Cost-effectiveness and safety of continuous pulse oximetry for management of undiagnosed obstructive sleep apnea in bariatric surgery: a nationwide cohort study.

BACKGROUND: Undetected obstructive sleep apnea (OSA) is highly prevalent in patients undergoing bariatric surgery and increases perioperative risks. Screening for OSA using preoperative polygraphy (PG) with subsequent continuous positive airway pressure (CPAP) is costly and time-consuming. Postoperative continuous pulse oximetry (CPOX) is less invasive, and is hypothesized to be a safe and cost-effective alternative. OBJECTIVES: This nationwide multicenter prospective observational cohort study compared CPOX monitoring with OSA-screening using PG. SETTING: High-volume bariatric centers. METHODS: Patients were either postoperatively monitored using CPOX without preoperative OSA-screening, or underwent preoperative PG and CPAP treatment when OSA was diagnosed. Cohort placement was based on local hospital protocols. Cost-effectiveness was analyzed using quality adjusted life years (QALYs) and healthcare costs. Surgical outcomes were also analyzed. Propensity score matching was used in sensitivity analyses. RESULTS: A total of 1390 patients were included. QALYs were similar between groups at baseline and 1-year postoperatively. Postoperative complications, intensive care unit (ICU)-admissions and admissions, particularly OSA-related, did not differ between groups. Mean costs per patient/year in the CPOX group was €3094 versus €3680 in the PG group; mean difference €-586 (95% CI €-933-€-242). Following propensity score matching, 1090 of 1390 included patients remained, and similar findings for cost-effectiveness, complications, and ICU admissions were observed. CONCLUSION: CPOX monitoring without preoperative OSA-screening was not associated with higher complication or readmission rates compared to PG. CPOX resulted in lower costs from a healthcare perspective and can therefore be considered a cost-effective alternative to routine OSA-screening in patients undergoing bariatric surgery.

Cross-sectional E-survey on the Incidence of Pre- and Postoperative Chronic Pain in Bariatric Surgery.

BACKGROUND: To assess the prevalence, incidence, location, and behavior of chronic pre- and postoperative pain in bariatric surgery, and the use of analgesics. METHODS: A cross-sectional e-survey was conducted on 3928 post-bariatric patients and four-time points for pain assessment were evaluated: preoperative, on the ward, day 1 at home postoperatively, and present time (at the time of the e-survey). A numerical rating scale (NRS) was used to assess the level of pain (0 to 10). The general incidence of chronic pain was calculated, as also, subgroups were defined as group A (pre and postoperative chronic pain), B (preoperative pain, and no longer postoperative), and C (preoperative painless, postoperative chronic pain). Besides the pain intensity, location of pain, and the use of analgesics were investigated. RESULTS: A total of 3279 patients (83.9%) responded to the survey. Preoperative and postoperative chronic pain was found in 343 (10.5%) and 264 (8.1%) patients, respectively. In group A, chronic pain was present in 4.8% of the patients; in group B, it was present in 5.7%; and in group C in 3.3% of the patients. Furthermore, in 4.5% of patients pain was located in the abdomen, which was higher as compared to before surgery (+ 2.3%, p < 0.001). The ORs for present postoperative chronic pain were OR 1.45, 1.7, and 1.71 (p = 0.002, 0.003, 0.003) compared to respectively preoperative chronic pain, pain at the ward, and pain at day 1 after surgery. Among all participants, 4.6% consumed chronic analgesics. Of these, paracetamol was used most frequently (3.8%), followed by tramadol (1.3%) and oxycodone (0.5%). CONCLUSIONS: In this e-survey, chronic postoperative abdominal pain was prominent in patients after bariatric surgery. Of patients, 3.3% that were without preoperative chronic pain developed chronic pain after surgery. Opioid consumption in the queried population was relatively low.

The Benefits of Banded over Non-banded Roux-en-Y Gastric Bypass in Patients with Morbid Obesity: a Multi-center Study.

BACKGROUND: Roux-en-Y gastric bypass (RYGB) has proven to be an effective treatment for obesity with excellent long-term results, even though weight regain can occur. A method to improve the results of RYGB and minimize chance of weight regain is banded RYGB. Better sustained weight loss is also related to higher remission of comorbidities. The aim of this study was to evaluate the effect of banded and non-banded RYGB on long-term weight loss results and comorbidities. METHOD: A retrospective comparative data study was performed. Patients who underwent a primary RYGB between July 2013 and December 2014 and followed a 5-year follow-up program in the Dutch Obesity Clinic were included. Comorbidities were assessed during screening and follow-up. RESULTS: The study included 375 patients with mean weight and body mass index (BMI) of 128.9 (± 21.2) kg and 44.50 (± 5.72) kg/m2. Of this group, 184 patients underwent RYGB and 191 banded RYGB. During follow-up (3 months, 1-5 years) % Total Weight Loss (%TWL) was superior in the banded group (32.6% vs 27.6% at 5 years post-operative, p < 0.001). Complication rates in both groups were similar. Comorbidity improvement or remission did not significantly differ between the two groups (p = 0.14-1.00). After 5 years of follow-up, 79 patients (20.5%) were lost to follow-up. CONCLUSION: Banded RYGB does show superior weight loss compared to non-banded RYGB. No difference in effect on comorbidity improvement or remission was observed. Since complication rates are similar, while weight loss is significantly greater, we recommend performing banded RYGB over non-banded RYGB.

Single Anastomosis Duodenoileal Bypass or Roux-en-Y Gastric Bypass After Failed Sleeve Gastrectomy: Medium-Term Outcomes.

BACKGROUND: Although the sleeve gastrectomy (SG) has good short-term results, it comes with a significant number of patients requiring revisional surgery because of insufficient weight loss or functional complications. OBJECTIVE: To investigate the effectiveness of the single anastomosis duodenoileal bypass (SADI-S) versus the Roux-en-Y gastric bypass (RYGB) on health outcomes in (morbidly) obese patients who had previously undergone SG, with up to 5 years of follow-up. METHODS: Data from patients who underwent revisional SADI-S or RYGB after SG were retrospectively compared on indication of surgery, weight loss, quality of life, micronutrient deficiencies, and complications. RESULTS: From 2007 to 2017, 141 patients received revisional laparoscopic surgery after SG in three specialized Dutch bariatric hospitals (SADI-S n=63, RYGB n=78). Percentage total weight loss following revisional surgery at 1, 2, 3, 4, and 5 years was 22%, 24%, 22%, 18%, and 15% for SADI-S and 10%, 9%, 7%, 8%, and 2% for RYGB (P<.05 for 1-4 years). Patients who underwent RYGB surgery for functional complications experienced no persistent symptoms of GERD or dysphagia in 88% of cases. No statistical difference was found in longitudinal analysis of change in quality of life scores or cross-sectional analysis of complication rates and micronutrient deficiencies. CONCLUSION: Conversion of SG to SADI-S leads to significantly more total weight loss compared to RYGB surgery with no difference in quality of life scores, complication rates, or micronutrient deficiencies. When GERD in sleeve patients has to be resolved, RYGB provides adequate outcomes.

Internal Herniation Incidence After RYGB and the Predictive Ability of a CT Scan as a Diagnostic Tool.

PURPOSE: The clinical diagnosis of an internal herniation (IH) after a Roux-en-Y Gastric Bypass (RYGB) remains difficult; therefore, performing a CT scan is usually part of the diagnostic process. The goal of this study was to assess the incidence of IH in patients with open and closed MD (mesenteric defect) and to study if the ability to diagnose an IH with a CT scan is different between these groups. MATERIALS AND METHODS: IH was defined as a visible intestine through the mesenteric defect underneath the jejunojejunostomy and/or in the Petersen's space. CT scan outcomes were compared with the clinical diagnosis of an IH. Until 31 June 2013, standard care was to leave mesenteric defects (MDs) open; after this date, they were always closed. RESULTS: The incidence of IH in the primarily non-closed group was 3.9%, and in the primarily closed group, this was 1.3% (p = 0.001). In group A (non-closed MD and CT), the sensitivity of the CT scan was 80%, and specificity was 0%. In group C (closed MD and CT), the sensitivity was 64.7%, and specificity was 89.5%. In group B (non-closed, no CT), an IH was visible in 58.7% of the cases and not in 41.3%. In group D (only a re-laparoscopy), an IH was visible in 34.3% of the cases and not in 65.7%. CONCLUSIONS: Using the CT scan in suspected IH is not useful in if the MDs were not closed. If the MDs were closed, then a CT scan is predictive for the diagnosis IH.

Protocol of a multicentre, prospective cohort study that evaluates cost-effectiveness of two perioperative care strategies for potential obstructive sleep apnoea in morbidly obese patients undergoing bariatric surgery.

INTRODUCTION: Despite the high prevalence of obstructive sleep apnoea (OSA) in obese patients undergoing bariatric surgery, OSA is undiagnosed in the majority of patients and thus untreated. While untreated OSA is associated with an increased risk of preoperative and postoperative complications, no evidence-based guidelines on perioperative care for these patients are available. The aim of the POPCORN study (Post-Operative Pulse oximetry without OSA sCreening vs perioperative continuous positive airway pressure (CPAP) treatment following OSA scReeNing by polygraphy (PG)) is to evaluate which perioperative strategy is the most cost-effective for obese patients undergoing bariatric surgery without a history of OSA. METHODS AND ANALYSIS: In this multicentre observational cohort study, data from 1380 patients who will undergo bariatric surgery will be collected. Patients will receive either postoperative care with pulse oximetry monitoring and supplemental oxygen during the first postoperative night, or care that includes preoperative PG and CPAP treatment in case of moderate or severe OSA. Local protocols for perioperative care in each participating hospital will determine into which cohort a patient is placed. The primary outcome is cost-effectiveness, which will be calculated by comparing all healthcare costs with the quality-adjusted life-years (QALYs, calculated using EQ-5D questionnaires). Secondary outcomes are mortality, complications within 30 days after surgery, readmissions, reoperations, length of stay, weight loss, generic quality of life (QOL), OSA-specific QOL, OSA symptoms and CPAP adherence. Patients will receive questionnaires before surgery and 1, 3, 6 and 12 months after surgery to report QALYs and other patient-reported outcomes. ETHICS AND DISSEMINATION: Approval from the Medical Research Ethics Committees United was granted in accordance with the Dutch law for Medical Research Involving Human Subjects Act (WMO) (reference number W17.050). Results will be submitted for publication in peer-reviewed journals and presented at (inter)national conferences. TRIAL REGISTRATION NUMBER: NTR6991.

Failed Sleeve Gastrectomy: Single Anastomosis Duodenoileal Bypass or Roux-en-Y Gastric Bypass? A Multicenter Cohort Study.

BACKGROUND: Sleeve gastrectomy (SG) has become the most performed bariatric procedure to induce weight loss worldwide. Unfortunately, a significant portion of patients show insufficient weight loss or weight regain after a few years. OBJECTIVE: To investigate the effectiveness of the single anastomosis duodenoileal (SADI) bypass versus the Roux-en-Y gastric bypass (RYGB) on health outcomes in morbid obese patients who had undergone SG previously, with up to 2 years of follow-up. METHODS: From 2007 to 2017, 140 patients received revisional laparoscopic surgery after SG in four specialized Dutch bariatric hospitals. Data was analyzed retrospectively and included comparisons for indication of surgery, vitamin/mineral deficiencies, and complications; divided into short-, medium-term. To compare weight loss, linear regression and linear mixed models were used. RESULTS: Conversion of a SG to SADI was performed in 66 patients and to RYGB in 74 patients. For patients in which additional weight loss was the main indication for surgery, SADI achieved 8.7%, 12.4%, and 19.4% more total body weight loss at 6, 12, and 24 months compared to RYGB (all p < .001). When a RYGB was indicated in case of gastroesophageal reflux or dysphagia, it greatly reduced complaints almost directly after surgery. Furthermore, a similar amount of complications and nutritional deficiencies was observed for both groups. There was no intra- or post-operative mortality. CONCLUSION: Conversion into a SADI resulted in significantly more weight loss while complications rates and nutritional deficiencies were similar and may therefore be considered the recommended operation for patients in which only additional weight loss is required.

Polymicrobial bacterial pericarditis and cardiac tamponade caused by pericardial penetration of an adjustable gastric band.

We describe a case of polymicrobial bacterial pericarditis with Klebsiella pneumoniae and Proteus mirabilis, caused by pericardial penetration of the tip of the catheter of a laparoscopic adjustable gastric band (LAGB). The patient developed a cardiac tamponade, and subsequently emergency pericardiocentesis was performed. Analysis of earlier CT scans showed that the tip of the catheter had migrated through the liver and through the diaphragm into the pericardium, and was in contact with the myocardium. After stabilisation he was operated to remove the LAGB. In this case report, we describe the chain of events that led to the polymicrobial pericarditis-a complication of LAGB placement that to our knowledge has thus far never been reported. We furthermore present a detailed literature review of all published cases of polymicrobial pericarditis and its causes.

The HIPPO Trial, a Randomized Double-blind Trial Comparing Self-gripping Parietex Progrip Mesh and Sutured Parietex Mesh in Lichtenstein Hernioplasty: A Long-term Follow-up Study.

OBJECTIVE: To evaluate the effect of a self-gripping mesh (Progrip) on the incidence of chronic postoperative inguinal pain (CPIP) and recurrence rate after Lichtenstein hernioplasty. BACKGROUND: Chronic pain is the most common complication of inguinal hernioplasty. One of the causes may be the use of sutures to secure the mesh. METHODS: Adult male patients undergoing Lichtenstein hernioplasty for a primary unilateral inguinal hernia were randomized to a self-gripping polyester mesh or a sutured polyester mesh. Follow-up took place after 2 weeks, 3, 12, and 24 months. Pain and quality of life were assessed using the Verbal Rating Scale, Visual Analog Scale, and Short Form 36. CPIP was defined as moderate pain lasting at least 3 months postoperatively. RESULTS: There were 165 patients in the Progrip mesh group and 166 patients in the sutured mesh group. The incidence of CPIP was 7.3% at 3 months declining to 4.6% at 24 months and did not differ between both groups. Pain and quality of life scores were significantly improved after 2 years. Hernia recurrence rate after 24 months was 2.4% for the Progrip mesh and 1.8% for the sutured mesh (P = 0.213). The mean duration of surgery was significant shorter with the Progrip mesh (44 vs 53 minutes, P < 0.001). CONCLUSIONS: The self-gripping Progrip mesh does not reduce CPIP rates. Outcomes of the Progrip mesh are comparable to the Lichtenstein technique with the additional advantage of a reduced operation time. NCT01830452.

Twelve-year outcomes of laparoscopic adhesiolysis in patients with chronic abdominal pain: A randomized clinical trial.

BACKGROUND: Laparoscopic adhesiolysis as a therapy for chronic pain is still controversial, and long-term effects are not known; therefore, our aim was to evaluate long-term effects of laparoscopic adhesiolysis for the treatment of chronic abdominal pain believed to be related to intraperitoneal adhesions. METHODS: A total of 100 patients with abdominal pain attributed to adhesions were randomized to laparoscopic adhesiolysis or a placebo group with laparoscopy alone. Pain relief was assessed after 12-year follow-up. RESULTS: A total of 73% of patients fulfilled the long-term follow-up. Compared to the placebo group (n = 31), patients in the adhesiolysis group (n = 42) were significantly less often pain-free (8 vs 13, P = .033, relative risk [RR] = 1.3) and to have a greater intake of analgesics (26 vs 16, P = .379, RR = 1.2, 95% confidence interval 0.8-1.8). Moreover, the adhesiolysis group sought medical consultations more frequently (14 vs 6, P = .186, RR = 1.33, 95% confidence interval 0.9-1.9), and had an increased rate of additional operation (8 vs 1, P = .042, RR = 1.67, 95% confidence interval 1.208-2.318). Both groups had improved pain and quality-of-life scores. CONCLUSION: This is the first, long-term, placebo-controlled trial regarding the use of laparoscopic adhesiolysis for treating chronic abdominal pain. Laparoscopic adhesiolysis was less beneficial than laparoscopy alone in the long term. Secondly, there appeared to be a powerful, long-lasting placebo effect of laparoscopy. Because adhesiolysis is associated with an increased risk of operative complications, avoiding this treatment may result in less morbidity and health care costs.

Deep Neuromuscular Block Improves Surgical Conditions during Bariatric Surgery and Reduces Postoperative Pain: A Randomized Double Blind Controlled Trial.

BACKGROUND: It remains unknown whether the administration of a deep neuromuscular block (NMB) during bariatric surgery improves surgical conditions and patient outcome. The authors studied the effect of deep versus moderate NMB in laparoscopic bariatric surgery on surgical conditions and postoperative pain. METHODS AND RESULTS: One hundred patients scheduled to undergo elective bariatric surgery were randomized to a deep NMB (post-tetanic-count 2-3) or a moderate NMB (train-of-four 1-2). The quality of the surgical field was scored using the Leiden-Surgical Rating Scale (L-SRS), a 5-point scale ranging from 1 (extremely poor conditions) to 5 (optimal conditions). Three surgeons scored the L-SRS at 10-min intervals during surgery; postoperative pain scores were obtained in the postanesthesia-care-unit (PACU) and on the ward. Mean (95% confidence interval) L-SRS scores in moderate NMB 4.2 (4.0-4.4) versus 4.8 (4.7-4.9) in deep NMB (p < 0.001). Moderate NMB resulted in 17% of scores at L-SRS scores of 1-3, while deep NMB resulted in 100% scores at the high end of the L-SRS (4-5). Deep NMB led to improved pain scores in the PACU (4.6 (4.2-4.9) versus 3.9 (3.6-4.4), p = 0.03) and reduced shoulder pain on the ward (1.8 (1.5-2.1) versus 1.3 (1.1-1.5), p = 0.03). A composite score of pain and opioid use in the PACU favoured deep NMB (p = 0.001). CONCLUSIONS: In bariatric surgery, deep relaxation has advantages for surgeon and patient. Compared to moderate NMB, deep NMB produced stable and improved surgical conditions with less postoperative pain.

The Effect of Roux-en-Y Gastric Bypass Surgery in Morbidly Obese Patients on Pharmacokinetics of (Acetyl)Salicylic Acid and Omeprazole: the ERY-PAO Study.

BACKGROUND: Data on the absorption of orally administered drugs following Roux-en-Y gastric bypass (RYGB) surgery in obese patients are limited and inconclusive. As it is difficult to predict changes in absorption, studies on frequently used drugs in this population are necessary. Acetylsalicylic acid (ASA) and omeprazole are two commonly prescribed drugs in obese patients. METHODS: In this repeated measures study, omeprazole and salicylic acid (SA) serum concentrations were measured before and after RYGB in 34 morbidly obese subjects. Time to maximum concentration (Tmax), lag time (Tlag), maximum concentration (Cmax), and area under the serum concentration versus time curve (AUC) were calculated for both drugs to determine possible differences in drug absorption after the procedure. RESULTS: For SA, Tmax significantly decreased after RYGB, while both Cmax and AUC0-24 significantly increased. For omeprazole, both Tmax and Tlag significantly decreased after RYGB, while Cmax significantly increased. Mean AUC0-12 significantly decreased post-surgery. The difference in AUC0-12 before and after surgery varied between subjects. CONCLUSIONS: Our study shows a faster absorption of both ASA and omeprazole after RYGB. The exposure to ASA is higher post-surgery, but the standard dose of 80 mg does not need to be modified, considering its range in effective dose. The exposure to omeprazole is, on average, decreased after surgery. Clinicians should be aware to increase the dose of omeprazole if symptoms suggest inadequate response.

Roux-en-Y gastric bypass surgery, but not calorie restriction, reduces plasma branched-chain amino acids in obese women independent of weight loss or the presence of type 2 diabetes.

OBJECTIVE: Obesity and type 2 diabetes mellitus (T2DM) have been associated with increased levels of circulating branched-chain amino acids (BCAAs) that may be involved in the pathogenesis of insulin resistance. However, weight loss has not been consistently associated with the reduction of BCAA levels. RESEARCH DESIGN AND METHODS: We included 30 obese normal glucose-tolerant (NGT) subjects, 32 obese subjects with T2DM, and 12 lean female subjects. Obese subjects underwent either a restrictive procedure (gastric banding [GB], a very low-calorie diet [VLCD]), or a restrictive/bypass procedure (Roux-en-Y gastric bypass [RYGB] surgery). Fasting blood samples were taken for the determination of amine group containing metabolites 4 weeks before, as well as 3 weeks and 3 months after the intervention. RESULTS: BCAA levels were higher in T2DM subjects, but not in NGT subjects, compared with lean subjects. Principal component (PC) analysis revealed a concise PC consisting of all BCAAs, which showed a correlation with measures of insulin sensitivity and glucose tolerance. Only after the RYGB procedure, and at both 3 weeks and 3 months, were circulating BCAA levels reduced. CONCLUSIONS: Our data confirm an association between deregulation of BCAA metabolism in plasma and insulin resistance and glucose intolerance. Three weeks after undergoing RYGB surgery, a significant decrease in BCAAs in both NGT as well as T2DM subjects was observed. After 3 months, despite inducing significant weight loss, neither GB nor VLCD induced a reduction in BCAA levels. Our results indicate that the bypass procedure of RYGB surgery, independent of weight loss or the presence of T2DM, reduces BCAA levels in obese subjects.

Calorie restriction and Roux-en-Y gastric bypass have opposing effects on circulating FGF21 in morbidly obese subjects.

OBJECTIVE: To study the effect of different weight loss strategies on levels of the metabolic regulator FGF21 in morbidly obese females with normal glucose tolerance (NGT) or type 2 diabetes mellitus (T2DM). DESIGN: Observational intervention trial. PATIENTS AND MEASUREMENTS: Weight reduction was achieved by Gastric Banding (GB, n = 11) or Roux-en-Y Gastric Bypass (RYGB, n = 16) in subjects with NGT, and by RYGB (n = 15) or a very-low-calorie diet (VLCD, n = 12) in type 2 diabetics. Fasted and/or postprandial levels of FGF21, FGF19 (an FGF21-related postprandial hormone) and bile salts (implicated in regulation of FGF21 and FGF19 expression) were measured before, and 3 and 12 weeks after intervention. RESULTS: Fasted FGF21 levels were elevated in T2DM subjects. Calorie restriction by either GB or VLCD lowered bile salt and FGF21 levels. In contrast, RYGB surgery was associated with elevated bile salt and FGF21 levels. CONCLUSIONS: Calorie restriction and RYGB have opposite effects on serum bile salt and FGF21 levels. Calorie restriction results in FGF21 approaching nonobese control levels, suggesting that this intervention is effective in reducing the "nutritional crisis" that appears to underly FGF21 elevation in obesity. FGF21 elevation after RYGB may contribute to the beneficial effect of this procedure.

Calorie restriction is a major determinant of the short-term metabolic effects of gastric bypass surgery in obese type 2 diabetic patients.

OBJECTIVE: Roux-en-Y gastric bypass (RYGB) and restrictive weight loss interventions, such as gastric banding (GB) and very-low-calorie diets (VLCD) directly impact glucose metabolism, possibly by calorie restriction and/or altered secretion of gut hormones. We aimed to establish the direct endocrine and metabolic effects of RYGB compared to restrictive interventions in obese glucose-tolerant (NGT) subjects and subjects with type 2 diabetes (T2DM). DESIGN: Controlled, nonrandomized observational trial. PATIENTS AND MEASUREMENTS: Four groups of obese females received a mixed meal at baseline and 3 weeks after intervention; NGT-GB (n = 11), NGT-RYGB (n = 16), T2DM-RYGB (n = 15) and T2DM-VLCD (n = 12). Normal weight controls (n = 12) were studied once. RESULTS: At baseline, all obese subjects were hyperinsulinemic. T2DM was associated with hyperglycaemia and decreased GLP-1 levels. RYGB and VLCD reduced glucose levels to a similar extent in T2DM, insulin levels decreased only after VLCD. Comparison of restrictive intervention vs RYGB showed a more pronounced decrease in glucose and insulin AUC after restriction. In NGT and T2DM subjects, RYGB increased GLP-1 and PYY levels and decreased ghrelin levels, whereas VLCD and GB only increased GIP levels. CONCLUSIONS: These data indicate that deterioration of glucose metabolism in T2DM is associated with a decline of GLP-1 levels. Calorie restriction facilitates glucose metabolism and blunts hyperinsulinemia in obese (diabetic) humans. Additional duodenal exclusion through RYGB induces gut hormone release and hyperinsulinemia but does not improve postprandial glucose levels any further. Our data thus strongly suggest that calorie restriction underlies the short-term metabolic benefits of RYGB in obese T2DM patients.

Autonomic nervous system activity in diabetic and healthy obese female subjects and the effect of distinct weight loss strategies.

OBJECTIVE: Obesity and type 2 diabetes mellitus (T2DM) are reported to be associated with relative overactivity of the sympathetic nervous system (SNS), which is reversible by weight loss. However, direct effects of weight loss by calorie restriction vs Roux-en-Y gastric bypass (RYGB) on SNS overactivity were not studied in parallel. This study compared the effects of RYGB vs restrictive weight loss in obese patients with normal glucose tolerance (NGT) and with T2DM on SNS function as measured by heart rate variability (HRV). DESIGN AND METHODS: Lean (n=12), obese NGT (n=27) and T2DM (n=27) subjects were included in this study. Weight reduction in NGT subjects was achieved by gastric banding (GB) or RYGB and in T2DM subjects by RYGB or high-protein very-low-calorie diet (VLCD). HRV analysis was performed and blood samples were taken at baseline, 3 weeks and 3 months after intervention. RESULTS: At baseline, T2DM subjects showed SNS overactivity and NGT subjects showed similar, but non-significant, findings when compared with lean controls. Weight loss after 3 weeks was comparable in all treatment groups, whereas after 3 months, weight loss was most in VLCD and RYGB subjects. RYGB and VLCD treatment reduced SNS activity within 3 weeks in T2DM patients. After 3 months, restoration to normal autonomic nervous system activity was evident for all groups, except for the NGT-GB group. CONCLUSION: We can conclude that SNS overactivity is more pronounced in obese T2DM subjects when compared with NGT subjects. Reduction of SNS overactivity coincides with weight loss with the time-course of reduction dependent on the type of intervention. Surgery or caloric restriction may transiently induce SNS overactivity but do not prevent a direct restoration of sympathovagal balance.

Hook plate fixation of acute displaced lateral clavicle fractures: mid-term results and a brief literature overview.

BACKGROUND: The clavicle hook plate achieves like most other operative techniques, a high percentage of union and a low percentage of complications however concerns about long term complications still exist, particularly the involvement of the acromioclavicular joint. METHODS: To evaluate the results and long term effects in use of this plate we performed a retrospective analysis with a mean follow up of 65 months (5.4 years) of 28 consecutive patients with acute displaced lateral clavicle fractures, treated with the clavicle hook plate. RESULTS: Short term functional results in all patients were good to excellent. All but one patient had a united fracture (96%). Nine patients (32%) developed impingement symptoms and in 7 patients (25%) subacromial osteolysis was found. These findings resolved after plate removal. Twenty-four patients were re-evaluated at a mean follow-up period of 5.4 years. The Constant-Murley score was 97 and the DASH score was 3.5. Four patients (14%) developed acromioclavicular joint arthrosis of which one was symptomatic. Three patients (11%) had extra articular ossifications of which one was symptomatic. There was no relation between the impingement symptoms, subacromial osteolysis and development of acromioclavicular joint arthrosis or extra articular ossifications. CONCLUSIONS: The clavicle hook plate is a good primary treatment option for the acute displaced lateral clavicle fracture with few complications. At mid term the results are excellent and no long term complications can be addressed to the use of the plate.

The ladies trial: laparoscopic peritoneal lavage or resection for purulent peritonitis and Hartmann's procedure or resection with primary anastomosis for purulent or faecal peritonitis in perforated diverticulitis (NTR2037).

BACKGROUND: Recently, excellent results are reported on laparoscopic lavage in patients with purulent perforated diverticulitis as an alternative for sigmoidectomy and ostomy.The objective of this study is to determine whether LaparOscopic LAvage and drainage is a safe and effective treatment for patients with purulent peritonitis (LOLA-arm) and to determine the optimal resectional strategy in patients with a purulent or faecal peritonitis (DIVA-arm: perforated DIVerticulitis: sigmoidresection with or without Anastomosis). METHODS/DESIGN: In this multicentre randomised trial all patients with perforated diverticulitis are included. Upon laparoscopy, patients with purulent peritonitis are treated with laparoscopic lavage and drainage, Hartmann's procedure or sigmoidectomy with primary anastomosis in a ratio of 2:1:1 (LOLA-arm). Patients with faecal peritonitis will be randomised 1:1 between Hartmann's procedure and resection with primary anastomosis (DIVA-arm). The primary combined endpoint of the LOLA-arm is major morbidity and mortality. A sample size of 132:66:66 patients will be able to detect a difference in the primary endpoint from 25% in resectional groups compared to 10% in the laparoscopic lavage group (two sided alpha = 5%, power = 90%). Endpoint of the DIVA-arm is stoma free survival one year after initial surgery. In this arm 212 patients are needed to significantly demonstrate a difference of 30% (log rank test two sided alpha = 5% and power = 90%) in favour of the patients with resection with primary anastomosis. Secondary endpoints for both arms are the number of days alive and outside the hospital, health related quality of life, health care utilisation and associated costs. DISCUSSION: The Ladies trial is a nationwide multicentre randomised trial on perforated diverticulitis that will provide evidence on the merits of laparoscopic lavage and drainage for purulent generalised peritonitis and on the optimal resectional strategy for both purulent and faecal generalised peritonitis. TRIAL REGISTRATION: Nederlands Trial Register NTR2037.

The role of optical access trocars in laparoscopic surgery.

A literature review between 2000 and 2005 has been conducted for laparoscopic access techniques. The blind insertion of a Veress needle or first trocar to create the pneumoperitoneum has been shown to cause vascular and visceral injuries. To reduce the risk of peritoneal entry, many surgeons prefer an open-access technique, like a Hasson trocar. Other trocars that can be used for laparoscopic entry are direct trocars and radially expanding trocars. No specific technique has been shown to be superior in preventing vascular and visceral complications. Optical trocars combine the advantages of the different entry techniques. This chapter describes the different entry techniques, indications, and clinical experiences of the optical trocars. An optical trocar provides a safe and feasible primary insertion method for laparoscopy in patients prone to access injuries.