Gjermund Johnsen

Intra-abdominal vagal blocking (VBLOC therapy): Clinical results with a new implantable medical device

BACKGROUND A new medical device uses high-frequency electrical algorithms to create intermittent vagal blocking (VBLOC therapy). The aim is to assess the effects of vagal blocking on excess weight loss (EWL), safety, dietary intake, and vagal function. METHODS An open-label, 3-center study was conducted in obese subjects (body mass index [BMI] 35-50 kg/m(2)). Electrodes were implanted laparoscopically on both vagi near the esophagogastric junction to provide electrical block. Patients were followed for 6 months for body weight, safety, electrocardiogram, dietary intake, satiation, satiety, and plasma pancreatic polypeptide (PP) response to sham feeding. To specifically assess device effects alone, no diet or exercise programs were instituted. RESULTS Thirty-one patients (mean BMI, 41.2 +/- 1.4 kg/m(2)) received the device. Mean EWL at 4 and 12 weeks and 6 months after implant was 7.5%, 11.6%, and 14.2%, respectively (all P < .001); 25% of patients lost >25% EWL at 6 months (maximum, 36.8%). There were no deaths or device-related serious adverse events (AEs). Calorie intake decreased by >30% at 4 and 12 weeks and 6 months (all P <or= .01), with earlier satiation (P < .001) and reduced hunger (P = .005). After 12 weeks, plasma PP responses were suppressed (20 +/- 7 vs 42 +/- 19 pg/mL). Average percent EWL in patients with PP response <25 pg/mL was double that with PP response >25 pg/mL (P = .02). Three patients had serious AEs that required brief hospitalization, 1 each for lower respiratory tract, subcutaneous implant site seroma, and Clostridium difficile diarrhea. CONCLUSIONS Intermittent, intra-abdominal vagal blocking is associated with significant EWL and a desirable safety profile.

A randomized clinical trial of neoadjuvant chemotherapy versus neoadjuvant chemoradiotherapy for cancer of the oesophagus or gastro-oesophageal junction

BACKGROUND Neoadjuvant therapy improves long-term survival after oesophagectomy, treating oesophageal cancer, but the evidence to date is insufficient to determine which of the two main neoadjuvant therapy types, chemotherapy (nCT) or chemoradiotherapy (nCRT), is more beneficial. We aimed to compare the effects of nCT with those of nCRT. PATIENTS AND METHODS This multicentre trial, which was conducted in Sweden and Norway, recruited 181 patients with carcinoma of the oesophagus or the gastro-oesophageal junction who were candidates for curative-intended treatment. The primary end point was histological complete response after neoadjuvant treatment, which has been shown to be correlated with increased long-term survival. Study participants were randomized to nCT or nCRT, followed by surgery with two-field lymphadenectomy. Three cycles of platin/5-fluorouracil were administered in both arms, whereas 40 Gy of concomitant radiotherapy was added in the nCRT arm. RESULTS The trial met the primary end point, histological complete response being achieved in 28% after nCRT versus 9% after nCT (P = 0.002). Lymph-node metastases were observed in 62% in the nCT group versus 35% in the nCRT group (P = 0.001). The R0 resection rate was 87% after nCRT and 74% after nCT (P = 0.04). There was no difference in overall survival between the treatment arms. CONCLUSION The addition of radiotherapy to neoadjuvant chemotherapy results in higher histological complete response rate, higher R0 resection rate, and a lower frequency of lymph-node metastases, without significantly affecting survival. CLINICALTRIALSGOV NCT01362127 (https://clinicaltrials.gov; The full study protocol was registered in the Clinical Trials Database).

Open vs laparoscopic repair of perforated peptic ulcer

AbstractBackground: Most studies have found that the only advantage to the laparoscopic treatment of perforated peptic ulcer is a reduced need for postoperative analgesia. Therefore, we set out to assess the short-term outcome of open (OR) versus laparoscopic (LR) repair of perforated peptic ulcer. Methods: A total of 62 consecutive OR patients were compared with a concurrent cohort of 17 diagnosis-matched LR controls treated at the same hospital between 1991 and 1996. Results: The OR and LR patients were comparable for age, weight, American Society of Anesthesiologists (ASA) grade, Acute Physiology and Chronic Health Evaluation (APACHE II) score, Boey score, ulcer site, Mannheim Peritonitis Index (MPI), delay of surgery, Helicobacter pylori infection, nonsteroidal antiinflammatory drug (NSAID) intake, and previous abdominal surgery. More LR than OR patients were operated on by staff surgeons (χ2= 46.9, 1 d.f., p≪ 0.01). Mortality (OR: 12, LR: two), morbidity (OR: eight, LR: two), estimated blood loss (OR: 120 ml, LR: 95 ml), solid food intake resumption (OR: 5 days, LR 4 days), NSAID consumption (OR: 2,225 mg, LR: 1,815 mg), delayed gastric emptying (OR: two, OR: one), and hospital stay (OR: 9 days, LR: 7 days) were not significantly different for the two groups. Four LR patients (23.5%) were converted to OR due to failure to progress (n= 3) or posterior perforation (n= 1). Operating time was shorter in OR patients (65 min versus 92 min, p≪ 0.01). LR patients had reduced opioid consumption (256 mg versus 134 mg, p≪ 0.01). One LR and 16 OR patients were lost to follow-up. Median follow-up was 14 months (range, 2–55) and 18 months (range, 1–62) in OR and LR patients, respectively. There were more LR than OR patients with Visick score I (p= 0.002) and more OR than LR patients with Visick score II (p= 0.0001). Scores III and IV did not differ significantly. Conclusion: The laparoscopic repair of perforated peptic ulcer does not yield any additional benefits over the open repair.

Vagal Blocking Improves Glycemic Control and Elevated Blood Pressure in Obese Subjects with Type 2 Diabetes Mellitus

Background. An active device that downregulates abdominal vagal signalling has resulted in significant weight loss in feasibility studies. Objective. To prospectively evaluate the effect of intermittent vagal blocking (VBLOC) on weight loss, glycemic control, and blood pressure (BP) in obese subjects with DM2. Methods. Twenty-eight subjects were implanted with a VBLOC device (Maestro Rechargeable System) at 5 centers in an open-label study. Effects on weight loss, HbA1c, fasting blood glucose, and BP were evaluated at 1 week to 12 months. Results. 26 subjects (17 females/9 males, 51 ± 2 years, BMI 37 ± 1 kg/m2, mean ± SEM) completed 12 months followup. One serious adverse event (pain at implant site) was easily resolved. At 1 week and 12 months, mean excess weight loss percentages (% EWL) were 9 ± 1% and 25 ± 4% (P < 0.0001), and HbA1c declined by 0.3 ± 0.1% and 1.0 ± 0.2% (P = 0.02, baseline 7.8 ± 0.2%). In DM2 subjects with elevated BP (n = 15), mean arterial pressure reduced by 7 ± 3 mmHg and 8 ± 3 mmHg (P = 0.04, baseline 100 ± 2 mmHg) at 1 week and 12 months. All subjects MAP decreased by 3 ± 2 mmHg (baseline 95 ± 2 mmHg) at 12 months. Conclusions. VBLOC was safe in obese DM2 subjects and associated with meaningful weight loss, early and sustained improvements in HbA1c, and reductions in BP in hypertensive DM2 subjects. This trial is registered with ClinicalTrials.gov NCT00555958.

Morbidity and mortality after surgery for cancer of the oesophagus and gastro-oesophageal junction: A randomized clinical trial of neoadjuvant chemotherapy vs. neoadjuvant chemoradiation

OBJECTIVE To compare the incidence and severity of postoperative complications after oesophagectomy for carcinoma of the oesophagus and gastro-oesophageal junction (GOJ) after randomized accrual to neoadjuvant chemotherapy (nCT) or neoadjuvant chemoradiotherapy (nCRT). BACKGROUND Neoadjuvant therapy improves long-term survival after oesophagectomy. To date, evidence is insufficient to determine whether combined nCT, or nCRT alone, is the most beneficial. METHODS Patients with carcinoma of the oesophagus or GOJ, resectable with a curative intention, were enrolled in this multicenter trial conducted at seven centres in Sweden and Norway. Study participants were randomized to nCT or nCRT followed by surgery with two-field lymphadenectomy. Three cycles of cisplatin/5-fluorouracil was administered in all patients, while 40 Gy of concomitant radiotherapy was administered in the nCRT group. RESULTS Of the randomized 181 patients, 91 were assigned to nCT and 90 to nCRT. One-hundred-and-fifty-five patients, 78 nCT and 77 nCRT, underwent resection. There was no statistically significant difference between the groups in the incidence of surgical or nonsurgical complications (P-value = 0.69 and 0.13, respectively). There was no 30-day mortality, while the 90-day mortality was 3% (2/78) in the nCT group and 6% (5/77) in the nCRT group (P = 0.24). The median Clavien-Dindo complication severity grade was significantly higher in the nCRT group (P = 0.001). CONCLUSION There was no significant difference in the incidence of complications between patients randomized to nCT and nCRT. However, complications were significantly more severe after nCRT. REGISTRATION TRIAL DATABASE The trial was registered in the Clinical Trials Database (registration number NCT01362127).

Surgery without scars

In Natural Orifice Transluminal Endoscopic Surgery (NOTES), the procedures are performed through natural body openings, such as the mouth, vagina, urtehra and anus. By avoiding skin incisions, it is possible to prevent scars, hernias and wound infections. NOTES in humans should at this point in time only be performed within approved clinical studies.

Limitations of haptic feedback devices on construct validity of the LapSim ® virtual reality simulator

BackgroundSurgeons performing laparoscopy need a high degree of psychomotor skills, which can be trained and assessed on virtual reality (VR) simulators. VR simulators simulate the surgical environment and assess psychomotor skills according to predefined parameters. This study aimed to validate a proficiency-based training setup that consisted of two tasks with predefined threshold values and handles with haptic feedback on the LapSim® VR simulator. The two tasks have been found to have construct validity in previous studies using handles without haptic feedback.MethodsThe participants were divided into three groups: novices (0–50 laparoscopic procedures), intermediates (51–300 laparoscopic procedures), and experts (more than 300 procedures). It was assumed that psychomotor skills increase with experience. All participants conducted the tasks lifting and grasping and fine dissection 20 times each. Validity of the training setup was investigated by comparing the number of times each participant passed a predefined threshold level for a set of 19 parameters.ResultsConstruct validity was established for one parameter; “misses on right side” on the lifting and grasping task, whereas the other 18 parameters did not show construct validity.ConclusionThe setup employed in this study failed to establish construct validity for more than one parameter. This indicates that the simulation of haptic feedback influences the training performance on laparoscopic simulators and is an important part of validating a training setup. A haptic device should generate haptic sensations in a realistic manner, without introducing frictional forces that are not inherent to laparoscopy.

Long-term outcome of surgically and medically treated patients with gastroesophageal reflux disease: a matched-pair follow-up study.

Objective. A recent randomized study has shown that the long-term effects of continuous medical treatment of gastroesophageal reflux disease (GERD) with a proton-pump inhibitor are comparable to those of open fundoplication. We compared the long-term effects of anti-reflux surgery with those of medical care according to clinical practice. Methods. This is a questionnaire-based 3–10 years follow-up study of 373 patients with GERD operated on in two hospitals with either open or laparoscopic fundoplication, and pair-matched non-operated controls treated medically according to clinical practice. The controls were matched for hospital, age, sex, follow-up time, degree of esophagitis, presence of hiatus hernia and Barretts esophagus. The questionnaires used for symptoms and health-related quality of life (QoL) were the Gastrointestinal Symptoms Rating Scale and the Psychological General Well-Being Index, respectively. Results. Response rates were about 80%, and 179 pairs of operated patients and controls remained for analysis (102 based on laparoscopic and 77 on open fundoplication). Independently of the surgical technique, the operated patients suffered at the follow-up from significantly (p<0.001) fewer reflux symptoms than the non-operated controls, the mean scores being 1.34 and 2.51, respectively. The operated patients suffered from slightly more symptoms of indigestion (p<0.05). No consistent significant differences between the groups were found for QoL. Significant differences in QoL in favor of the operated patients were found when dealing only with the 43 pairs with no concurrent disease. Conclusion. The study shows that in our area anti-reflux surgery is more effective in relieving reflux symptoms than medical care according to clinical practice.

Erratum to: Intermittent Vagal Nerve Block for Improvements in Obesity, Cardiovascular Risk Factors, and Glycemic Control in Patients with Type 2 Diabetes Mellitus: 2-Year Results of the VBLOC DM2 Study

Background One-year results of the VBLOC DM2 study found that intermittent vagal blocking (VBLOC therapy) was safe among subjects with obesity and type 2 diabetes mellitus (T2DM) and led to significant weight loss and improvements in glycemic parameters and cardiovascular risk factors. Longer-term data are needed to determine whether the results are sustained.

Mechanistic Comparison between Gastric Bypass vs. Duodenal Switch with Sleeve Gastrectomy in Rat Models

Background Both gastric bypass (GB) and duodenal switch with sleeve gastrectomy (DS) have been widely used as bariatric surgeries, and DS appears to be superior to GB. The aim of this study was to better understand the mechanisms leading to body weight loss by comparing these two procedures in experimental models of rats. Methods Animals were subjected to GB, DS or laparotomy (controls), and monitored by an open-circuit indirect calorimeter composed of comprehensive laboratory animal monitoring system and adiabatic bomb calorimeter. Results Body weight loss was greater after DS than GB. Food intake was reduced after DS but not GB. Energy expenditure was increased after either GB or DS. Fecal energy content was increased after DS but not GB. Conclusion GB induced body weight loss by increasing energy expenditure, whereas DS induced greater body weight loss by reducing food intake, increasing energy expenditure and causing malabsorption in rat models.