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Health Technology Assessment... Sep 2009To assess the clinical effectiveness and cost-effectiveness of bariatric surgery for obesity. (Review)
Review
OBJECTIVES
To assess the clinical effectiveness and cost-effectiveness of bariatric surgery for obesity.
DATA SOURCES
Seventeen electronic databases were searched [MEDLINE; EMBASE; PreMedline In-Process & Other Non-Indexed Citations; The Cochrane Library including the Cochrane Systematic Reviews Database, Cochrane Controlled Trials Register, DARE, NHS EED and HTA databases; Web of Knowledge Science Citation Index (SCI); Web of Knowledge ISI Proceedings; PsycInfo; CRD databases; BIOSIS; and databases listing ongoing clinical trials] from inception to August 2008. Bibliographies of related papers were assessed and experts were contacted to identify additional published and unpublished references.
REVIEW METHODS
Two reviewers independently screened titles and abstracts for eligibility. Inclusion criteria were applied to the full text using a standard form. Interventions investigated were open and laparoscopic bariatric surgical procedures in widespread current use compared with one another and with non-surgical interventions. Population comprised adult patients with body mass index (BMI) > or = 30 and young obese people. Main outcomes were at least one of the following after at least 12 months follow-up: measures of weight change; quality of life (QoL); perioperative and postoperative mortality and morbidity; change in obesity-related comorbidities; cost-effectiveness. Studies eligible for inclusion in the systematic review for comparisons of Surgery versus Surgery were RCTs. For comparisons of Surgery versus Non-surgical procedures eligible studies were RCTs, controlled clinical trials and prospective cohort studies (with a control cohort). Studies eligible for inclusion in the systematic review of cost-effectiveness were full cost-effectiveness analyses, cost-utility analyses, cost-benefit analyses and cost-consequence analyses. One reviewer performed data extraction, which was checked by two reviewers independently. Two reviewers independently applied quality assessment criteria and differences in opinion were resolved at each stage. Studies were synthesised through a narrative review with full tabulation of the results of all included studies. In the economic model the analysis was developed for three patient populations, those with BMI > or = 40; BMI > or = 30 and < 40 with Type 2 diabetes at baseline; and BMI > or = 30 and < 35. Models were applied with assumptions on costs and comorbidity.
RESULTS
A total of 5386 references were identified of which 26 were included in the clinical effectiveness review: three randomised controlled trials (RCTs) and three cohort studies compared surgery with non-surgical interventions and 20 RCTs compared different surgical procedures. Bariatric surgery was a more effective intervention for weight loss than non-surgical options. In one large cohort study weight loss was still apparent 10 years after surgery, whereas patients receiving conventional treatment had gained weight. Some measures of QoL improved after surgery, but not others. After surgery statistically fewer people had metabolic syndrome and there was higher remission of Type 2 diabetes than in non-surgical groups. In one large cohort study the incidence of three out of six comorbidities assessed 10 years after surgery was significantly reduced compared with conventional therapy. Gastric bypass (GBP) was more effective for weight loss than vertical banded gastroplasty (VBG) and adjustable gastric banding (AGB). Laparoscopic isolated sleeve gastrectomy (LISG) was more effective than AGB in one study. GBP and banded GBP led to similar weight loss and results for GBP versus LISG and VBG versus AGB were equivocal. All comparisons of open versus laparoscopic surgeries found similar weight losses in each group. Comorbidities after surgery improved in all groups, but with no significant differences between different surgical interventions. Adverse event reporting varied; mortality ranged from none to 10%. Adverse events from conventional therapy included intolerance to medication, acute cholecystitis and gastrointestinal problems. Major adverse events following surgery, some necessitating reoperation, included anastomosis leakage, pneumonia, pulmonary embolism, band slippage and band erosion. Bariatric surgery was cost-effective in comparison to non-surgical treatment in the reviewed published estimates of cost-effectiveness. However, these estimates are likely to be unreliable and not generalisable because of methodological shortcomings and the modelling assumptions made. Therefore a new economic model was developed. Surgical management was more costly than non-surgical management in each of the three patient populations analysed, but gave improved outcomes. For morbid obesity, incremental cost-effectiveness ratios (ICERs) (base case) ranged between 2000 pounds and 4000 pounds per QALY gained. They remained within the range regarded as cost-effective from an NHS decision-making perspective when assumptions for deterministic sensitivity analysis were changed. For BMI > or = 30 and 40, ICERs were 18,930 pounds at two years and 1397 pounds at 20 years, and for BMI > or = 30 and < 35, ICERs were 60,754 pounds at two years and 12,763 pounds at 20 years. Deterministic and probabilistic sensitivity analyses produced ICERs which were generally within the range considered cost-effective, particularly at the long twenty year time horizons, although for the BMI 30-35 group some ICERs were above the acceptable range.
CONCLUSIONS
Bariatric surgery appears to be a clinically effective and cost-effective intervention for moderately to severely obese people compared with non-surgical interventions. Uncertainties remain and further research is required to provide detailed data on patient QoL; impact of surgeon experience on outcome; late complications leading to reoperation; duration of comorbidity remission; resource use. Good-quality RCTs will provide evidence on bariatric surgery for young people and for adults with class I or class II obesity. New research must report on the resolution and/or development of comorbidities such as Type 2 diabetes and hypertension so that the potential benefits of early intervention can be assessed.
Topics: Adolescent; Adult; Aged; Aged, 80 and over; Bariatric Surgery; Cost-Benefit Analysis; Female; Humans; Male; Middle Aged; Obesity; Outcome Assessment, Health Care; Young Adult
PubMed: 19726018
DOI: 10.3310/hta13410 -
HPB : the Official Journal of the... May 2009Percutaneous cholecystostomy (PC) is an established low-mortality treatment option for elderly and critically ill patients with acute cholecystitis. The primary aim of...
OBJECTIVES
Percutaneous cholecystostomy (PC) is an established low-mortality treatment option for elderly and critically ill patients with acute cholecystitis. The primary aim of this review is to find out if there is any evidence in the literature to recommend PC rather than cholecystectomy for acute cholecystitis in the elderly population.
METHODS
In April 2007, a systematic electronic database search was performed on the subject of PC and cholecystectomy in the elderly population. After exclusions, 53 studies remained, comprising 1918 patients. Three papers described randomized controlled trials (RCTs), but none compared the outcomes of PC and cholecystectomy. A total of 19 papers on mortality after cholecystectomy in patients aged >65 years were identified.
RESULTS
Successful intervention was seen in 85.6% of patients with acute cholecystitis. A total of 40% of patients treated with PC were later cholecystectomized, with a mortality rate of 1.96%. Procedure mortality was 0.36%, but 30-day mortality rates were 15.4 % in patients treated with PC and 4.5% in those treated with acute cholecystectomy (P < 0.001).
CONCLUSIONS
There are no controlled studies evaluating the outcome of PC vs. cholecystectomy and the papers reviewed are of evidence grade C. It is not possible to make definitive recommendations regarding treatment by PC or cholecystectomy in elderly or critically ill patients with acute cholecystitis. Low mortality rates after cholecystectomy in elderly patients with acute cholecystitis have been reported in recent years and therefore we believe it is time to launch an RCT to address this issue.
PubMed: 19590646
DOI: 10.1111/j.1477-2574.2009.00052.x -
BMJ Clinical Evidence Dec 2008Of people admitted to hospital for biliary tract disease, 20% have acute cholecystitis. Up to the age of 50 years, acute calculous cholecystitis is three times more... (Review)
Review
INTRODUCTION
Of people admitted to hospital for biliary tract disease, 20% have acute cholecystitis. Up to the age of 50 years, acute calculous cholecystitis is three times more common in women than in men, and about 1.5 times more common in women than in men thereafter. About 95% of people with acute cholecystitis have gallstones. Optimal therapy for acute cholecystitis, based on timing and severity of presentation, remains controversial.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for acute cholecystitis? We searched: Medline, Embase, The Cochrane Library, and other important databases up to December 2006 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 12 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review we present information relating to the effectiveness and safety of the following interventions: early cholecystectomy, laparoscopic cholecystectomy, minilaparoscopic cholecystectomy, observation alone, and open cholecystectomy.
Topics: Acute Disease; Cholecystectomy; Cholecystectomy, Laparoscopic; Cholecystitis; Cholecystitis, Acute; Gallstones; Hospitalization; Humans; Severity of Illness Index; Treatment Outcome
PubMed: 19445789
DOI: No ID Found -
The Cochrane Database of Systematic... Apr 2007Cholecystectomy is the removal of gallbladder and is performed mainly for symptomatic gallstones. Although laparoscopic cholecystectomy is currently preferred over open... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Cholecystectomy is the removal of gallbladder and is performed mainly for symptomatic gallstones. Although laparoscopic cholecystectomy is currently preferred over open cholecystectomy for elective cholecystectomy, reports of randomised clinical trials comparing the choice of cholecystectomy (open or laparoscopic) in acute cholecystitis are still being conducted. Drainage in open cholecystectomy is a matter of considerable debate. Surgeons use drains primarily to prevent subhepatic abscess or bile peritonitis from an undrained bile leak. Critics of drain condemn drain use as it increases wound and chest infection.
OBJECTIVES
To assess the benefits and harms of routine abdominal drainage in uncomplicated open cholecystectomy.
SEARCH STRATEGY
We searched The Cochrane Hepato-Biliary Group Controlled Trials Register, the Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, and Science Citation Index Expanded until April 2006.
SELECTION CRITERIA
We included randomised clinical trials comparing 'no drain' versus 'drain' in patients who had undergone uncomplicated open cholecystectomy (irrespective of language, publication status, and the type of drain). Randomised clinical trials comparing one drain with another were also included.
DATA COLLECTION AND ANALYSIS
We collected the data on the characteristics and methodological quality of each trial, number of abdominal collections requiring different treatments, bile peritonitis, wound infection, chest complications, and hospital stay from each trial. We analysed the data with both the fixed-effect and the random-effects models using RevMan Analysis. For each outcome, we calculated the odds ratio (OR) with 95% confidence intervals (CI) based on intention-to-treat analysis.
MAIN RESULTS
Twenty eight trials involving 3659 patients were included. There were 20 comparisons of 'no drain' versus 'drain' and 12 comparisons of one drain with another. There was no statistically significant difference in mortality, bile peritonitis, total abdominal collections, abdominal collections requiring different treatments, or infected abdominal collections. 'No drain' group had statistically significant lower wound infection (OR 0.61, 95% CI 0.43 to 0.87) and statistically significant lower chest infection (OR 0.59, 95% CI 0.42 to 0.84) than drain group. We found no significant differences between different types of drains.
AUTHORS' CONCLUSIONS
Drains increase the harms to the patient without providing any additional benefit for patients undergoing open cholecystectomy and should be avoided in open cholecystectomy.
Topics: Cholecystectomy; Cholecystolithiasis; Drainage; Humans; Randomized Controlled Trials as Topic; Suction
PubMed: 17443609
DOI: 10.1002/14651858.CD006003.pub2