS System (Spinal Modulation Inc., NY, USA) has been shown to be safe and successful in small cohorts of PSIP patients. Aim of this study is to evaluate targeted spinal cord stimulation therapy in patients with PSIP. Methods A prospective, multicentre, randomized controlled trial with optional one-way crossover will assess the efficacy of the Axium® SCS system for the treatment of PSIP. Seventy-eight patients with intractable PSIP following open hernia repair or Pfannenstiel incision who did not respond favorably to previous pain treatment regimens including a neurectomy will be randomized to either an Axium® SCS arm or a control arm receiving only conventional medical management (CMM). Primary outcome is the difference in percentage of subjects with ≥50% pain relief after 6 months using a Numerical Pain Rating Scale (NPRS). Data are collected using a daily pain/sleep diary and a number needed to treat (NNT) analysis is performed. Various secondary outcomes will be collected. Discussion Targeted SCS stimulation of the DRG using the Axium® SCS system will possibly offer significant pain reduction in patients with PSIP who are refractory to other treatment modalities. Trial registration The study protocol is registered at the NIH Clinical Trials Registry (http://clinicaltrials.gov, ClinicalTrials.gov identifier: NCT02349659) on January 29, 2015

Factors Determining Outcome After Surgery for Chronic Groin Pain Following a Lichtenstein Hernia Repair

Some patients develop chronic groin pain after a Lichtenstein hernia repair. Previous studies have demonstrated beneficial effects of removal of entrapped inguinal nerves or a meshectomy in patients with chronic pain after open inguinal hernia mesh repair. Factors determining success following this remedial surgery are unknown. The aim of the study was to identify potential patient- or surgery-related factors predicting the surgical efficacy for inguinodynia following Lichtenstein repair.Consecutive adult patients with a history of persistent pain following Lichtenstein repair who underwent remedial surgery were analysed using univariate analysis. Significant confounders (p <0.05) were combined in a multivariate logistic regression model using a backward stepwise regression method.A total of 136 groin pain operations were available for analysis. Factors contributing to success were removal of a meshoma (OR 4.66) or a neuroma (OR 5.60) and the use of spinal anaesthesia (OR 4.38). In contrast, female gender (OR 0.30) and preoperative opioid use (OR 0.38) were significantly associated with a less favourable outcome. Using a multivariate analysis model, surgery under spinal anaesthesia (OR 4.04), preoperative use of opioids (OR 0.37), and meshoma removal (OR 5.31) greatly determined surgical outcome.Pain reduction after remedial surgery for chronic groin pain after Lichtenstein repair is more successful if surgery is performed under spinal anaesthesia compared to general anaesthesia. Removal of a meshoma must be considered as success rates are optimized following these measures. Patients using opioids preoperatively have less favourable outcomes

Incidence of abdominal pain due to the anterior cutaneous nerve entrapment syndrome in an emergency department

BACKGROUND: Patients with chronic abdominal pain occasionally suffer from the anterior cutaneous nerve entrapment syndrome (ACNES). A substantial number of patients report previous visits to an emergency department (ED) with acute pain. Aim of this study was to obtain the incidence of ACNES in patients presenting with abdominal pain in the ED of a Dutch teaching hospital. METHODS: In this observational study, data sets of all patients visiting Máxima Medical Center’s (MMC) ED in 2011–2012 were searched for key terms ‘ACNES’, ‘intercostal neuralgia’ or ‘abdominal wall pain’. Files of potential patients living within hospital’s adherence area were checked using accepted criteria indicating the presence of ACNES. Disease incidence was calculated as a ratio to the hospital’s adherence data. The ACNES MMC 2013’s incidence in patients evaluated in the surgical outpatient department was also calculated. RESULTS: During the study period, 473 ED patient files met inclusion criteria. A total of 88 patients belonging to MMC’s adherence area were diagnosed with ACNES leading to a mean 22/100.000 ACNES yearly incidence rate. About one of 50 patients with abdominal pain visiting the ED suffered from ACNES. A 35/100.000 outpatient department ACNES incidence rate was calculated in the year of 2013. Combining these two ratios, a 1:1800 ACNES incidence in the general population was obtained. CONCLUSIONS: In an ED setting of a Dutch teaching hospital, approximately 2% of patients presenting with acute abdominal pain suffered from ACNES. ED physicians should consider ACNES in abdominal pain patients with normal laboratory or imaging tests