Literature search results (Fig. 1)
Following the PRISMA guidelines of literature reviewing (Fig. 1), initial search identified 292 records. These records were screened and 235 were found clearly irrelevant and thus were excluded. Then the remaining 57 reports were sought for retrieval, and all were successfully retrieved and then assessed for eligibility. Then 46 reports were excluded following in-depth assessment because they were one of the following: Studies comparing between SLR arms other than specifically SGB vs OS/S (15 reports), one arm studies (13 reports), review articles (4 reports), how I/we do it articles (2 reports), studies in which the buttressing group wasn’t stratified to Seamguard buttressing and bovine pericardial strips buttressing (2 reports), studies comparing between arms not related to SLR (2 reports), or others (8 reports). Finally, 11 studies were included in this meta-analysis paper.
Study characteristics and baseline demographics (Table 1)
Included studies were either randomized controlled trials (4 studies) or nonrandomized cohort studies (7 studies). Baseline demographics of patients in the SGB and the OS/S arms in each study as number of patients (sample size), male to female ratio, mean age, and baseline BMI at bariatric surgery (BS); are summarized in Table 1 for randomized controlled trials (RCTs), and Table 2 for nonrandomized cohort studies.
Table 1
General characteristics and baseline demographics; randomized controlled trials
Study | Country | Low risk of bias scorea | Sample size | Gender (M/F) | Age (YO) | BMI at BS |
SGB | OS/S | SGB | OS/S | SGB | OS/S | SGB | OS/S |
Albanopoulos 2012 (15) | Greece | 7 / 7 | 48 | 42 | 19/29 | 18/24 | 37.6 | 37.9 | 46.08 | 47.4 |
Dapri 2010 (16) | Belgium | 4 / 7 | 25 | 25 | 11/14 | 17/8 | 39.4 | 41.3 | 49.7 | 47.7 |
Gentileschi 2012 (17) | Italy | 4 / 7 | 40 | 40 | 6/34 | 5/35 | 44.1 | 44.6 | 47 | 47.2 |
Prathanvanich 2015 (18) | USA | 2 / 7 | 16 | 14 | 3/13 | 2/12 | 47.88 | 42.29 | 49.61 | 47.14 |
a Cochrane collaboration tool was used to assess 7 elements (7 bias types) in each study. The low risk of bias score represents the number of elements (bias types) for which a study was judged to be low risk. SGB Seamguard buttressing, OS/S oversewing/suturing, M male, F female, YO year-old, BMI body mass index, USA United States of America. |
Table 2
General characteristics and baseline demographics; nonrandomized cohort studies
Study | Country | Study design | Quality scorea | Sample size | Gender (M/F) | Age (YO) | BMI at BS |
SGB | OS/S | SGB | OS/S | SGB | OS/S | SGB | OS/S |
Fort 2021 (19) | Spain | Retrospective | 9 / 9 | 100 | 100 | 37/63 | 42/58 | 46.3 | 45.4 | 47.9 | 46.1 |
Barreto 2015 (20) | USA | Retrospective | 8 / 9 | 860 | 373 | 254/606 | 104/373 | 46.1 | 46.2 | 49.6 | 50.5 |
D’Ugo 2014 (21) | Italy | Retrospective | 8 / 9 | 63 | 476 | 16/47 | 124/352 | 47.1 | 44.6 | 45 | 46 |
Contreras 2016 (22) | Chile | Prospective | 8 / 9 | 546 | 594 | NR | NR | NR | NR | NR | NR |
Polega 2015 (23) | USA | Retrospective | 7 / 9 | 42 | 475 | NR | NR | 48.8 | 45.7 | 49 | 50.2 |
VanderVennen 2015 (24) | USA | Retrospective | 7 / 9 | 817 | 445 | NR | NR | 48.7 | 45.7 | 47.2 | 48.7 |
Guerrier 2018 (25) | USA | Retrospective | 8 / 9 | 115 | 28 | NR | NR | NR | NR | NR | NR |
a Quality score of each study is measured according to the New-Ottawa Scale (NOS). SGB Seamguard buttressing, OS/S oversewing/suturing, M male, F female, YO year-old, BMI body mass index, BS bariatric surgery, USA United States of America, NA not applicable, NR not reported. |
Quality assessment results for the RCTs (Fig. 2)
Quality assessment results as judged by authors are available for all these studies (Fig. 2). Three studies were judged to have unclear risk of selection bias due to lack of information about random sequence generation and/or allocation concealment. The remaining study was judged to have low risk of selection bias. Regarding performance and detection bias, 3 studies were judged to have unclear risk of both performance bias and detection bias, while the remaining 1 study was judged to have low risk of both performance bias and detection bias. Regarding attrition bias and reporting bias, all studies were judged to have low risk of bias. For the other bias category, 3 studies were judged to have low risk of bias, while the remaining 1 study was judged to have unclear risk of bias.
Quality assessment results for the nonrandomized cohort studies (Table 2)
Out of seven studies, two had a score of 7 out of 9, four had a score of 8 out of 9, and 1 study had a score of 9 out of 9. Therefore, all studies were judged to be high quality studies per the Newcastle-Ottawa Scale (NOS).
Meta-analysis for mean operative time in minutes
Operative time was reported in 4 RCTs, 129 in the SGB group vs 121 in the OS/S group. In these studies, statistically significant decrease in operative time with SGB was observed (MD -13.92, 95% CI -19.14 – -8.70, p < 0.00001). I2 was 91% (p < 0.00001).
Operative time was reported in 2 nonrandomized cohort studies, 215 in the SGB group vs 128 in the OS/S group. In these studies, statistically insignificant decrease in operative time with SGB was observed (MD -15.00, 95% CI -32.74–2.74, p < 0.10). I2 was 76% (p = 0.04).
Meta-analysis for postoperative bleeding events (Fig. 3)
Postoperative bleeding events were reported in 2 RCTs, 88 in the SGB group vs 82 in the OS/S group. In these studies, statistically insignificant increase in postoperative bleeding events with SGB was observed (1.53, 95% CI 0.18–12.72, p = 0.69). I2 was 0% (p = 0.65) (Fig. 3A).
Postoperative bleeding events were reported in 6 nonrandomized cohort studies, 2443 in the SGB group vs 2391 in the OS/S group. In these studies, statistically insignificant increase in postoperative bleeding events with SGB was observed (1.14, 95% CI 0.58–2.23, p = 0.71). I2 was 16% (p = 0.31) (Fig. 3B).
Meta-analysis for postoperative leak events (Fig. 4)
Postoperative leak events were reported in 3 RCTs, 113 in the SGB group vs 107 in the OS/S group. In these studies, statistically insignificant increase in postoperative leak events with SGB was observed (OR 1.61, 95% CI 0.31–8.41, p = 0.57). I2 was 0% (p = 0.49) (Fig. 4A).
Postoperative leak events were reported in 7 nonrandomized cohort studies, 2543 in the SGB group vs 2491 in the OS/S group. In these studies, statistically insignificant decrease in postoperative leak events with SGB was observed (OR 0.82, 95% CI 0.40–1.66, p = 0.57). I2 was 0% (p = 0.93) (Fig. 4B).
Meta-analysis for mean LOS in days (Fig. 5)
Mean LOS (days) was reported in 2 RCTs, 73 in the SGB group vs 67 in the OS/S group. In these studies, statistically significant increase in mean LOS with SGB was observed (MD 0.86, 95% CI 0.37–1.34, p = 0.0006). I2 was 5% (p = 0.30) (Fig. 5A).
Mean LOS (days) was reported in 4 nonrandomized cohort studies, 1819 in the SGB group vs 1393 in the OS/S group. In these studies, statistically insignificant increase in LOS with SGB was observed with SGB (MD 0.22, 95% CI -0.00–0.45, p = 0.05). I2 was 90% (p < 0.00001) (Fig. 5B). Although statistically insignificant, the p value of 0.05 is exactly on the predetermined significance cutoff (p < 0.05). This with the statistically significant increase in LOS with SGB in randomized controlled trials, can allow us to consider the increase in LOS with SGB in nonrandomized cohort studies as statistically significant from the realistic point of view. Having said that, the heterogeneity observed among studies as observed by I2 and 95% prediction interval plot (Fig. 5C); limit generalizability of this finding. As shown in the plot (Fig. 5C), SGB will increase the LOS in most patients (the part of the plot right the the zero), but it will decrease the LOS in a minority of patients (part of the plot left to the zero).
Meta-analysis for readmission events (Fig. 6)
Readmission events were reported in 3 RCTs, 113 in the SGB group vs 107 in the OS/S group. In these studies, statistically insignificant increase in readmissions with SGB was observed (OR 2.08, 95% CI 0.36–11.89, p = 0.41). I2 was 14% (p = 0.31) (Fig. 6A).
Readmission events were reported in 4 nonrandomized cohort studies, 1834 in the SGB group vs 1321 in the OS/S group. In these studies, statistically insignificant increase in readmissions with SGB was observed (OR 1.38, 95% CI 0.77–2.47, p = 0.28). I2 was 0% (p = 0.82) (Fig. 6B).
Meta-analysis for reoperation events (Fig. 7)
Reoperation events were reported in 2 RCTs, 73 in the SGB group vs 67 in the OS/S group. In these studies, statistically insignificant increase in reoperations with SGB was observed (OR 2.89, 95% CI 0.29–28.56, p = 0.36). I2 was 0% (p = 0.95) (Fig. 7A).
Reoperation events were reported in 5 nonrandomized cohort studies, 1620 in the SGB group and 1642 in the OS/S group. In these studies, statistically significant decrease in reoperations with SGB was observed (OR 0.33, 95% CI 0.13–0.79, p = 0.01). I2 was 0% (p = 0.47) (Fig. 7B). Due to minimal heterogeneity among studies, and the fact that random effects model was used in analysis, the statistically significant decrease in reoperations is a generalizable finding. However, when compared to OS/S, number needed to treat (NNT) with SGB to prevent a single case of reoperation is 166 patients.