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:

To study the effects, minor and major complications and outcomes of having a laparoscopic Swedish adjustable gastric banding (SAGB) surgery performed.

Inclusion Criteria:

BMI greater than 40kg per m²
Failure of competent, conservative treatment for two years
Less than 60 years of age
No significant intake of sweets or alcohol
No concurrent psychiatric illness.

Exclusion Criteria:

Surgery performed before or after the dates of June 1998 and December 2005
Did not meet the guidelines established by the Swiss Morbid Obesity Study Group
Failure to sign the written informed consent form
Failure to meet the "inclusion" criteria stated in the previous section.

Description of Study Protocol:

Recruitment: All patients that met the criteria for a SAGB surgical implantation procedure were enrolled in the prospective, clinical trial in Thun, Switzerland
Design: Five year, post-surgical, prospective, follow-up case series report
Blinding used: None attempted
Intervention: Swedish adjustable gastric band (SAGB) procedure was performed on 128 patients
Statistical analysis: Median and ranges were reported as well as mean ± SD information. Normal distribution of data was tested using a statistical test, Lillefors test. Student's T-test was used for statistical analysis, with P<0.05 taken as the level of significance.

Data Collection Summary:

Timing of measurements: Baseline data, three, six, nine and 12-month data were collected and thereafter, annual measurements were collected for five years
Dependent variables: Variable 1: Early and long-term complications; Variable 2: Pre-operation rate; Variable 3: Weight loss outcome of participants.
Independent variables: SAGB surgery.

Description of Actual Data Sample:

Initial N: 128 subjects (41 males, 87 females))
Attrition (final N): 94.5% patient follow-up
Age: Mean age was 40.4 years with a standard deviation of 5.3 years and a range of 19-68 years
Ethnicity: European adults from Switzerland
Other relevant demographics: Mean BMI was 44.5 with a standard deviation of 3.9 and a range of 34-60
Anthropometrics: Pre-operative mean weight was 126.7kg with a standard deviation of 7.8 and a range of 93-187kg. Mean excess weight was 67.6kg with a standard deviation of 6.8 and a range of 37-116.
Location: Thun, Switzerland.

Summary of Results:

Early and Late Complications (Minor and Major)

No one died because of the surgical procedures
The most frequent, early, minor complications (greater than 30 days) were wound infections or urinary tract infections. This occurred in only two or three patients, respectively.
The most frequent, early, major complications were one case of each of the following:
- Hematoma of the liver
- Bleeding from the spleen
- Gastric perforation
The minor, long-term complications (greater than 30 days) included one disconnection of the tube and one incisional hernia.
The major, long-term compliations included three band infections, two band migrations and seven band leakages
Overall, the minor and major early and late complications occurred at a low incidence rate (less than 11%).

Re-Operations

Three operations occurred because of minor complications. Each operation consisted of:
- One wound revision
- One port revision
- One incisional hernia repair
There were seven re-banding procedures, two band removals, two proximal gastric bypass procedures, and one splenectomy performed
Overall, the major complication rate was low with 15 of 128 patients (greater than 12%) experiencing the need for a re-do.

Weight Loss

The mean BMI after one, two and five years was 35.7, 33.7 and 31.8kg, respectively. All of these numbers were statistically significant.
The mean excess weight loss after one, two and five years was 33.3%, 45.5% and 57.4%, respectively. All of these numbers were also statistically significant.

Author Conclusion:

At five-years follow-up, laparoscopic SAGB proved to be a safe and effective surgical treatment for morbid obesity among the 128 patients in this Switzerland study
The surgical complications were few, minor and correctable.

Funding Source:

University/Hospital:

Spital Thun-Simmental AG (Switzerland)

Reviewer Comments:

This was a well-written, easy to understand study concerning 128 patients from Thun, Switzerland
The complications were described in detail and thoroughly accounted for
This article has many merits, but scored as neutral because of lack of study (comparison) groups and no mention of study limitation, biases, etc.
Overall, the study has merit and was forthcoming in revealing study details.

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?	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?		N/A
	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?	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?		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?		N/A
	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.)	No
	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?	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?	Yes
	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?		Yes
	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)?	N/A
	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?		Yes
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	Yes