MNT: RDN in Medical Team (2015)
- Underwent laparoscopic adjustable gastric banding (LABG) between January 2011 and July 2007
- Qualified for surgery according to standards defined by the 1991 NIH Consensus Conference Statement of Gastrointestinal Surgery for Severe Obesity.
Recruited from physicians' offices.
- Data was collected prospectively for 838 consecutive morbidly obese patients who underweight LAGB between January 2001 and July 2007
- Patients were followed by a multi-disciplinary team consisting of a surgeon, physician, dietitian and exercise consultant, all of whom were involved in the process of data collection and evaluation of outcomes
- Follow-up included monthly visits with a member of the multi-disciplinary team for the first six months, at approximately nine months and 12 months and then biannually or as required
- Comorbidity and and QoL data after weight loss with gastric banding was collected and evaluated.
Swedish adjustable gastric band placement.
- Two-sided student's T-test was used to test significant differences between two samples of quantitative variables
- Analysis of variance (ANOVA) was used to test for differences in more than two groups
- Leven's test to determine homogeneity of variance between groups
- P<0.05 was considered statistically significant.
Timing of Measurements
- Fasting blood sugar levels, HbA1c and lipid concentrations were collected pre-operatively and follow-up values were obtained from the patient's treating endocrinologist or primary care physician or as part of the routine laboratory measurements performed at the clinic
- Number, dose and frequency of all hypoglycemic and insulin requirements, anti-hypertensive, lipid-lowering, asthma, analgesics, anti-reflux and anti-depressant medications pre-operatively and post-operatively assessed at each follow-up visit in all patients with greater than six months of follow-up
- Improvement and resolution of comorbid illness identified by dose reduction in medication with improvement in specific laboratory values and evaluated throughout the study
- Weight evaluated at each follow-up time-point using the Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) and Beck Depression Inventory II (BDI-II)
- Quality of life perception and depressive mood were identified at baseline and during follow-up visits.
- Improvement in comorbid conditions
- Resolution of comorbid conditions
- Weight change
- Percentage of excess weight loss (EWL)
- Quality of life
- Depressive mood.
Independent VariablesGastric banding using the Swedish Adjustable Gastric Band (SABG).
838 patients (159 males, 679 females).
Attrition (Final N)
175 patients matured to 36-month follow-up.
- White: 97.1%
- Indian/Chinese: 1.4%
- Aboriginal: 0.2%
- Hispanic: 1.0%
- Pacific Island/Maori: 0.2%.
Other Relevant Demographics
- Height: 168±9cm
- Absolute weight: 122±25kg
- Ideal body weight: 63±7kg
- Excess body weight: 60±39kg
- BMI: 44±8 kg/m2.
- In the total consecutive group of patients, BMI decreased from 44±8kg/m2 to 32±7kg/m2 at 24 months and 32.7±7kg/m2 at 36 months (P<0.001). Percentage EWL in the same intervals was 52±16% (P<0.001) and 54±23% (P<0.001).
- For the entire cohort of 545 patients with comorbid illnesses, after a median follow-up of 13 months, precentage EWL was 26±17%, with a change in BMI of 5.0kg/m2 and an absolute weight loss of 15±8kg
- Of the 545 patients with comorbid illnesses under current review, weight loss was associated with comorbid illness improvement or resolution relative to baseline in all illnesses studied
- Pre-operatively, QoL scores in the eight domains were significantly lower in comparison with community norms, but after a median follow-up of 13 months, all eight domain scores increased significantly to within the range of QoL of individuals in the normal community
- Pre-operatively, 342 patients completed the BDI-II with a mean score of 17.3±10, indicating mild to moderate levels of depressive mood. After surgery, these patients experienced a significant fall in their BDI-II depression scores to a score within the normal range of 7.2±6 (P<0.001).
Absolute Weight, kg
Resolution or improvement of Comorbidities at a Median Follow-Up of 13 Months
Range, six months to 36 months
Percentage Resolution or Improvement
- LAGB using the SAGB is an effective method for achieving and maintaining substantial weight loss in the majority of morbidly obese patients undergoing bariatric surgery
- After gastric banding, morbidly obese patients experienced marked weight loss in addition to a reduction of the major comorbid conditions that not only threaten their lives but significantly impair their daily QoL.
Quality Criteria Checklist: Primary Research
|1.||Would implementing the studied intervention or procedure (if found successful) result in improved outcomes for the patients/clients/population group? (Not Applicable for some epidemiological studies)||Yes|
|2.||Did the authors study an outcome (dependent variable) or topic that the patients/clients/population group would care about?||Yes|
|3.||Is the focus of the intervention or procedure (independent variable) or topic of study a common issue of concern to dieteticspractice?||Yes|
|4.||Is the intervention or procedure feasible? (NA for some epidemiological studies)||Yes|
|1.||Was the research question clearly stated?||Yes|
|1.1.||Was (were) the specific intervention(s) or procedure(s) [independent variable(s)] identified?||Yes|
|1.2.||Was (were) the outcome(s) [dependent variable(s)] clearly indicated?||Yes|
|1.3.||Were the target population and setting specified?||Yes|
|2.||Was the selection of study subjects/patients free from bias?||Yes|
|2.1.||Were inclusion/exclusion criteria specified (e.g., risk, point in disease progression, diagnostic or prognosis criteria), and with sufficient detail and without omitting criteria critical to the study?||Yes|
|2.2.||Were criteria applied equally to all study groups?||Yes|
|2.3.||Were health, demographics, and other characteristics of subjects described?||Yes|
|2.4.||Were the subjects/patients a representative sample of the relevant population?||Yes|
|3.||Were study groups comparable?||Yes|
|3.1.||Was the method of assigning subjects/patients to groups described and unbiased? (Method of randomization identified if RCT)||N/A|
|3.2.||Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?||N/A|
|3.3.||Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)||N/A|
|3.4.||If cohort study or cross-sectional study, were groups comparable on important confounding factors and/or were preexisting differences accounted for by using appropriate adjustments in statistical analysis?||Yes|
|3.5.||If case control study, were potential confounding factors comparable for cases and controls? (If case series or trial with subjects serving as own control, this criterion is not applicable.)||N/A|
|3.6.||If diagnostic test, was there an independent blind comparison with an appropriate reference standard (e.g., "gold standard")?||N/A|
|4.||Was method of handling withdrawals described?||Yes|
|4.1.||Were follow-up methods described and the same for all groups?||Yes|
|4.2.||Was the number, characteristics of withdrawals (i.e., dropouts, lost to follow up, attrition rate) and/or response rate (cross-sectional studies) described for each group? (Follow up goal for a strong study is 80%.)||Yes|
|4.3.||Were all enrolled subjects/patients (in the original sample) accounted for?||Yes|
|4.4.||Were reasons for withdrawals similar across groups?||???|
|4.5.||If diagnostic test, was decision to perform reference test not dependent on results of test under study?||N/A|
|5.||Was blinding used to prevent introduction of bias?||Yes|
|5.1.||In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?||N/A|
|5.2.||Were data collectors blinded for outcomes assessment? (If outcome is measured using an objective test, such as a lab value, this criterion is assumed to be met.)||N/A|
|5.3.||In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?||Yes|
|5.4.||In case control study, was case definition explicit and case ascertainment not influenced by exposure status?||N/A|
|5.5.||In diagnostic study, were test results blinded to patient history and other test results?||N/A|
|6.||Were intervention/therapeutic regimens/exposure factor or procedure and any comparison(s) described in detail? Were interveningfactors described?||Yes|
|6.1.||In RCT or other intervention trial, were protocols described for all regimens studied?||N/A|
|6.2.||In observational study, were interventions, study settings, and clinicians/provider described?||Yes|
|6.3.||Was the intensity and duration of the intervention or exposure factor sufficient to produce a meaningful effect?||Yes|
|6.4.||Was the amount of exposure and, if relevant, subject/patient compliance measured?||Yes|
|6.5.||Were co-interventions (e.g., ancillary treatments, other therapies) described?||Yes|
|6.6.||Were extra or unplanned treatments described?||Yes|
|6.7.||Was the information for 6.4, 6.5, and 6.6 assessed the same way for all groups?||Yes|
|6.8.||In diagnostic study, were details of test administration and replication sufficient?||N/A|
|7.||Were outcomes clearly defined and the measurements valid and reliable?||Yes|
|7.1.||Were primary and secondary endpoints described and relevant to the question?||Yes|
|7.2.||Were nutrition measures appropriate to question and outcomes of concern?||Yes|
|7.3.||Was the period of follow-up long enough for important outcome(s) to occur?||Yes|
|7.4.||Were the observations and measurements based on standard, valid, and reliable data collection instruments/tests/procedures?||Yes|
|7.5.||Was the measurement of effect at an appropriate level of precision?||Yes|
|7.6.||Were other factors accounted for (measured) that could affect outcomes?||No|
|7.7.||Were the measurements conducted consistently across groups?||Yes|
|8.||Was the statistical analysis appropriate for the study design and type of outcome indicators?||No|
|8.1.||Were statistical analyses adequately described and the results reported appropriately?||Yes|
|8.2.||Were correct statistical tests used and assumptions of test not violated?||Yes|
|8.3.||Were statistics reported with levels of significance and/or confidence intervals?||Yes|
|8.4.||Was "intent to treat" analysis of outcomes done (and as appropriate, was there an analysis of outcomes for those maximally exposed or a dose-response analysis)?||No|
|8.5.||Were adequate adjustments made for effects of confounding factors that might have affected the outcomes (e.g., multivariate analyses)?||No|
|8.6.||Was clinical significance as well as statistical significance reported?||Yes|
|8.7.||If negative findings, was a power calculation reported to address type 2 error?||N/A|
|9.||Are conclusions supported by results with biases and limitations taken into consideration?||Yes|
|9.1.||Is there a discussion of findings?||Yes|
|9.2.||Are biases and study limitations identified and discussed?||No|
|10.||Is bias due to study's funding or sponsorship unlikely?||No|
|10.1.||Were sources of funding and investigators' affiliations described?||Yes|
|10.2.||Was the study free from apparent conflict of interest?||Yes|