Sindelfingen-böblingen, Germany

Ketogenic Diet Prior to Bariatric Surgery

According to the World Health Organization, obesity rates have nearly tripled since 1975, resulting in the mortality of four million individuals each year. Obesity contributes to a reduced quality of life and is a significant risk factor for multiple chronic diseases such as type 2 diabetes mellitus, cardiovascular disease, osteoarthritis and certain types of cancer . Bariatric surgery is regarded the most effective treatment for extreme obesity because it achieves significant long-term weight loss and improves or even eliminates obesity-related complications. Based on the American Society for Metabolic and Bariatric surgery, approximately 230.000 bariatric procedures are performed annually, and those procedures predominantly included sleeve gastrectomy and Roux-en-Y gastric bypass (RYGB) procedures. Bariatric surgery can be challenging because of an increased thickness of the abdominal wall, the presence of intra-abdominal obesity and hepatomegaly. These anatomical changes are associated with more anaesthetic and surgical manoeuvres during the procedure. Losing weight prior to the procedure is frequently advised because it may help to overcome technical challenges. It may furthermore improve short-term outcomes like surgical time, blood loss, hospital stay and postoperative complications, as well as long-term outcomes like weight loss. In the preoperative phase, weight loss can be realised by multiple dietary regimens, including low-calorie diets (LCD) (800-1500 kcal/day) and very low-calorie diets (VLCD) (<800 kcal/day). In Máxima Medical Center and a few other hospitals performing bariatric surgery in the Netherlands, the VLCD is the standard diet of choice, which begins two weeks prior to surgery. Systematic reviews reported, as result of these diets, a reduction in liver size (5-20% with a VLCD; 12-27% with a LCD), intrahepatic fat (43% with a VLCD; 40-51% with a LCD) and body weight (2.8-14.8kg with a VLCD; 5.4-23.6kg with a LCD). These diets varied in duration, from two weeks to four months. One of the primary drawbacks of these diets is the loss of metabolically active fat free mass (FFM) and lean body mass (LBM), which are crucial for whole-body protein metabolism, in addition to fat mass (FM). In contrast to FFM, LBM contains bone mass, connective tissue, internal organs and essential fat stored in these tissues. It has been hypothesised that LBM will contain 3 to 5% more fat than FFM. A significant loss of FFM may negatively affect the resting metabolic rate (RMR), slow the rate of weight loss and predispose weight regain in the long-term. A significant loss of FFM, in continuing presence of an excessive FM, may furthermore contribute to sarcopenic obesity. A second important downfall is that some patients may not tolerate a (V)LCD regime due to side-effects leading to poor compliance and subsequently poor weight loss outcomes. For clinical trials, the reported attrition rate for a (V)LCD regime is around 20%, raising concerns about the study validity. Very low-calorie ketogenic diets (VLCKD) have been proposed as a new regimen for achieving weight- and liver volume loss in patients undergoing bariatric surgery. A VLCKD is characterized by a very low carbohydrate content (<50 g/daily), a low-fat content (15-30 g fat/daily) and a high amount of proteins (1-1.5 g protein/kg ideal body weight). The beneficial effect of VLCKDs compared to (V)LCDs is the aimed preservation of FFM and RMR, while still reducing FM. In addition, the compliance of patients might be improved by VLCKDs, possibly due to the anorexigenic effect and hunger reduction of ketone bodies. Only a few small studies addressed the role of VLCKDs prior to bariatric surgery, and the data including FFM and FM is actually scarce. A retrospective cohort study found that a three-week lasting VLCKD resulted in more weight loss (5.8kg vs. 4.8kg) compared to a VLCD. In addition, two prospective cohort studies showed as result of a VLCKD, FFM was reduced by 7.6 kg (10.0%) and 0.7kg (1.1%) , whereas FM was reduced by 10.5kg (17.9%) and 5kg (8.8%). What is important to note is that these studies lack a control group, randomisation and are subjected to limitations in FFM and FM measurement due to the use of single-frequency bioelectrical impedance analysis (BIA). Therefore, a well-designed randomised controlled trial is necessary to establish the efficacy of a VLCKD.

Circulating Tumor DNA Based Adjuvant Chemotherapy in Stage II Colon Cancer Patients: the MEDOCC-CrEATE Trial

ASIA-Mesh: a Pilot Study for Diagnostics and Treatment on ASIA Syndrome Caused by Polypropylene Mesh Implantation

Worldwide there is a lot of commotion about the effects and complications of various implants. In analogy to patients with silicone breast implants, some patients report various systemic complaints following inguinal polypropylene (PP) mesh implantation, suggesting 'Autoinflammatory/Autoimmunity Syndrome Induced by Adjuvants' (ASIA; Shoenfeld's syndrome) or some other suspected systemic auto-immune/inflammatory response. Although an evidence-based and causal relationship is lacking, patients report serious complaints. Therefore, the investigators recently started seeing these patients at the outpatient clinic and developed a diagnostic workup, including an elaborate anamnesis, conventional immunologic analyses and mesh allergy testing (MAT). Further, in case the implant is removed as part of the treatment due to a persistent wish of the patient, the PP explant will be histologically examined to find additional cues for an auto-immune/inflammatory response (and thus ASIA). So far, evidence on the optimal diagnostic workup for patients with suspected ASIA syndrome is lacking completely.

Intrapartum Non-invasive Electrophysiological Monitoring

Continuous Non-invasive Electrophysiological Monitoring in High Risk Pregnancies

Pregnant women in need for maternal and/or fetal monitoring are hospitalized at the obstetric high care (OHC) of Máxima Medical Center (MMC). They are monitored for up to three times a day with conventional cardiotocography (CTG). In the meantime they reside at the OHC, but the status of the fetus and uterine activity (UA) is not monitored. Nemo Healthcare developed a wireless abdominal electrode patch for measuring fetal heart rate (FHR) and UA: The Nemo Fetal Monitoring System (NFMS). Previous research on non-invasive electrophysiological CTG (eCTG) has yielded promising results in monitoring FHR and UA both during pregnancy and labor. With the use of eCTG technology, safe continuous 24/7 monitoring is possible, which is not possible with conventional cardiotocography. The investigators hypothesize that by introducing continuous antepartum eCTG monitoring perinatal and maternal outcomes will improve. The investigators aim to include 1911 pregnant women ≥18 years old with a singleton pregnancy between 23+0 and 32+0 weeks of gestation requiring hospitalization on the OHC for maternal or fetal surveillance (including 1400 historical controls). Additional objectives: The collected NFMS and demographic data will be used to develop and verify a mathematical model for the prediction of time until (preterm) birth, which may be used in clinical practice to reduce unnecessary OHC admissions and facilitate a better timing of interventions. Furthermore, data collected in this study (NFMS, accelerometric, annotated ultrasound) will be used for the development and verification of a mathematical model for the automated detection of fetal movements in NFMS data. This latter model might provide new opportunities in non-invasive monitoring of fetal health.

Prospective RegIstration Of the peRformance of the IoTa ADNEX Model in Dutch gYnaecological Practice

Rationale: Correct pre-operative classification of ovarian tumors is critical for optimal treatment of both women with benign and malignant ovarian tumors. The International Ovarian Tumor Analysis (IOTA) consortium developed several risk-assessment strategies, including the Assessment of Different NEoplasias in the adneXa (ADNEX) model. This is a polytomous model that estimates the risk of malignancy in women with an ovarian tumor and can help differentiate benign from malignant ovarian tumors. Recent validation studies have shown superior diagnostic accuracy of the ADNEX model compared with previously developed risk-assessment strategies. However, the diagnostic accuracy of this model in daily clinical practice is still unknown. Furthermore, expertise is necessary to use this model before the results are reliable. With the recently published Dutch guideline on risk-assessment strategies of ovarian tumors, in which it is advised to use the ADNEX model, clinical data on diagnostic performance of the ADNEX model in daily Dutch gynaecological practice are necessary. Lower sensitivity and/or specificity of the model will have significant influence on the referral practice in The Netherlands. Objective: To determine the diagnostic accuracy of the IOTA ADNEX model in the discrimination between benign and malignant ovarian tumors in daily gynaecological practice in The Netherlands. Study design: Multicentre prospective cohort study. Hospitals from three oncologic networks in the Netherlands will participate in this trial. Ultrasound data will be prospectively recorded in a database for a duration of five years by means of an electronic case report form (eCRF). With these data, the diagnostic accuracy of the IOTA ADNEX model will be calculated. Study population: All women ≥ 18 years with an ovarian tumor for which ultrasound assessment in accordance with the IOTA definitions has been performed and the ADNEX model has been applied. Women with a tumor that meets the IOTA criteria of a benign 'easy descriptor' will be excluded. Data collection: All patients eligible for this study will be asked for informed consent and clinical data will be collected through eCRFs. Data will be collected in a cloud-based database by the treating physician. Main study parameters/endpoints: The sensitivity, specificity and area under the curve of the IOTA ADNEX model. Secondary analysis: Secondary endpoints include the influence of practice variation (eg type of center, volume per center, prevalence of malignancy, availability of consultation time specifically aimed at performing ultrasounds according to IOTA criteria) and the experience of the ultrasound performer on the diagnostic accuracy of the IOTA ADNEX model.

Optimal Postoperative Chest Tube and Pain Management in Patients Surgically Treated for Primary Spontaneous Pneumothorax (Pneumotrial)

High-Risk prostatE Cancer radiatiOn Versus surgERy

Detailed description: Robot assisted radical prostatectomy (RARP) and external beam radiotherapy (EBRT) combined with Androgen Deprivation Therapy (ADT) are widely used treatment modalities for high-risk non-metastatic prostate cancer (HR-PCa). Both treatments are associated with adverse effects and can have a great impact on health-related quality of life (HRQoL). To date there is no consensus on which of both is the optimal treatment for men with HR-PCa, as it is unclear which treatment is superior in terms of HRQoL, cost-effectiveness, progression-free survival (PFS) and distant metastases-free survival (DMFS). This is reflected in substantial variation between individual hospitals in the utilization of both treatment options that is not explained by patient- and tumor characteristics or patient preferences. In the RECOVER study we aim to address this knowledge gap. The insights gained can be used to tailor recommendations in (national) guidelines and in shared decision-making tools. This allows healthcare professionals to better inform their patients and allows patients to make well-informed choices.

Sodium Channel Mutations in Patient With the Anterior Cutaneous Nerve Entrapment Syndrome (ACNES)

Cerclage for the Reduction of Extreme Preterm Birth in Twin Pregnancies With a Short Cervix or Dilatation

Rationale: In the Netherlands, 250 women with a twin pregnancy deliver at < 28 weeks per year, resulting in 157 perinatal deaths. A vaginal cerclage could be an effective surgical method to reduce cervical insufficiency and with that preterm birth, but the evidence regarding its effectiveness on extreme preterm birth and (long term) neonatal outcome is lacking. Objective: To assess the effectiveness of a cerclage in women with a twin pregnancy with a midpregnancy short cervix or cervical dilatation compared to standard treatment (no cerclage) in the prevention of extreme preterm birth < 28 weeks of gestational age. Nature and extent of the burden and risks associated with participation, benefit and group relatedness: A vaginal cerclage is a minor and safe surgical procedure commonly performed in singleton pregnancies with a short cervix and a previous preterm birth in all the participating centers, thus there is experience in the participating hospitals. The results of this study will show whether a vaginal cerclage reduces extreme preterm birth in women with twin pregnancy and a short cervix, and its accompanying perinatal complications. If proven effective, the implementation of this intervention will have a huge impact on the lifelong health of these children and their families.