Guy J. Maddern

Laparoscopic adjustable gastric banding in the treatment of obesity: A systematic literature review

BACKGROUND We attempted to compare the safety and efficacy of laparoscopic adjustable gastric banding with vertical-banded gastroplasty and gastric bypass. Morbid obesity presents a serious health issue for Western countries, with a rising incidence and a strong association with increased mortality and serious comorbidities, such as diabetes, hyperlipidemia, and cardiovascular disease. Unfortunately, conservative treatment options have proven ineffective. Surgical interventions, such as vertical-banded gastroplasty (stomach stapling), Roux-en-Y gastric bypass, and, more recently, laparoscopic gastric banding have been developed with the aim of providing a laparoscopically placed device that is safe and effective in generating substantial weight loss. METHODS Electronic databases were systematically searched for references relating to obesity surgery by (1) laparoscopic adjustable gastric banding (LAGB), (2) vertical banded gastroplasty (VBG), and (3) Roux-en-Y gastric bypass (RYGB). RESULTS Only 6 studies reported comparative results for laparoscopic gastric banding and other surgical procedures. One study reported comparative results for all 3 surgical procedures, and this study was only of moderate quality. In total, 64 studies were found that reported results for LAGB and 57 studies reported results on the comparative procedures. LAGB was associated with a mean short-term mortality rate of approximately 0.05% and an overall median morbidity rate of approximately 11.3%, compared with 0.50% and 23.6% for RYGB, and 0.31% and 25.7% for VBG. Overall, all 3 procedures produced considerable weight loss in patients up to 4 years in the case of LAGB (the maximum follow-up available at the time of the review), and more than 10 years in the case of the comparator procedures. CONCLUSIONS The Australian Safety and Efficacy Register of New Interventional Procedures-Surgical Review Group concluded that the evidence base was of average quality up to 4 years for LAGB. Laparoscopic gastric banding is safer than VBG and RYGB, in terms of short-term mortality rates. LAGB is effective, at least up to 4 years, as are the comparator procedures. Up to 2 years, LAGB results in less weight loss than RYGB; from 2 to 4 years there is no significant difference between LAGB and RYGB, but the quality of data is only moderate. The long-term efficacy of LAGB remains unproven, and evaluation by randomized controlled trials is recommended to define its merits relative to the comparator procedures.

A systematic review of skills transfer after surgical simulation training.

Objective:To determine whether skills acquired by simulation-based training transfer to the operative setting. Summary Background Data:The fundamental assumption of simulation-based training is that skills acquired in simulated settings are directly transferable to the operating room, yet little evidence has focused on correlating simulated performance with actual surgical performance. Methods:A systematic search strategy was used to retrieve relevant studies. Inclusion of articles was determined using a predetermined protocol, independent assessment by 2 reviewers, and a final consensus decision. Only studies that reported on the use of simulation-based training for surgical skills training, and the transferability of these skills to the operative setting, were included. Results:Ten randomized controlled trials and 1 nonrandomized comparative study were included in this review. In most cases, simulation-based training was in addition to normal training programs. Only 1 study compared simulation-based training with patient-based training. For laparoscopic cholecystectomy and colonoscopy/sigmoidoscopy, participants who received simulation-based training before undergoing patient-based assessment performed better than their counterparts who did not receive previous simulation training, but improvement was not demonstrated for all measured parameters. Conclusions:Skills acquired by simulation-based training seem to be transferable to the operative setting. The studies included in this review were of variable quality and did not use comparable simulation-based training methodologies, which limited the strength of the conclusions. More studies are required to strengthen the evidence base and to provide the evidence needed to determine the extent to which simulation should become a part of surgical training programs.

Surgical simulation: a systematic review.

Objective:To evaluate the effectiveness of surgical simulation compared with other methods of surgical training. Summary Background Data:Surgical simulation (with or without computers) is attractive because it avoids the use of patients for skills practice and provides relevant technical training for trainees before they operate on humans. Methods:Studies were identified through searches of MEDLINE, EMBASE, the Cochrane Library, and other databases until April 2005. Included studies must have been randomized controlled trials (RCTs) assessing any training technique using at least some elements of surgical simulation, which reported measures of surgical task performance. Results:Thirty RCTs with 760 participants were able to be included, although the quality of the RCTs was often poor. Computer simulation generally showed better results than no training at all (and than physical trainer/model training in one RCT), but was not convincingly superior to standard training (such as surgical drills) or video simulation (particularly when assessed by operative performance). Video simulation did not show consistently better results than groups with no training at all, and there were not enough data to determine if video simulation was better than standard training or the use of models. Model simulation may have been better than standard training, and cadaver training may have been better than model training. Conclusions:While there may be compelling reasons to reduce reliance on patients, cadavers, and animals for surgical training, none of the methods of simulated training has yet been shown to be better than other forms of surgical training.

Evaluation and stages of surgical innovations

Surgical innovation is an important part of surgical practice. Its assessment is complex because of idiosyncrasies related to surgical practice, but necessary so that introduction and adoption of surgical innovations can derive from evidence-based principles rather than trial and error. A regulatory framework is also desirable to protect patients against the potential harms of any novel procedure. In this first of three Series papers on surgical innovation and evaluation, we propose a five-stage paradigm to describe the development of innovative surgical procedures.

Self-expanding metallic stents for relieving malignant colorectal obstruction: a systematic review.

Objective:To assess the safety and efficacy of self-expanding metallic stents (SEMS) placement for the relief of malignant colorectal obstruction in comparison to surgical procedures through a systematic review of the literature. Summary Background Data:Conventional therapies for relieving colorectal obstructions caused by cancer have high rates of morbidity and mortality, particularly when performed under emergency conditions, and palliative procedures resulting in colostomy creation can be a burden for patients and caregivers. Methods:A systematic search strategy was used to retrieve relevant studies. Inclusion of papers was established through application of a predetermined protocol, independent assessment by 2 reviewers, and a final consensus decision. Eighty-eight articles, 15 of which were comparative, formed the evidence base for this review. Results:Little high-level evidence was available. However, the data suggested that SEMS placement was safe and effective in overcoming left-sided malignant colorectal obstructions, regardless of the indication for stent placement or the etiology of the obstruction. Additionally, SEMS placement had positive outcomes when compared with surgery, including overall shorter hospital stays, and a lower rate of serious adverse events. Postoperative mortality appeared comparable between the 2 interventions. Combining SEMS placement with elective surgery also appeared safer and more effective than emergency surgery, with higher rates of primary anastomosis, lower rates of colostomy, shorter hospital stays, and lower overall complication rates. Conclusions:Stenting appears to be a safe and effective addition to the armamentarium of treatment options for colorectal obstructions. However, the small sample sizes of the included studies limited the validity of the findings of this review. The results of additional comparative studies currently being undertaken will add to the certainty of the conclusions that can be drawn.

A Systematic Review of Strategies to Improve Prophylaxis for Venous Thromboembolism in Hospitals

Objective:To assess the effectiveness of different strategies for increasing the uptake of prophylaxis for venous thromboembolism (VTE) in hospitalized patients through a systematic review of the literature. Methods:Literature databases and the Internet were searched from 1996 to May 2003. Studies of strategies to improve VTE prophylaxis practice were included. Studies where no policy or guideline was implemented or where the focus of the study was not VTE prevention were excluded. Results:Thirty studies were included. The quality of the available evidence was average with the majority of studies being uncontrolled before and after design and thus limited by the historical nature of much of the available data. Adherence to guidelines and the provision of adequate prophylaxis were poor in studies which relied on passive dissemination of guidelines. In general, the use of multiple strategies was more effective than a single strategy used in isolation. The most effective strategies incorporated a system for reminding clinicians to assess patients for VTE risk, either electronic decision-support systems or paper-based reminders, and used audit and feedback to facilitate the iterative refinement of the intervention. There were no studies adequately powered to demonstrate a reduction in rates of VTE. Insufficient evidence was available to make useful comparisons of strategies in terms of costs and resource utilization. Conclusions:Passive dissemination of guidelines is unlikely to improve VTE prophylaxis practice. A number of active strategies used together, which incorporate some method for reminding clinicians to assess patients for DVT risk and assisting the selection of appropriate prophylaxis, are likely to result in the achievement of optimal outcomes.

Transanal Endoscopic Microsurgery: A Systematic Review

PURPOSEThe aim of this study was to systematically review the evidence relating to the safety and efficacy of transanal endoscopic microsurgery, a relatively new technique used to locally excise rectal tumors, compared with existing techniques such as anterior resections and abdominoperineal resections or local excisions.METHODSWe conducted a systematic review of comparative studies and case series of transanal endoscopic microsurgery from 1980 to August 2002.RESULTSThree comparative studies (including one randomized, controlled trial) and 55 case series were included. The first area of study was the safety and efficacy of adenomas. In the randomized, controlled trial, no difference could be detected in the rate of early complications between transanal endoscopic microsurgery (10.3 percent) and direct local excision (17 percent) (relative risk, 0.61; 95 percent confidence interval, 0.29–1.29). Transanal endoscopic microsurgery resulted in less local recurrence (6/98; 6 percent) than direct local excision (20/90; 22 percent) (relative risk, 0.28; 95 percent confidence interval, 0.12–0.66). The 6 percent rate of local recurrence for transanal endoscopic microsurgery in this trial is consistent with the rates found in case series of transanal endoscopic microsurgery (median, 5 percent). The second area of study was the safety and efficacy of carcinomas. In the randomized, controlled trial, no difference could be detected in the rate of complications between transanal endoscopic microsurgery and direct local excision (relative risk for overall early complication rates, 0.56; 95 percent confidence interval, 0.22–1.42). No differences in survival or local recurrence rate between transanal endoscopic microsurgery and anterior resection could be detected in either the randomized, controlled trial (hazard ratio,1.02 for survival) or the nonrandomized, comparative study. There were 2 of 25 (8 percent) transanal endoscopic microsurgery recurrences in the randomized, controlled trial, but no figures were given for recurrence after anterior resection. In the case series, the median local recurrence rate for transanal endoscopic microsurgery was 8.4 percent, ranging from 0 percent to 50 percent. The third comparison was cost of the procedures. Transanal endoscopic microsurgery had both a lower recurrence rate and a lower cost than local excision or anterior resection for adenomas. Although the effectiveness of transanal endoscopic microsurgery could not be established for carcinomas, costs were lower than those for either anterior resection or abdominoperineal resection.CONCLUSIONSThe evidence regarding transanal endoscopic microsurgery is very limited, being largely based on a single relatively small randomized, controlled trial. However, transanal endoscopic microsurgery does appear to result in fewer recurrences than those with direct local excision in adenomas and thus may be a useful procedure for several small niches of patient types—e.g., for large benign lesions of the middle to upper third of the rectum, for T1 low-risk rectal cancers, and for palliative, not curative, use in more advanced tumors.

Living donor liver transplantation—Adult donor outcomes: A systematic review

The objective of this study was to evaluate the safety and efficacy of adult‐to‐adult living donor liver transplantation, specifically donor outcomes. A systematic review, with searches of the literature up to January 2004, was undertaken. Two hundred and fourteen studies provided information on donor outcomes. The majority of these were case series studies, although there were also studies comparing living donor liver transplantation with deceased donor liver transplantation. Both underreporting and duplicate reporting is likely to have occurred, and so caution is required in interpretation of these results. Overall reported donor mortality was 12 to 13 in about 6,000 procedures (0.2%) (117 studies). Mortality for right lobe donors to adult recipients is estimated to be 2 to 8 out of 3,800 (0.23 to 0.5%). The donor morbidity rate ranged from 0% to 100% with a median of 16% (131 studies). Biliary complications and infections were the most commonly reported donor morbidities. Nearly all donors had returned to normal function by 3 to 6 months (18 studies). In conclusion, there are small, but real, risks for living liver donors. Due to the short history of adult‐to‐adult living donor liver transplantation, the long‐term risks for donors are unknown. Liver Transpl 12:24–30, 2006.

Systematic review and meta-analysis of survival and disease recurrence after radiofrequency ablation for hepatocellular carcinoma.

Despite being one of the commonest causes of cancer‐related death around the world, only 20 per cent of hepatocellular carcinomas (HCCs) are amenable to curative treatment (surgical resection or liver transplantation). Radiofrequency ablation (RFA) has emerged as a popular therapy for unresectable HCC. There is evidence that the disparity in survival after curative RFA and surgery for HCC, especially tumours smaller than 3 cm in diameter, is narrowing. This review examined the survival and disease recurrence rates after RFA for HCC over the past decade.

A review of natural orifice translumenal endoscopic surgery (NOTES) for intra-abdominal surgery: experimental models, techniques, and applicability to the clinical setting.

Objective:Evaluation of models, techniques, outcomes, pitfalls, and applicability to the clinical setting of natural orifice translumenal endoscopic surgery (NOTES) for performing intra-abdominal surgery through a systematic review of the literature. Summary Background Data:NOTES has attracted much recent attention for its potential to allow traditional surgical procedures to be performed entirely through a natural orifice. Amid the excitement for potentially scar-free surgery and abolishment of dermal incision-related complications, the safety and efficacy of this new surgical technology must be evaluated. Methods:Studies were identified by searching MEDLINE, EMBASE, CINAHL, Current Contents, Cochrane Library, Entrez PubMed, Clinical Trials Database, National Health Services Centre for Reviews and Dissemination (NHS CRD) databases, and National Research Register from 2000 to June 2007. Studies identified in September 2007 were included if they were performed in live human subjects. Results:Of the 34 studies included for review, 30 were experimental studies conducted in animals, thus the evidence base was very limited. Although intra-abdominal access could be achieved reliably via oral, anal, or urethral orifices, the optimal access route and method could not be established. Viscerotomy closure could not be achieved reliably in all cases and risk of peritoneal infection has not been adequately minimized. Although the majority of interventions could be performed in animals using NOTES, a number of technical problems were encountered that need to be resolved. Conclusions:NOTES is still in early stages of development and more robust technologies will be needed to achieve reliable closure and overcome technical challenges. Well-managed human studies need to be conducted to determine the safety and efficacy of NOTES in a clinical setting.