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 present the experience with the laparoscopic adjustable gastric banding (LAGB) since 1994 in a large group of patients.

Inclusion Criteria:

Between 1994 and 1999, all morbidly obese patients who met the following criteria were selected for LAGB
- Body weight greater than 200kg
- Mild depression.
After 1999, patients with the following criteria were included
- BMI greater than 50kg per m²
- Sweet-eater symptoms for laparoscopic Roux-en-Y gastric bypass (LRYGBP)
- BMI greater than 60kg per m² for laparoscopic biliopancreatic diversion with duodenal switch (LBPD-DS).

Exclusion Criteria:

Patients with insufficient weight loss (less than 10kg in six months) were excluded from LAGB placement
Patients with severe psychiatric disease (not including mild depression) were excluded from surgery.

Description of Study Protocol:

Recruitment: From May 1994 to June 2002, all patients (984) underwent LAGB at four institutions
Design: 984 consecutive patients who underwent LAGB at four institutions were evaluated. Retrogastric placement was performed in 577 patients up to June 1998. Thereafter, the pars flaccida to perigastric (two-step technique) was used in the following 407 patients.
Blinding used: Not discussed
Intervention: Patients underwent LAGB. The first two patients received SAGB; patients 3 to 881 received Lap-Band; 30 heliogast bands were also used.
Statistical analysis: Not discussed.

Data Collection Summary:

Timing of measurements: May 1994 to June 2002
Dependent variables: Patient health status and weight control
Independent variables: Type of surgery for weight loss: Laparoscopic adjustable gastric banding (LAGB) or Roux-en-Y gastric bypass (RYGBP).

Description of Actual Data Sample:

Initial N: 984 patients (82.5% female)
Attrition (final N): 984
Average age: 37.9 years
Ethnicity: Not discussed
Other relevant demographics: None
Anthropometrics:
- Initial body weight: 127.9± 23.9kg SD
- Average percentage excess weight (% EW) 208±32%.
Average BMI: 46.4±7.2kg per m²
Location: Germany.

Summary of Results:

There were no deaths and no conversions to open surgery
All complications were seen in first 100 procedures
Early complications were one gastric perforation after previous hiatal surgery and one gastric slippage
Late complications included 17 slippages requiring re-interventions
Mean excess weight loss was 59.3% after eight years if patients with band loss are excluded (five patients of first 100 had band removed)
BMI dropped from 46.8 to 32.3kg per m²
Quality of life indices were still improved in 82% of the first 100 patients
Most co-morbid conditions resolved by one year after surgery. Notably 92% of patients with diabetes no longer required medications.
Major complications requiring re-operations developed in 3.9%
Reflux symptoms dropped from 68% to 4%.

Author Conclusion:

LAGB is safe, with a lower complication rate than other bariatric operations
The LAGB seems to be the basic bariatric procedure, which can be switched laparoscopically to combined bariatric procedures if treatment fails
On the basis of eight years long-term follow-up, LAGB is an effective procedure.

Funding Source:

University/Hospital:

University of Giessen, U of Wuerzburg, Nordwest Hospital, Chirurgische Klinik

Reviewer Comments:

No statistical data was discussed.

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?		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.)	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?	Yes
	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?	Yes
	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.)	Yes
	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?		No
	8.1.	Were statistical analyses adequately described and the results reported appropriately?	No
	8.2.	Were correct statistical tests used and assumptions of test not violated?	???
	8.3.	Were statistics reported with levels of significance and/or confidence intervals?	???
	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)?	???
	8.6.	Was clinical significance as well as statistical significance reported?	???
	8.7.	If negative findings, was a power calculation reported to address type 2 error?	???
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?	Yes
10.	Is bias due to study's funding or sponsorship unlikely?		???
	10.1.	Were sources of funding and investigators' affiliations described?	No
	10.2.	Was the study free from apparent conflict of interest?	???