Laparoscopic Single Anastomosis Duodeno-ileal Bypass versus One Anastomosis Gastric Bypass as Revisional Procedures after Sleeve Gastrectomy: Meta-analysis and Systematic Review

doi:10.21203/rs.3.rs-4850487/v1

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Laparoscopic Single Anastomosis Duodeno-ileal Bypass versus One Anastomosis Gastric Bypass as Revisional Procedures after Sleeve Gastrectomy: Meta-analysis and Systematic Review

https://doi.org/10.21203/rs.3.rs-4850487/v1

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Introduction: It has been observed that 5-8% of primary bariatric procedures result in treatment failure, necessitating the need for revisional surgery. In this systematic review and meta-analysis, we aim to compare the effectiveness of single anastomosis duodeno-ileal bypass (SADI) and one anastomosis gastric bypass (OAGB) in addressing weight regain following sleeve gastrectomy.

Methods: We systematically searched PubMed, Scopus, Web of Science and Cochrane Central Register of Controlled Trials databases. Studies were considered eligible if they compared SADI with OAGB as revisional surgeries following sleeve gastrectomy.

Results: Our search strategy yielded 4 articles with a total of 309 patients. Regarding weight loss at 1 year of follow-up, SADI was favorable based on excess weight loss percentage (EWL%) and total weight loss percentage (TWL%). At 2 years of follow-up, EWL% did not show a statistically significant difference between the two operations although TWL% was higher in SADI group. Regarding postoperative bile reflux, the OAGB group had a significantly higher incidence of biliary reflux (OR 0.15; 95% CI 0.04 to 0.53; P = 0.003). Patients enrolled in SADI did not develop anastomotic ulcers according to the 4 studies included in the analysis. In contrast, 7 patients in the OAGB group did develop anastomotic ulcers, but the difference was not statistically significant (OR 0.23; 95% CI 0.05 to 1.10; P = 0.07).

Conclusion: SADI is a feasible procedure with a favorable outcome compared to OAGB as a revisional surgery following sleeve gastrectomy regarding weight loss at 1 year with a lower incidence of postoperative biliary reflux.

SADI carries better weight loss outcomes when compared to OAGB at 1 year of follow-up.
SADI and OAGB were found to have similar EWL% at 2 years of follow-up.
SADI yields a lower risk of bile reflux postoperatively in comparison to OAGB.

In the context of the escalating global prevalence of obesity, there has been a noticeable rise in the integration of bariatric surgery into clinical practice [1]. With an increasing number of primary interventions being conducted to address severe obesity and its accompanying complications, it has been observed that a proportion of 5–8% of these interventions result in treatment failure, necessitating the need for revisional surgery. The rationales behind pursuing revisional bariatric surgery are with the first being inadequate weight loss during the primary operation, as defined by a reduction of less than 25% in excess body weight, and the second being weight regain, which is characterized by a gain of more than 10 kg based on the nadir weight [2].

Sleeve gastrectomy (SG) was initially recognized as an initial bariatric intervention for individuals with severe obesity. Nevertheless, due to its perceived safety and efficacy in the short run, SG evolved into an independent bariatric procedure thereafter [3]. As indicated by the International Surgery of Obesity and Metabolic Disorders (IFSO), the year 2016 witnessed a notable surge in the frequency of SG, making it the most commonly executed bariatric surgery [4].

There exist diverse revisional procedures that can be pursued subsequent to sleeve gastrectomy (SG), including Roux-en-Y gastric bypass (RYGB) conversion, one anastomosis gastric bypass (OAGB) Single anastomosis duodeno-ileal bypass (SADI), and duodenal switch [5]. SADI and OAGB have been suggested as technically less complex but equally efficient substitutes for the Roux-en-Y procedures: namely the biliopancreatic diversion with duodenal switch (BPD-DS) and the Roux-en-Y Gastric bypass (RYGB), respectively [6, 7].

SADI was created in 2007 by Sanchez-Pernaute and is grounded on the biliopancreatic diversion with duodenal switch. This procedure aimed to simplify the technically challenging biliopancreatic diversion with duodenal switch by conducting only one anastomosis through a post pyloric duodeno-ileostomy. This leads to a lower anastomosis insufficiency and stricture rate. Additionally, this procedure reduces the operation time, resulting in a corresponding lower rate of anesthesia-related complications [8]. On the other hand, OAGB adheres to the same principle as the single anastomosis procedure, which was initially introduced by Rutledge in 2001 [6]. Unlike SADI, the prepyloric region is where the duodenal transection occurs, followed by a gastro-jejunal anastomosis. Our aim in this meta-analysis is to compare the effectiveness of SADI and OAGB in addressing weight regain following SG.

This systematic review and meta-analysis is registered in Prospero (#*******) (Blinded for review) and conducted in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines [9].

Study eligibility:

Studies were included in this meta-analysis if the inclusion criteria were fulfilled, studies were considered eligible if (1) SADI was compared to OAGB as a second-line procedure after sleeve gastrectomy, (2) Randomized controlled trials (RCTs) or observational cohorts, (3) patients were aged 18 and above. Studies were excluded if (1) SADI or OAGB were first-line procedures in the treatment of patients with obesity, (2) not published in English, (3) abstracts and case presentations, and (5) studies with overlapping populations.

Search strategy and data extraction:

We systematically searched PubMed, Scopus, and the Cochrane Central Register of Controlled Trials databases to conduct this systematic review and meta-analysis on 6 June 2024. The following search strategy was used to search the databases: (OAGB OR "one anastomosis gastric bypass" OR "single anastomosis gastric bypass" OR "omega loop gastric bypass" OR "mini gastric bypass") AND ("Single anastomosis duodeno-ileal bypass" OR "Single anastomosis duodenoileal bypass" OR "SADI-S" OR "SADI" OR "duodenal switch" OR "Single Anastomosis Duodeno-ileostomy" OR "duodenal switch"). Moreover, the reference lists of all meta-analyses, reviews and included studies were manually searched.

Three authors (*.*; *.*; *.*)(Blinded for review) independently extracted data according to the pre-defined search strategy and quality assessment methods. Disagreements between these three authors were resolved by consensus among four authors (*.*; *.*; *.*; *.*) (Blinded for review). Outcomes extracted included weight parameters after the revisional surgeries, such as percentage of excess weight loss (EWL%), and percentage of total weight loss (TWL%). Postoperative complications include bile reflux and anastomotic ulcers.

Quality assessment:

The most recent Cochrane Collaboration’s tool (RoB2) was utilized to assess the risk of bias of the included RCTs [10]. Each study was assessed in five domains: randomization process, deviations from intended interventions, missing outcome data, measurement of the outcome, and selection of the reported result. The studies were given a score of “high risk”, “low risk”, or “unclear risk” in each domain which resulted in an overall risk of bias judgment.

Observational studies were assessed for risk of bias using the Risk Of Bias In Non-randomized Studies - of Interventions (ROBINS-I) tool [11]. The seven bias domains assessed in ROBINS-I included: bias due to confounding factors, selection of participants, classification of interventions, deviations from intended interventions, missing data, measurement of outcomes and selection of the reported results. An overall risk of bias judgment was reached based on the seven assessed domains.

Statistical analysis:

Binary outcomes were compared using odds ratio and 95% confidence intervals using the random-effects model (Mantel-Haenszel statistical method). Mean difference and 95% confidence intervals with the random effect models were implemented to assess continuous outcomes. Endpoints with a P value of < 0.05 were considered statistically significant. Outcomes were considered to have low heterogeneity if P > 0.10 and I² < 25%. Review manager version 8.1.1 and R version 4.4.1 were used to assess the outcomes included in this review.

Our search strategy yielded 277 potential articles, as presented in (Fig. 1). After removing duplicate records and studies not meeting the inclusion criteria based on title and abstract, 14 remained and were thoroughly assessed for inclusion. A total of 4 articles were included in this meta-analysis [12–15], with a total of 309 patients from Qatar, Germany, Italy and Egypt. 151 patients were assigned to SADI group, on the other hand 158 patients were assigned to OAGB group. Baseline characteristics are presented in (Table 1) of this study.

Table 1

SADI/OAGB baseline characteristics.

Author,

year

Journal

Country

Patients

Study Design

Females,

n (%)

Age

(years)

BMI*

Operative time (min)*

Follow-up

(months)

El Shayeb et al, 2023 [12]

Ain Shams Journal of surgery

Egypt

25/52

RCT

43(86%)

34.24 ± 5.24/ 35.24 ± 5.83

44.32 ± 2.86 / 42.97 ± 3.35

154.6 ± 16.47/ 88 ± 18.03

Gallucci et al, 2024 [13]

Langenbeck's Archives of Surgery

Italy

42/42

Retrospective study

60(71.4%)

42.9 ± 9.7/ 41.2 ± 9.8

44.8 ± 8.2/ 43.8 ± 6.6

De la Cruz et al, 2020 [14]

Surgery for Obesity and Related Diseases

Germany

42/42

Retrospective study

59(70.2%)

45.1 ± 11.1/ 47.2 ± 10.8

42.8 ± 7.9/ 43.4 ± 9.2

138 ± 40/

123 ± 39

Bashah et al, 2020 [15]

Obesity Surgery

Qatar

42/49

Retrospective study

70(77%)

38 ± 9/

37.83 ± 9.36

43.7 ± 7.1/

43.6 ± 7.4

^{*: data represented as mean ± SD; n: number, NA: not applicable; min: minute; RCT: randomized controlled trial}

Figure 1. PRISMA flow diagram of study screening and selection.

Table 1

Baseline characteristics of SADI/OAGB.

Author,

year

Journal

Country

Patients

Study Design

Females,

n (%)

Age

(years)

BMI*

Operative time (min)*

Follow-up

(months)

El Shayeb et al, 2023 [12]

Ain Shams Journal of surgery

Egypt

25/52

RCT

43(86%)

34.24 ± 5.24/ 35.24 ± 5.83

44.32 ± 2.86 / 42.97 ± 3.35

154.6 ± 16.47/ 88 ± 18.03

Gallucci et al, 2024 [13]

Langenbeck's Archives of Surgery

Italy

42/42

Retrospective study

60(71.4%)

42.9 ± 9.7/ 41.2 ± 9.8

44.8 ± 8.2/ 43.8 ± 6.6

De la Cruz et al, 2020 [14]

Surgery for Obesity and Related Diseases

Germany

42/42

Retrospective study

59(70.2%)

45.1 ± 11.1/ 47.2 ± 10.8

42.8 ± 7.9/ 43.4 ± 9.2

138 ± 40/

123 ± 39

Bashah et al, 2020 [15]

Obesity Surgery

Qatar

42/49

Retrospective study

70(77%)

38 ± 9/

37.83 ± 9.36

43.7 ± 7.1/

43.6 ± 7.4

^{*: data represented as mean ± SD; n: number, NA: not applicable; min: minute; RCT: randomized controlled trial}

For weight loss parameters comparing both procedures at 1 year. The pooled analysis of the 4 included studies illustrated that SADI had better EWL% (95% CI 3.90-17.66; P < 0.01; I² = 61%; Fig. 2) and TWL% (95% CI 2.43–6.17; P < 0.01; I² = 0%; Fig. 3) when compared to OAGB.

In a 24-month period of follow up for weight loss, 3 studies were included in the analysis. EWL% did not show a statistically significant difference between both operations (95% CI -1.18-25.86; P = 0.07; I² = 90%; Fig. 4). In contrast TWL% was significantly higher in SADI compared to OAGB (95% CI0.96-9.68; P = 0.02; I² = 71%; Fig. 5).

For postoperative complications, the incidence of bile reflux was reported by 3 studies which showed that patients who underwent OAGB were more likely to develop bile reflux (OR 0.15; 95% CI 0.04–0.53; P = 0.003; I² = 0%; Fig. 6). Patients enrolled in SADI did not develop anastomotic ulcers according to the 4 studies included in the analysis. In contrast, 7 patients in OAGB group did develop anastomotic ulcers but the difference was not statistically significant (OR 0.23; 95% CI 0.05–1.10; P = 0.07; I² = 0%; Fig. 7; Supplementary file).

Figure 7. Incidence of anastomotic ulcers post-operatively (Supplementary file).

Regarding bias of the included studies (Fig. 8; Supplementary file) (Fig. 9; Supplementary file), all the studies carried some risk of bias, as the only included RCT by El Shayeb et al had some concerns and the retrospective study by Gallucci et al had a moderate risk of bias [12, 13], while the other included studies had serious risk [14, 15] with no studies reporting critical risk of bias.

Figure 8. RoB2 risk of bias assessment tool of the included RCT (Supplementary file).

Figure 9. ROBINS-I risk of bias assessment tool of the included observational studies (Supplementary file).

LSG is now established as an independent primary bariatric intervention [2], In the year 2014, the procedure most frequently carried out was LSG, which has continued to uphold its dominant position in the year 2016 [4].

The existing body of literature has delineated numerous reasons for undergoing revisional surgery following sleeve gastrectomy, with gastroesophageal reflux disease (GERD) and concerns related to weight being the predominant factors [16], in our metanalysis at 12 months follow-up the pooled analysis demonstrated higher EWL In the SADI Group furthermore the efficacy of SADI as revisional procedure after sleeve was illustrated by the latest meta-analysis [17] where patients that underwent SADI exhibited a substantial EWL of 47.73% (95% CI 37.86–57.61, I² = 95%) at 6 months and 59.39% (95% CI 51.18–67.61, I² = 95%) at 12 months.

SADI has been suggested as a simplified iteration of the DS by Sanchez-Pernaute and Torres [8, 18] and may serve as a viable alternative for additional weight reduction following sleeve gastrectomy particularly among individuals lacking notable symptoms of gastroesophageal reflux disease (GERD) [19], Regarding bile reflux our study showed that OAGB has higher rate of bile reflux compared SADI, The process by which bile refluxes into the gastric pouch can be readily understood. As a result of the surgical procedure, the gastrojejunal anastomosis remains constantly subjected to the flow of bile [20], The lack of a physical barrier, like a sphincter at the gastrojejunal junction, might lead to bile flowing into the gastric pouch, potentially causing gastritis and marginal ulcers [21].

Another important aspect of both surgeries is Nutritional Deficiencies. A highly pertinent facet within bariatric surgery pertains to the malabsorptive impact of the procedures and their consequent side effects. Among them, malnutrition and vitamin deficiencies prove to be most consequential. Notably, consensus has not been reached on recommended lengths of common, food, and bile loops, thus rendering the metabolic impacts of these procedures incomparable. When conducting a comparison of nutritional deficiencies subsequent to SADI, it has been widely documented that a greater proportion of deficiencies are observed, as per the studies conducted [22, 23], however all this can be explained by the length of the common channel as Salama et al [5],in his study showed a relatively limited incidence of severe malnutrition and hypoalbuminemia within the first year following surgery and this could be explained by the common channel length 250 to 300 cm in the sample.

This is the first metanalysis comparing SADI to OAGB as revisional surgery. The primary constraint of this review pertains to the absence of randomization in most of the studies that were referenced in addition to the limited number of patients involved but this can be explained by the rarity of the comparative studies between SADI and OAGB as SADI is a newly implemented procedure. In addition, the not all the included studies compared SADI and OAGB regarding comorbidities resolution and on a long-term basis. Thus, further RCTs comparing SADI and OAGB are needed to reach a definitive revisional surgery for weight regain following SG.

SADI and OAGB have displayed efficacy as procedures to tackle weight regain subsequent to SG However, SADI procedure has been shown to yield superior outcomes when employed as a revisional alternative for weight regain subsequent to SG in comparison to OAGB at 1 year of follow-up with OAGB carrying a higher risk of bile reflux post-operatively. Consequently, the provision of micronutrient supplementation throughout one's lifetime, coupled with prolonged medical attention, is deemed obligatory to avert the occurrence of enduring complications.

Conflict of interest:

The authors declare that they have no conflict of interest.

Statement of ethics and consent:

This meta-analysis paper is based on previously published studies and does not involve any direct participation of human or animal subjects and for this type of study formal consent is not required.

Funding:

There were no external sources of funding for this study.

Author Contribution

Y.A,I.A,M.A did run the search strategy and screened studies for inclusion. A.A and W.Y created figure 1 and table 1. Y.A and K.A did statistical analysis and generated forest plots. Y.A and H.E did risk of bias assessment. All the authors contributed in writing, revising and editing of the manuscript text.

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No competing interests reported.

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You are reading this latest preprint version

Laparoscopic Single Anastomosis Duodeno-ileal Bypass versus One Anastomosis Gastric Bypass as Revisional Procedures after Sleeve Gastrectomy: Meta-analysis and Systematic Review

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Version 1

Abstract

Figures

Key Points

Introduction

Methods

Study eligibility:

Search strategy and data extraction:

Quality assessment:

Statistical analysis:

Results

Discussion

Conclusion

Declarations

Conflict of interest:

Statement of ethics and consent:

Funding:

Author Contribution

References

Additional Declarations

Supplementary Files

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Version 1