Excess Body Weight Loss is Associated with Nonpathological Gait Patterns in Women 4 to 5 Years After Bariatric Surgery

Background

This study examined relationships between excess body weight (EBW) loss and current gait and functional status in women 5 years after Roux-en-Y gastric bypass surgery.

Methods

Gait data were analyzed in nine female bariatric patients for relationships with longitudinal changes in weight, body composition, and physical function assessed by the Short Musculoskeletal Functional Assessment (SMFA) questionnaire and the timed “get-up-and-go” (TGUG) test. Gait characteristics in the bariatric sample were also compared to an age- and BMI-matched nonsurgical reference sample from the Fels Longitudinal Study.

Results

Bariatric patients lost an average of 36.4 kg (61.1 %) of EBW between preoperative and 5-year follow-up visits (P?<?0.01); SMFA function index scores and TGUG times also decreased (both P?<?0.01). Degree of EBW loss was correlated with less time spent in initial double support and more time in single support (both P?=?0.02), and for all gait variables, the bariatric sample fell within the 95 % confidence intervals of gait/EBW relationships in the reference sample.

Conclusions

Gait and function 5 years after bariatric surgery were characteristic of current weight, not preoperative obesity, suggesting that substantial, sustained recovery of physical function is possible with rapid surgical weight loss.     

Fast-track laparoscopic bariatric surgery: a systematic review

This study aimed to systematically evaluate the evidence-based literature on fast-track laparoscopic Roux-en-Y gastric bypass (LRYGB) and laparoscopic adjustable gastric banding (LAGB) to determine the feasibility and safety of fast-track laparoscopic bariatric surgery. A literature search of PubMed, EMBASE and Cochrane Library using the MeSH terms “bariatric surgery”, “ambulatory surgical procedures” and related terms as keywords was performed. The study included articles that reported on intended next-day discharge for LRYGB and same-day discharge for LAGB. Data were extracted on study design and size, patient demographics, patient-selection criteria, patient preparation, perioperative management, operative details, clinical outcomes, and follow-up. The review included 13 studies classified as level 3b or 4 evidence. There were seven studies that investigated LAGB, five studies investigated LRYGB and one study detailed outcomes from both LRYGB and LAGB. Next-day discharge rate ranged from 81 to 100 % for LRYGB. Same-day discharge rate ranged from 76 to 98 % for LAGB. In LRYGB and LAGB complication, re-admission and mortality rates (≤10.5, ≤7.5, ≤0.1 %, respectively) were comparable with the conventional perioperative care. From our results, the fast-track management of patients undergoing LRYGB and LAGB is feasible. With careful patient selection and preparation within high-volume centres, and application of care pathways including close outpatient follow-up, outcomes for fast-track bariatric procedures can compare favourably with those reported in the literature for standard management, but with decreased cost. However, further studies from independent researchers are required to determine the safety of a generalised adoption of this approach outside of dedicated bariatric units, and to formally demonstrate the cost-benefit of fast-track bariatric surgery.     

Effects of very low calorie diets on liver size and weight loss in the preoperative period of bariatric surgery: a systematic review

Restrictive diet implementation in bariatric surgery (BS) preoperative period is common, although its benefits are not well established. This study aimed to assess the effects of very low calorie diets (VLCD) on liver size and weight loss during BS preoperative period. Surgery-related complications were also assessed. A systematic review of the literature was performed. Terms such as “bariatric surgery” and “very low energy diet” were included in the search strategy. Inclusion criteria were adult patients (aged>18 yr); VLCD treatment in BS preoperative period (10 d to 12 wk); and assessment of 1 the following outcomes: weight loss, liver volume reduction, and surgical complications. There were 9 studies included (849 patients including 250 controls, 196 controls without VLCD). Of the studies, 3 were randomized clinical trials and 6 were observational studies. VLCD treatment led to weight loss (?2.8 to ?14.8 kg) and to liver size reduction by 5% to 20% of the initial volume. VLCD treatment did not significantly reduce perioperative complications. However, 1 study (n = 273) reported a protective effect 30 days after surgery. This systematic review found VLCD treatment led to significant weight loss and liver volume reduction when applied to patients with obesity in BS preoperative period. The effect of VLCD on surgical risks is not clear. Standardization of dietary characteristics is needed, because weight loss and decrease in liver size were not connected to higher caloric restriction. This is an important matter in clinical practice as to avoid unnecessary prolonged and/or excessive dietary restriction.     

Behavioural Interventions for Severe Obesity Before and/or After Bariatric Surgery: a Systematic Review and Meta-analysis

Background

Significant, sustained weight loss through conventional, non-surgical interventions is often unattainable for people with severe obesity (e.g. BMI ≥40 or ≥35 kg/m² with co-morbidities). Bariatric surgery is effective in treating severe obesity, but surgery alone without additional behaviour change management may not result in optimum long-term weight loss and maintenance. This systematic review and meta-analysis of randomised controlled trials evaluated the effectiveness of lifestyle interventions before and/or after bariatric surgery.

Methods

MEDLINE, Embase, Cochrane Central Register of Controlled Trials and clinical trials registers were searched for eligible studies. Key journals were handsearched. Last search date was on December 2014. Eligible interventions had the explicit aim of changing behaviour related to diet and/or physical activity, starting within 12 months of surgery, either pre- or post-operatively, and with at least 6 months’ follow-up. The primary outcome was weight change; secondary outcomes included surgical complications, quality of life and changes in co-morbidities. Random effect meta-analyses were undertaken. Study quality was assessed with the Cochrane Collaboration’s risk of bias tool.

Results

Eleven trials met the inclusion criteria. Behavioural interventions appear to improve weight loss at 12 months after bariatric surgery. Secondary outcome data were lacking and weight outcomes were reported inconsistently. Overall, the methodological quality of the identified trials was low.

Conclusions

The strength of evidence is limited by the relatively small number of trials identified and by their low methodological quality and short follow-up duration. Well-designed randomised controlled trials (RCTs) with long-term follow-up are required.

     

Does the use of bioabsorbable mesh for hiatal hernia repair at the time of bariatric surgery reduce recurrence rates? A meta-analysis

BackgroundAnywhere from 16% to 37% of patients undergoing bariatric and metabolic surgery are estimated to have a hiatal hernia. To address the lack of long-term data showing the efficacy of bioabsorbable mesh in reducing the recurrence of hiatal hernia in patients who undergo bariatric surgery, we evaluated the world literature and performed a meta-analysis.ObjectiveTo evaluate hiatal hernia recurrence rates after placement of bioabsorbable mesh in bariatric patients.SettingMeta-analysis of world literature.MethodsWe performed a literature search using PubMed and MEDLINE with search terms including “hiatal hernia recurrence,” “bariatric surgery,” “bioabsorbable mesh,” “Gore BIO-A,” and “trimethylene carbonate.” Analysis was conducted to compare surgical time, length of stay, recurrence rate, hernia size, and changes in body mass index before and after surgery between mesh-group (MG) and nonmesh (NM) patients. The meta-analysis was described using standardized mean difference, weighted mean difference, effect size, and 95% confidence interval (CI). An I² statistic was computed to assess heterogeneity.ResultsTwelve studies with 1351 patients were included in our meta-analysis. Four studies had both an MG and an NM group. There were 668 patients in the MG and 683 patients in the NM group. Hernia size noted in the NM group (7 cm²) was compared with that in the MG (6.5 cm²) (95% CI: 3.89–9.14; P = .86). The MG had fewer recurrences than the NM group (effect size, 2% versus 14%; 95% CI: –.26 to –.02; P = .027). The average follow-up was 28.8 months for the MG and 32.8 months for the NM group.ConclusionRepair with bioabsorbable mesh at the time of the index bariatric surgery is more effective at reducing the recurrence rate of hiatal hernia than suture cruroplasty. Further studies investigating the long-term outcomes of bioabsorbable mesh placed at the time of bariatric surgery are needed.     

The role of prospective randomized clinical trials in pediatric surgery: state of the art?

PURPOSE: This study sought to determine the role of randomized controlled trials (RCT) in the evolution of pediatric surgical practice. METHODS: The authors used a computer-assisted literature search to identify all clinical trials related to pediatric surgery published in the English-language literature from 1966 through 1999. Each article was reviewed in detail for purpose, content, conduct, and quality of the trial. The authors assessed quality with a previously validated instrument (Chalmers Qualitative Assessment). RESULTS: The authors identified 134 RCTs related to pediatric surgery over the past 33 years. This accounts for 0.17% of 80,377 articles published in the field. The areas of surgery studied were analgesia 65 (49%), antibiotics 17 (13%), extracorporeal membrane oxygenation (ECMO) 9 (7%), gastrointestinal, burns, oncology, minimally invasive surgery, vascular access, congenital anomalies, and trauma (each <5%). Only 16 (12%) trials compared 2 surgical therapies, 9 (7%) compared a medical versus a surgical therapy, and 109 (81%) compared 2 medical therapies in surgical patients. Fourteen (10%) RCTs were funded by peer-reviewed agencies. Only 17 (13%) RCTs included a biostatistician as an author or a consultant. Trial design included calculation of sample size and statistical power in 21 (16%) RCTs. Method of randomization was reported in only 51 (38%). The test statistic and observed probability value was reported in 15 (11%). CONCLUSIONS: Clinical trials are used infrequently to answer questions related to pediatric surgery. When RCTs are utilized, they often suffer from poor trial design, inadequate statistical analysis, and incomplete reporting. Pediatric surgery could benefit from increased expertise, funding, and participation in clinical trials.     

Bariatric surgery interest around the world: What Google Trends can teach us

BackgroundBariatric surgery may prove an effective weight loss option for those struggling with severe obesity, but it is difficult to determine levels of interest in such procedures at the population level through traditional approaches. Analysis of Google Trend information may give providers and healthcare systems useful information regarding Internet users’ interest in bariatric procedures. The objective of this study was to gather Google Trend information on worldwide Internet searches for “bariatric surgery”, “gastric bypass”, “gastric sleeve”, “gastric plication”, and “lap band” from 2004–2012 and to explore temporal relationships with relevant media events, economic variations, and policy modifications.MethodsData were collected using Google Trends. Trend analyses were performed using Microsoft Excel Version 14.3.5 and Minitab V.16.0.ResultsTrend analyses showed that total search volume for the term “bariatric surgery” has declined roughly 25% since January 2004, although interest increased approximately 5% from 2011 to 2012. Interest in lap band procedures declined 30% over the past 5 years, while “gastric sleeve” has increased 15%. Spikes in search numbers show an association with events such as changing policy and insurance guidelines and media coverage for bariatric procedures.ConclusionThis report illustrates that variations in Internet search volume for terms related to bariatric surgery are multifactorial in origin. Although it is impossible to ascertain if reported Internet search volume is based on interest in potentially undergoing bariatric surgery or simply general interest, this analysis reveals that search volume appears to mirror real world events. Therefore, Google Trends could be a way to supplement understanding about interest in bariatric procedures.     

Assurance of surgical quality within multicenter randomized controlled trials for bariatric and metabolic surgery: a systematic review

BackgroundSurgical quality assurance methods aim to ensure standardization and high quality of surgical techniques within multicenter randomized controlled trials (RCTs), thereby diminishing the heterogeneity of surgery and reducing biases due to surgical variation. This study aimed to establish the measures undertaken to ensure surgical quality within multicenter RCTs investigating bariatric and metabolic surgery, and their influence upon clinical outcomes.MethodsAn electronic literature search was performed from the Embase, Medline, and Web of Science databases to identify multicenter RCTs investigating bariatric and metabolic surgery. Each RCT was evaluated against a checklist of surgical quality measures within 3 domain: (1) standardization of surgical techniques; (2) credentialing of surgical experience; and (3) monitoring of performance. Outcome measures were postoperative weight change and complications.ResultsNineteen multicenter RCTs were included in the analysis. Three studies undertook pretrial education of surgical standard. Fourteen studies described complete standardization of surgical techniques. Four studies credentialed surgeons by case volume prior to enrollment. Two studies used intraoperative or video evaluation of surgical technique prior to enrollment. Only two studies monitored performance during the study. Although there were limited quality assurance methods undertaken, utilization of these techniques was associated with reduced overall complications. Standardization of surgery was associated with reduced re-operation rates but did not influence postoperative weight loss.ConclusionThe utilization of methods for surgical quality assurance are very limited within multicenter RCTs of bariatric and metabolic surgery. Future studies must implement surgical quality assurance methods to reduce variability of surgical performance and potential bias within RCTs.     

Effect of bariatric surgery on oncologic outcomes: a systematic review and meta-analysis

Background

Obesity is a major public health issue and is associated with increased risk of several cancers, currently a leading cause of mortality. Obese patients undergoing bariatric surgery may allow for evaluation of the effect of intentional excess weight loss on subsequent risk of cancer. We aimed to evaluate cancer risk, incidence, and mortality after bariatric surgery.

Methods

A comprehensive literature search was conducted using PubMed/MEDLINE and Embase with literature published from the inception of both databases to January 2012. Inclusion criteria incorporated all human studies examining oncologic outcomes after bariatric surgery. Two authors independently reviewed selected studies and relevant articles from their bibliographies for data extraction, quality appraisal, and meta-analysis.

Results

Six observational studies (n = 51,740) comparing relative risk (RR) of cancer in obese patients undergoing bariatric surgery versus obese control subjects were analyzed. Overall, the RR of cancer in obese patients after undergoing bariatric surgery was 0.55 [95 % confidence interval (CI) 0.41–0.73, p < 0.0001, I ² = 83 %]. The effect of bariatric surgery on cancer risk was modified by gender (p = 0.021). The pooled RR in women was 0.68 (95 % CI 0.60–0.77, p < 0.0001, I ² < 0.1 %) and in men was 0.99 (95 % CI 0.74–1.32, p = 0.937, I ² < 0.1 %).

Conclusions

Bariatric surgery reduces cancer risk and mortality in formerly obese patients. When stratifying the meta-analysis by gender, the effect of bariatric surgery on oncologic outcomes is protective in women but not in men.     

Reducing the risk of infection for transrectal prostate biopsy with povidone–iodine: a systematic review and meta-analysis

Purpose

To evaluate the efficacy of povidone–iodine (PI) in reducing the risk of infectious complications following transrectal prostate biopsy (TRPB).

Methods

Eligible randomized controlled trials (RCTs) were identified from electronic databases (Cochrane CENTRAL, MEDLINE, and EMBASE). The database search, quality assessment, and data extraction were performed independently by two reviewers. The main outcome for the efficacy of PI was the incidence of infectious complications after TRPB.

Results

Seven trials, including 2,049 patients, met the inclusion criteria. Data from the seven included RCTs favored the use of PI before TRPB to prevent infectious complications. PI for “PI versus blank control” significantly reduced fever, bacteriuria, and bacteremia compared with that for control [relative risk (RR) 0.31; 95 % confidence interval (CI) 0.21–0.45, P < 0.00001]. With PI versus antibiotics (ATB), patients treated with ATB alone had a significantly greater risk of bacteremia (RR 0.38; 95 % CI 0.16–0.90, P = 0.03). In “PI plus ATB versus ATB” trials, the risk of fever (RR 0.11; 95 % CI 0.02–0.85, P = 0.03) and bacteremia (RR 0.25; 95 % CI 0.08–0.75, P = 0.01) was diminished in the “PI plus ATB” group.

Conclusions

Rectal disinfection with PI provides a safe and effective method to reduce the risk of infectious complications following TRPB, regardless of mono-prophylaxis and combined prophylaxis with PI and ATB. Large, multicenter, and prospective RCTs of good quality trials are needed to confirm the efficacy of PI.     

Attitudes Towards Bariatric Surgery in the General Public

Background

Prevalence rates of obesity are still rising. Weight loss surgery (WLS) is the most invasive but also most effective treatment option when behavioral modification has failed. Research indicates that health care professionals hold ambivalent views on bariatric surgery, while views of the general public have not yet been investigated.

Methods

In a German representative sample of n?=?3,003 respondents in a computer-assisted telephone interview, n?=?1,008 persons were interviewed on their views of the effectiveness of bariatric surgery and other interventions for obesity. Also, willingness to recommend a treatment was assessed.

Results

Lifestyle-based interventions were viewed as most effective in terms of weight loss. About 50 % of the population stated that WLS is “very effective” while still a quarter of respondents did not ascribe effectiveness to WLS. Higher age was associated with lower expectations of effectiveness while higher stigmatizing attitudes and genetic attributes for obesity were associated with higher expectations of effectiveness. Seventy-two percent would not recommend WLS or undergo it, if applicable, themselves. Higher educated respondents and those that viewed WLS as effective were more likely to recommend WLS.

Conclusions

The German general public seems to be rather cautious regarding bariatric surgery. It may be assumed that false beliefs on the effectiveness and risk patterns of bariatric surgery are still very common, despite rising surgery numbers. Our results further emphasize the need for providing evidence-based information on bariatric surgery to the general public.     

Twenty-year perspective of randomized controlled trials for surgery of chronic nonspecific low back pain: citation bias and tangential knowledge

Background contextAfter decades of clinical research, the role of surgery for chronic nonspecific low back pain (CNLBP) remains equivocal. Despite significant intellectual, human, and economic investments into randomized controlled trials (RCTs) in the past two decades, the role of surgery in the treatment for CNLBP has not been clarified.PurposeTo delineate the historical research agenda of surgical RCTs for CNLBP performed between 1993 and 2012 investigating whether conclusions from earlier published trials influenced the choice of research questions of subsequent RCTs on elucidating the role of surgery in the management of CNLBP.Study designLiterature review.MethodsWe searched the literature for all RCTs involving surgery for CNLBP. We reviewed relevant studies to identify the study question, comparator arms, and sample size. Randomized controlled trials were classified as “indication” trials if they evaluated the effectiveness of surgical therapy versus nonoperative care or as “technical” if they compared different surgical techniques, adjuncts, or procedures. We used citation analysis to determine the impact of trials on subsequent research in the field.ResultsAltogether 33 technical RCTs (3,790 patients) and 6 indication RCTs (981 patients) have been performed. Since 2007, despite the unclear benefits of surgery reported by the first four indication trials published in 2001 to 2006, technical trials have continued to predominate (16 vs. 2). Of the technical trials, types of instrumentation (13 trials, 1,332 patients), bone graft materials and substitutes (11 trials, 833 patients), and disc arthroplasty versus fusion (5 trials, 1,337 patients) were the most common comparisons made. Surgeon authors have predominantly cited one of the indication trials that reported more favorable results for surgery, despite a lack of superior methodology or sample size. Trials evaluating bone morphogenic protein, instrumentation, and disc arthroplasty were all cited more frequently than the largest trial of surgical versus nonsurgical therapy.ConclusionsThe research agenda of RCTs for surgery of CNLBP has not changed substantially in the last 20 years. Technical trials evaluating nuances of surgical techniques significantly predominate. Despite the publication of four RCTs reporting equivocal benefits of surgery for CNLBP between 2001 and 2006, there was no change in the research agenda of subsequent RCTs, and technical trials continued to outnumber indication trials. Rather than clarifying what, if any, indications for surgery exist, investigators in the field continue to analyze variations in surgical technique, which will probably have relatively little impact on patient outcomes. As a result, clinicians unfortunately have little evidence to advise patients regarding surgical intervention for CNLBP.     

Diabetes and Weight in Comparative Studies of Bariatric Surgery vs Conventional Medical Therapy: A Systematic Review and Meta-Analysis

We performed a meta-analysis of weight loss and remission of type 2 diabetes mellitus (T2DM) evaluated in randomized controlled trials (RCTs) and observational studies of bariatric surgery vs conventional medical therapy. English articles published through June 10, 2013 that compared bariatric surgery with conventional therapy and included T2DM endpoints with ≥12-month follow-up were systematically reviewed. Body mass index (BMI, in kilogram per square meter), glycated hemoglobin (HbA_1C, in degree), and fasting plasma glucose (FPG, in milligram per deciliter) were analyzed by calculating weighted mean differences (WMDs) and pooled standardized mean differences and associated 95 % confidence intervals (95 % CI). Aggregated T2DM remission event data were analyzed by calculating the pooled odds ratio (POR) and 95 % CI. Random effects assumptions were applied throughout; I ²?≥?75.0 % was considered indicative of significant heterogeneity. Systematic review identified 512 articles: 47 duplicates were removed, 446 failed inclusion criteria (i.e., n?<?10 per arm, animal studies, reviews, case reports, abstracts, and kin studies). Of 19 eligible articles, two not focused on diagnosed T2DM and one with insufficient T2DM data were excluded. In the final 16 included papers, 3,076 patients (mean BMI, 40.9; age, 47.0; 72.0 % female) underwent bariatric surgery; 3,055 (39.4; 48.6, 69.0 %) received conventional or no weight-loss therapy. In bariatric surgery vs conventional therapy groups, the mean 17.3?±?5.7 month BMI WMD was 8.3 (7.0, 9.6; p?<?0.001; I ²?=?91.8), HbA_1C was 1.1 (0.6, 1.6; p?<?0.001; I ²?=?91.9), and FPG, 24.9 (15.9, 33.9; p?<?0.001; I ²?=?84.8), with significant differences favoring surgery. The overall T2DM remission rate for surgery vs conventional group was 63.5 vs 15.6 % (p?<?0.001). The Peto summary POR was 9.8 (6.1, 15.9); inverse variance summary POR was 15.8 (7.9, 31.4). Of the included studies, 94.0 % demonstrated a significant statistical advantage favoring surgery. In a meta-analysis of 16 studies (5 RCTs) with 6,131 patients and mean 17.3-month follow-up, bariatric surgery was significantly more effective than conventional medical therapy in achieving weight loss, HbA_1C and FPG reduction, and diabetes remission. The odds of bariatric surgery patients reaching T2DM remission ranged from 9.8 to 15.8 times the odds of patients treated with conventional therapy.     

Correlation between Postoperative Weight Loss and Diabetes Mellitus Remission: A Meta-Analysis

Objective

This meta-analysis was conducted to determine the effect of percent excess weight loss (%EWL) after bariatric surgery on diabetes remission.

Methods

The Cochrane Library, PubMed, MEDLINE, Embase, and CINAHL were searched. All reports on %EWL involving humans and published in English between 1 January 1992 and 1 September 2013 were included in the analysis.

Results

Eight studies involving 1,247 patients who underwent bariatric surgery were selected. %EWL was positively associated with remission rate (WMD?=?11.15, 95 % CI: 6.73–15.56, p?Conclusions Patients with extensive weight loss were more likely to achieve T2DM remission after bariatric surgery. Further randomized controlled trials (RCTs) with uniform remission criterion should be performed to provide more reliable evidence.     

Probiotics and Synbiotics Decrease Postoperative Sepsis in Elective Gastrointestinal Surgical Patients: a Meta-Analysis

Background

The health benefits of probiotics and synbiotics are well established in healthy adults, but their role in preventing postoperative sepsis remains controversial. This meta-analysis assesses the impact of probiotics and synbiotics on the incidence of postoperative sepsis in gastrointestinal (GI) surgical patients.

Methods

A comprehensive literature search of all published randomized control trials (RCTs) was conducted using PubMed, Cochrane Central Registry of Controlled Trials, and Google Scholar (1966–2015). Inclusion criteria included RCTs comparing the use of any strain or dose of a specified probiotic/synbiotic with placebo or a “no treatment” control group. The incidence of postoperative sepsis (within 1 month of surgery) and postoperative mortality were analyzed.

Results

Fifteen RCTs involving 1201 patients (192 receiving probiotics, 413 receiving synbiotics, and 596 receiving placebo) were analyzed. Overall, probiotic and synbiotic uses significantly reduced the risk of developing postoperative sepsis by 38 % (relative risk (RR)?=?0.62, 95 % confidence interval (CI) 0.52–0.74, p?<?0.001).

Conclusions

The use of probiotic/synbiotic supplementation is associated with a significant reduction in the risk of developing postoperative sepsis in patients undergoing elective GI surgery. Probiotic/synbiotic supplementation is a valuable adjunct in the care of patients undergoing GI surgery. Additional studies are required to determine the optimal dose and strain of probiotic/synbiotic.

     

The Results of a Surgical Complication Protection Program (BLIS, Inc.) for Private Pay Bariatric Patients in the U.S.: 2006–2011

Background

Bariatric surgery is the most effective treatment for morbid obesity and associated medical co morbidities. There is currently minimal surgical treatment penetration of this widespread disease. BLIS has been able to improve the access to bariatric surgery for cash-pay patients by alleviating concern about the costs of post-surgical complications. Recently, there has become an ability to attract payor groups by offering a “bundled” payment which includes BLIS complication protection.

Methods

A total of 5,364 self-pay patients underwent laparoscopic adjustable gastric banding, laparoscopic vertical sleeve gastrectomy, or laparoscopic Roux-en-Y gastric bypass with BLIS complication insurance.

Results

Of the overall 5,364 patients, the 30-day mortality rate was 0.04 % and 1-year mortality rate was 0.06 %. The frequency of complications was 5.4 % in the gastric banding group, 6.5 % in the sleeve gastrectomy group, and 9.7 % in the gastric bypass group.

Conclusions

The results for mortality and complications in the BLIS data set compares very well with other large data sets in bariatric surgery. BLIS complication insurance improves the access to bariatric surgery in patients who self-pay.     

Controlled Trials in Aesthetic Plastic Surgery: A 16-Year Analysis

Aesthetic surgery is one pillar of plastic surgery. Thus, not surprisingly, journals exist that focus predominantly on advances within this subspecialty. However, rarely has the process of systematic reviewing that identified randomized controlled trials (RCTs) and controlled clinical trials (CCTs) been conducted within this subspecialty. All original articles published in Aesthetic Plastic Surgery were analyzed to identify all RCTs and CCTs. The proportion of RCTs and CCTs in all original articles was determined, and the quality of reporting was assessed on the basis of established quality items. Additional parameters were investigated including reporting of statistically significant differences, type of institution, and country affiliation of the first author. Of the 1,048 original articles analyzed, 11 (1%) and 24 (2.3%) articles met the inclusion criteria for RCTs and CCTs, respectively. Only two studies were single blinded, whereas only one study reported on successful double blinding and appropriate allocation concealment. Notably, these trials were RCTs. Participant dropout was reported in one study. Statistically significant differences were reported in 18 trials, 6 of which were RCTs. The annual publication of RCTs has increased over the past 5 years. North America and Europe contributed a total of 28 controlled trials (80%). Controlled trials are being conducted in aesthetic surgery at a strikingly low rate. However, a recent increase in published RCTs reflects the recognition that performing outcome studies is pivotal in moving practice toward a foundation based on assessment by outcome. The quality of reporting, however, needs improvement.     

Efficacy of low-level laser therapy in the management of orthodontic pain: a systematic review and meta-analysis

This review aimed to identify the efficacy of low-level laser therapy (LLLT) in the management of orthodontic pain. This systematic review and meta-analysis was carried out in accordance with Cochrane Handbook and the PRISMA statement. An extensive literature search for RCTs, quasi-RCTs, and CCTs was performed through CENTRAL, PubMed, Embase, Medline, CNKI, and CBM up to October 2011. Risk of bias assessment was performed via referring to the Cochrane tool for risk of bias assessment. Meta-analysis was implemented using Review Manager 5.1. As a result, four RCTs, two quasi-RCTs, and two CCTs were selected from 152 relevant studies, including 641 patients from six countries. The meta-analysis demonstrated that 24 % risk of incidence of pain was reduced by LLLT (RR?=?0.76, 95 % CI range 0.63–0.92, P?=?0.006). In addition, compared to the control group, LLLT brought forward “the most painful day” (MD?=??0.42, 95 % CI range ?0.74–???0.10, P?=?0.009). Furthermore, the LLLT group also implied a trend of earlier end of pain compared with the control group (MD?=??1.37, 95 % CI range ?3.37–0.64, P?=?0.18) and the pseudo-laser group (MD?=??1.04, 95 % CI range ?4.22–2.15, P?=?0.52). However, because of the methodological shortcomings and risk of bias of included trials, LLLT was proved with limited evidence in delaying pain onset and reducing pain intensity. In the future, larger and better-designed RCTs will be required to provide clearer recommendations.