|Year : 2023 | Volume
| Issue : 1 | Page : 3-12
Long- and very long-term unfavorable outcomes of the laparoscopic adjustable gastric band in the surgical approach of morbid obesity: A systematic review and meta-analysis
Eduardo Lemos de Souza Bastos1, Fábio Viegas2, Antonio Carlos Valezi3, João Caetano Dallegrave Marchesini4, Juliano Blanco Canavarros5, Antonio Silvinato6, Wanderley Marques Bernardo7
1 Department of Gastrointestinal Surgery, Marilia School of Medicine, Marília, Brazil
2 Rede D'or/São Luis, Rio de Janeiro, Brazil
3 Department of Surgery, State University of Londrina, Londrina, Brazil
4 Caetano Marchesini Clinic, Curitiba, Brazil
5 Gastro MT, Cuiabá, Brazil
6 Brazilian Medical Association Guideline Group, São Paulo, Brazil
7 University of São Paulo, São Paulo, Brazil
|Date of Submission||24-Jun-2022|
|Date of Acceptance||05-Sep-2022|
|Date of Web Publication||29-Sep-2022|
Dr. Eduardo Lemos de Souza Bastos
Department of Gastrointestinal Surgery, Marilia School of Medicine, Marília
Source of Support: None, Conflict of Interest: None
Aim: The aim is to assess the long- and very long-term rate of unfavorable outcomes associated with the laparoscopic adjustable gastric band (LAGB) in morbid obesity. Methods: The Preferred Reporting Items for Systematic Reviews and Meta-analyses statement was used in this systematic review. The search for evidence was performed in the MEDLINE (PubMed), EMBASE, LILACS, Clinical Trials, and Google Scholar databases from the inception to October 2021. The main eligibility criteria were obese adult undergoing LAGB, unfavorable outcomes, and a minimum follow-up of 4 years. Outcomes were aggregated using the Comprehensive Meta-Analysis software for noncomparative studies, and the quality of evidence was sorted. Heterogeneity was assumed when I2 >50%. Because of expected differences among retrieved studies and several uncontrolled variables, the random-effects model was used to perform a proportional meta-analysis. Results: Data on 23,916 unfavorable outcomes were extracted from 28 studies (N = 107,370 patients). The use of the LAGB may be related to a rate of around 30% for reoperation (95% confidence interval [CI] = 20.4%–41.4%), 18% for band removal (95% CI = 13.3%–24.5%), 12% for nonresponse (95% CI = 5.2%–23.8%), 8% for port/tube complications (95% CI = 5.1%–13.6%), 7% for slippage/prolapse (95% CI = 5.3%–9.7%), 6% for pouch enlargement (95% CI = 3.4%–9.9%), and 3% for erosion/migration (95% CI = 2.0%–4.3%) in the long- and very long-term follow-up. However, the quality of evidence was considered very low. Conclusion: Despite the very low quality of evidence, LAGB was associated with not negligible rates of unfavorable outcomes in long- and very long-term follow-up.
Keywords: Bariatric surgery, long-term care, morbid obesity, systematic review
|How to cite this article:|
Bastos EL, Viegas F, Valezi AC, Marchesini JC, Canavarros JB, Silvinato A, Bernardo WM. Long- and very long-term unfavorable outcomes of the laparoscopic adjustable gastric band in the surgical approach of morbid obesity: A systematic review and meta-analysis. J Bariatr Surg 2023;2:3-12
|How to cite this URL:|
Bastos EL, Viegas F, Valezi AC, Marchesini JC, Canavarros JB, Silvinato A, Bernardo WM. Long- and very long-term unfavorable outcomes of the laparoscopic adjustable gastric band in the surgical approach of morbid obesity: A systematic review and meta-analysis. J Bariatr Surg [serial online] 2023 [cited 2023 Mar 22];2:3-12. Available from: http://www.jbsonline.org/text.asp?2023/2/1/3/357463
| Introduction|| |
The gastric banding technique began in the early 1990s through the “Stoma Adjustable Silicone Gastric Band” by open approach. A few years later, the adjustable gastric band was placed laparoscopically, and, from then on, gained popularity among patients and surgeons, quickly becoming one of the most performed bariatric procedures worldwide., Technical simplicity, low postoperative morbidity and mortality, full reversibility, and the possibility of calibration (adjustments) according to the patient's adaptation/requirement may explain such acceptance at that time.
Notwithstanding, in the following years, poor mid- and long-term results and frequent reports of device-related complications were observed, leading to an exponential reduction in indications for this technique worldwide. Several data surveys have recorded this significant decline in gastric band indications, gradually replaced by gastric bypass initially, and sleeve gastrectomy more recently. In some countries, there is a strong tendency to give up the technique.,,
However, morbid obesity is a complex, multifactorial disease that cannot always be controlled by a single procedure, whatever it may be. Moreover, it is a lifelong disease where encouraging short-term results, regardless of the procedure, may not be enough to positively impact quality and life expectancy.
Despite the sharp drop in indications worldwide, the laparoscopic adjustable gastric band (LAGB) still retains some well-known advantages, such as allowing the reversal to the original anatomy with the simple removal of the device. This advantage pleases patients and surgeons worldwide and, together with the already known successful cases, keeps the band among the surgical treatment options for morbid obesity.
However, the perception of bariatric surgeons is that LAGB has not been an effective long-term procedure and is subject to an unacceptable rate of complications, which could justify its virtual disuse worldwide. Therefore, the current study aims to carry out a systematic review and meta-analysis to assess the long- and very long-term unfavorable outcomes of LAGB in the surgical approaching of morbid obesity.
| Methods|| |
This systematic review followed the dictates of the Preferred Reporting Items for Systematic reviews and Meta-Analyses.
The search for evidence if adverse events and/or treatment failure rates in the long- and very long-term could justify the banning of LAGB from the therapeutic arsenal of morbid obesity in adults was performed in the MEDLINE (PubMed), EMBASE, LILACS, Clinical Trials, and Google Scholar.
The search strategy was adapted to each database to achieve more sensitivity. The combined terms (Bariatrics OR Bariatric Surgery OR Bariatric Surgical Procedures OR Bariatric Surgical Procedures OR Bariatric Surgeries OR Stomach Stapling OR Gastric Bypass OR Gastroplasty OR Jejunoileal Bypass) AND Band * AND (Revision * OR Complication * OR Fail * OR Safety OR Adverse Effects OR Recurrence) were applied. The search period ranged from the inception of the databases to October 2021, without restrictions to languages.
Because all the analyses were performed based on previously published studies, no ethical approval or patient consent were required.
The eligibility criteria for inclusion of the studies were obese adults undergoing LAGB, outcomes with ineffectiveness and/or harm, any study design, full-text available, summary with data and minimum follow-up period of 4 years. Studies with intermediate outcomes were excluded from the study.
Two reviewers independently selected the titles identified by the search, extracted data and analyzed the results. Discrepancies were resolved by discussion and consensus.
Data extraction and risk of bias
Author's name and year of publication, population studied, intervention and comparison methods, absolute number of events for each outcome evaluated, and follow-up period were extracted from the included studies.
The measure used to express the lack of clinical efficacy and the complication rates varied according to the outcomes and were expressed as continuous variables (mean and standard deviation) or categorical variables (absolute number of events) with their respective intervals of confidence (95% confidence interval [CI]).
The risk of bias was estimated through Risk of Bias in Nonrandomized Studies of Interventions provided by Cochrane Methods Bias, and the quality of evidence was assessed and sorted by the The Grading of Recommendations Assessment, Development, and Evaluation (GRADE) terminology in very low, low, moderate, and high if meta-analysis was accomplished [Figure 1]. The GRADEpro (© 2021, McMaster University and Evidence Prime Inc.) software was used to accomplish this analysis.,
Outcomes analyzed in the included studies were overall rates of reoperation, slippage/prolapse, band removal, erosion/migration, gastric pouch dilation, port/tube complications, and lack of therapeutic response, defined as excess weight loss (EWL) <25%.
Studies with common outcomes were aggregated through meta-analysis using the Comprehensive Meta-Analysis software for noncomparative studies. Statistical heterogeneity between studies was assumed when I2 > 50%, highlighting the percentage of variability in effect estimates resulting from heterogeneity rather than sampling error., Because of the expected differences between the included studies and several uncontrolled variables, we used a random-effects model to perform a proportional meta-analysis on all selected outcomes.
| Results|| |
Study selection process
In the search for evidence, 4791 articles were initially retrieved, being selected by title and abstract 237 studies that meet the eligibility criteria, which were accessed for full-text analysis. After the manual exclusion of 209 studies, the remaining 28 were included for meta-analysis.,,,,,,,,,,,,,,,,,,,,,,,,,,,
The total population included was 107,370 patients who underwent LAGB and followed for at least 4 years to measure outcomes of reoperation, slippage/prolapse, band removal, erosion/migration, pouch enlargement, port/tube complications, and therapeutic nonresponse. A flow chart describing the selection process (inclusion and exclusion) is shown in [Figure 2], and the basic characteristics of the included studies are summarized in [Table 1]. The reasons for the 209 full-texts exclusions can also be found in [Figure 2].
|Figure 2: PRISMA flow diagram of literature search and selection. PRISMA: Preferred Reporting Items for Systematic Reviews and Meta-analyses|
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As shown in [Figure 3], the overall reoperation rate after LAGB was 29.9% (95% CI = 20.4%–41.1%), including a total of 14 studies with 7256 patients operated (I2 = 99%) (P = 0.000).
|Figure 3: Reoperation rate. Forest plot. Random effect: 29.9% (95% CI = 20.4% to 41.4%). CI: Confidence interval|
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Based on data from 18 studies with 847 cases, the overall slippage/prolapse rate of the LAGB was 7.2% (95% CI = 5.3%–9.7%) (I2 = 94%) (P = 0.000) [Figure 4].
|Figure 4: Slippage/prolapse. Forest plot. Random effect: 7.2% (95% CI = 5.3%–9.7%). CI: Confidence interval|
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As shown in [Figure 5], the overall rate of band removal was 18.2% (95% CI = 13.3%–24.5%), including a total of 17 studies with 12,433 patients (I2 = 98%) (P = 0.000).
|Figure 5: Band removal. Forest plot. Random effect: 18.2% (95% CI = 13.3%–24.5%). CI: Confidence interval|
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The overall band erosion/migration rate was 3.0% (95% CI = 2.0%–4.3%) using the LAGB, including a total of 22 studies with 657 cases (I2 = 93%) (P = 0.000) [Figure 6].
|Figure 6: Erosion/migration. Forest plot. Random effect: 3.0% (95% CI 2.0%–4.3%). CI: Confidence interval|
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The overall rate of gastric pouch enlargement was 5.9% (95% CI = 3.4%–9.9%) with the use of LAGB, including a total of nine studies with 1213 cases, as shown in [Figure 7] (I2 = 98%) (P = 0.000).
|Figure 7: Pouch enlargement. Forest plot. Random effect: 5.9% (95% CI = 3.4%–9.9%). CI: Confidence interval|
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The overall rate of port/tube complications was 8.4% (95% CI = 5.1%–13.6%) using the LAGB, including a total of 11 studies with 1181 cases (I2 = 98%) (P = 0.000) [Figure 8].
|Figure 8: Port/tube complications. Forest plot. Random effect: 8.4% (95% CI = 5.1%–13.6%). CI: Confidence interval|
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Lack of therapeutic response
The overall “nonresponse” rate (EWL <25%) was 11.6% (95% CI = 5.2%–23.8%) using LAGB, including a total of seven studies with 329 cases (I2 = 97%) (P = 0.000) [Figure 9].
|Figure 9: Nonresponse. Forest plot-Random effect: 11.6% (95% CI = 5.2%–23.8%). CI: Confidence interval|
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An analysis of the quality of evidence through the software GRADEpro in relation to the overall rate of occurrence of the outcomes included in the systematic review can be seen in [Table 2].
|Table 2: Analysis of the quality of evidence (The Grading of Recommendations Assessment, Development, and Evaluation) in relation to the overall rate of occurrence of the assessed outcomes|
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| Discussion|| |
LAGB is a fully reversible procedure since nothing is bypassed or withdrawn, and the simple removal of the device totally restores the original anatomy of the gastrointestinal tract. Technical simplicity and short operative time complement the main attractions of this technique. However, surgeons' perception of disappointed long-term outcomes, combined with not-negligible adverse effects and complications rate, compromised its initial popularity. Furthermore, the mechanism of action of LAGB is based mainly, but not exclusively, on the restrictive effect, and has currently been deferred in favor of bariatric procedures strongly associated with enterohormone-mediated metabolic effects.
Without detracting from the undeniable benefits for many patients who have already undergone LAGB, and those who still use it, this systematic review accurately evaluated the most common unfavorable gastric band results observed by bariatric surgeons over time. Based on the outcomes selected solely for this systematic review, the meta-analysis found an overall rate of approximately 30% for reoperation, 18% for band removal, 12% for nonresponse, 8% for port/tube complications, 7% for slippage/prolapse, 6% for pouch enlargement, and 3% for erosion/migration.
At first glance, the overall unfavorable outcome rates shown in our meta-analysis may appear lower than expected, and even inconsistent with surgical practice. In other words, it does not seem high enough to explain the widespread discouragement of surgeons from using LAGB. However, such percentages must be addressed with some caution, and two points must be highlighted. First, the rates compiled in the meta-analysis do not reflect the global occurrence of LAGB unfavorable events since the present systematic review included only studies with long- and very long-term data. If the short- and medium-term data were also aggregated, the global percentages would certainly increase a lot.
Furthermore, most of the addressed outcomes can be directly related to the device itself. Just for comparison purposes, it would be like observing such percentages of unfavorable outcomes related exclusively to stapling devices that are so widely used in bariatric surgery. Nevertheless, it should be noted that these device-related adverse outcomes might also be associated with the implantation technique and management. Mistakenly positioning and managing the device can contribute to possible unfavorable outcomes, such as pouch enlargement. Otherwise, proper placement and management can provide better results.
Regarding the outcomes included in this systematic review, it is advisable to be aware that they may be interconnected, and even overlapping. For instance, band removal is usually motivated by some other adverse event, such as band erosion. Unfortunately, the relationship between these events is often not clearly described in published studies.
Still, concerning the band removal outcome, a possible subsequent bariatric procedure was not the subject of this systematic review. More commonly, band removal comes along with conversion to sleeve or roux-en-Y gastric bypass, at either the same surgical time (one step) or a few weeks/months later (two-step)., This is a debate that remains open. Similarly, this systematic review did not seek to address which unfavorable outcome possibly led to reoperation.
The main limitation of our study was a very low certainty of evidence in the meta-analysis due to the high degree of heterogeneity between studies that met the inclusion criteria. Thus, meta-analysis inconsistency (I2) repeatedly remained above 90%, reflecting a high percentage of variation between studies due to heterogeneity between them. Neither high-quality comparative studies nor any randomized clinical trials met the inclusion criteria. Both factors contributed to the very low level of evidence in the analysis of pooled data for each outcome. This may reflect that the decline in the popularity of LAGB over the past few years appears to have been based more on clinical observation than on studies with high scientific evidence.
The meta-analysis was performed on significant sample size, exceeding 100,000 patients undergoing LAGB in the 28 studies that met the inclusion criteria, adding up to almost 24,000 occurrences of interest. Despite limitations arising from the type of studies retrieved, it is indisputably a robust sample size to support the conclusion.
Another strength of our study is that we only look at long- and very long-term outcomes, which is more appropriate when it comes to treating a chronic, relapsing disease such as obesity. The time elapsed from device implantation to observation of the unfavorable outcome ranged from 4 to 18 years (median 8.8 years). However, long- and very long-term studies are more likely to have significant losses to follow-up, resulting in a higher risk of bias inside the included studies.
Finally, to the best of our knowledge, this is the first systematic review with meta-analysis addressing the unfavorable, very long-term outcomes of LAGB in the surgical approach to morbid obesity.
| Conclusion|| |
This systematic review has shown a lack of high-quality studies with regard to long-and very long-term unfavorable outcomes of LAGB. Nonetheless, the meta-analysis resulting from the data extracted from these studies has shown not negligible unfavorable outcomes rates in the long- and very long-term follow-up associated with LAGB implantation.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Figure 1], [Figure 2], [Figure 3], [Figure 4], [Figure 5], [Figure 6], [Figure 7], [Figure 8], [Figure 9]
[Table 1], [Table 2]