EAL

NCBS: Weight Loss and Weight Regain Expected After Procedure (2009)

Citation:

Study Design:

Class:

- Click here for explanation of classification scheme.

Quality Rating:

Research Purpose:

The purpose of this prospective randomized clinical trial was to assess the long-term outcomes (one and two years) and complications from laparoscopic adjustable gastric band (GB) and laparoscopic isolated sleeve gastrectomy (SG).

Inclusion Criteria:

Patient candidates for bariatric surgery who completed follow-up visits.

Exclusion Criteria:

None described.

Description of Study Protocol:

Recruitment

Procedures not described.

Design

A randomized clinical trial that randomized 80 bariatric surgery patients to a laparascopic gastric band (GB, N=40) or sleeve gastrectomy (SG, N=40).

Intervention

Patients seen during 2002 were randomly assigned to receive either the GB or SG procedures. At one and three years post-operatively, clinical visit data were used to assess post-surgical complications, weight loss, BMI loss and percent of excess weight lost (EWL). Questionnaires were used to assess hunger and cravings.

Statistical Analysis

Frequency and descriptive analyses were used to describe the characteristics and outcomes by group. Categorical variables were compared using chi square analyses and continuous variables were tested using Mann-Whitney tests. Significance was established at P<0.05.

Data Collection Summary:

Timing of Measurements

Follow-up measurements were taken at one and three years post-operatively. No further description was provided.

Dependent Variables

Measured at baseline (implied), one and three years follow-up:

Body weight (change since surgery)
Body mass index (BMI, change since surgery)
Excess weight loss (percent of baseline)
Feeling of hunger
Craving for sweets.

Independent Variables

Type of surgery (band vs. sleeve).

Description of Actual Data Sample:

Initial N

80 subjects
Seven males and 33 females (GB)
Nine males and 31 females (SG) (not significant).

Age

Median age of 36 years (20 years to 61 years) for GB
40 years (22 years to 65 years) for SG (not significant).

Other Relevant Demographics

Before surgery, six patients (15%) of the GB and eight patients (20%) of the SG group suffered from GERD, requiring daily medical therapy with proton pump inhibitors (PPI).

Anthropometrics

A median BMI of 37kg/m² (30kg/m² to 47kg/m² ) for GB
A median BMI of 39kg/m² (30kg/m² to 53kg/m² ) for SG (not significant).

Location

Saint-Pierre University Hospital, Brussels, Belgium.

Summary of Results:

	One-year Follow-up			Three-year follow-up
Weight Change	GB	SG	P	GB	SG	P
Median weight loss (kg)	14 (-5 to +38)	26 (0 to 46)	<0.0001	17 (0 to 40)	29.5 (1 to 48)	<0.0001
Median decrease of BMI (kg/m²)	15.5 (5 to 39)	25 (0 to 45)	<0.0001	18 (0 to 39)	27.5 (0 to 48)	0.0004
Median percentage EWL	41.4% (-11.8 to +130.5)	57.7% (0 to 125.5)	0.0004	48% (0 to 124.8)	66% (-3.1 to +152.4)	0.0025
Loss of feeling of hunger^a	42.5%	75%	0.003	2.9%	46.7%	<0.0001
Loss of craving for sweet eating^a	35%	50%	NS	2.9%	23.3%	NS

^aAbolished or diminished in the questionnaire.

Other Findings

The complications after GB were:

Shoulder pain
Frequent vomiting
Poor choice of alimentation
Gastric ulcer.

The complications after SG included:

Gastric pain
Frequent vomiting
Deficiency of minerals
Poor choice of alimentation.

Author Conclusion:

Sleeve gastrectomy provided significantly greater outcomes than gastric banding over one and three years of follow-up. Differences in weight loss and reductions in the sensations of hunger were attributed to to decreased production of ghrelin, a hormone produced in the gastric mucosa that stimulates the hunger center and improves the gastric emptying attributed to the sleeve intervention. However, there was a greater presence of complications from SG than in GB.

Funding Source:

University/Hospital:

Saint-Pierre University Hospital (Belgium)

Reviewer Comments:

If carried out appropriately, this is a sound piece of scientific data; however, there were minimal methodological details to assess recruitment, follow-up rates or accuracy of measures.

Quality Criteria Checklist: Primary Research
Relevance Questions
	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

Validity Questions
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?	???
2.	Was the selection of study subjects/patients free from bias?		???
	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?	???
	2.2.	Were criteria applied equally to all study groups?	???
	2.3.	Were health, demographics, and other characteristics of subjects described?	???
	2.4.	Were the subjects/patients a representative sample of the relevant population?	???
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)	Yes
	3.2.	Were distribution of disease status, prognostic factors, and other factors (e.g., demographics) similar across study groups at baseline?	Yes
	3.3.	Were concurrent controls or comparisons used? (Concurrent preferred over historical control or comparison groups.)	Yes
	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?	N/A
	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?		No
	4.1.	Were follow-up methods described and the same for all groups?	???
	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%.)	No
	4.3.	Were all enrolled subjects/patients (in the original sample) accounted for?	???
	4.4.	Were reasons for withdrawals similar across groups?	No
	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?		???
	5.1.	In intervention study, were subjects, clinicians/practitioners, and investigators blinded to treatment group, as appropriate?	???
	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.)	???
	5.3.	In cohort study or cross-sectional study, were measurements of outcomes and risk factors blinded?	N/A
	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?	Yes
	6.2.	In observational study, were interventions, study settings, and clinicians/provider described?	N/A
	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?	N/A
	6.6.	Were extra or unplanned treatments described?	N/A
	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?		No
	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?	???
	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?	???
	7.5.	Was the measurement of effect at an appropriate level of precision?	???
	7.6.	Were other factors accounted for (measured) that could affect outcomes?	No
	7.7.	Were the measurements conducted consistently across groups?	???
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?	No
	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)?	???
	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?	No
	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?		???
	10.1.	Were sources of funding and investigators' affiliations described?	???
	10.2.	Was the study free from apparent conflict of interest?	???