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Laparoscopic Roux-en-Y gastric bypass in the treatment of obesity: evidence based update through randomized clinical trials and meta-analyses

MORALES-MAZA, J.1; RODRÍGUEZ-QUINTERO, J. H.2; SÁNCHEZ-MORALES, G. E.1; GARCÍA-RAMOS, SÁNCHEZ E.1; ROMERO-VELEZ, G.2; AGUILAR-FRASCO, J. L.1; PIMIENTA-IBARRA, A. S.1; ALVAREZ-BAUTISTA, F. E.1; LEÓN, P.1; HERNÁNDEZ-ACEVEDO, J. D.1; DEL ANGEL-MILLAN, G.1; SIERRA, M.1

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Il Giornale di Chirurgia - Journal of the Italian Association of Hospital Surgeons: January 2020 - Volume 41 - Issue 1 - p 5-17
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Abstract

Introduction

Obesity and type 2 diabetes mellitus are chronic diseases that have dramatically increased the burden of healthcare in the last decades. They entail a critical problem, especially in low-income and middle-income countries, where their costs and complications frequently exceed the economic capacity of the system.

Bariatric surgery is currently considered an excellent therapeutic tool in selected patients with these problems, still there are several controversies that require to be further explored.

We performed a thorough review of the latest randomized clinical trials in bariatric surgery and discussed their results by topic.

Intensive medical treatment versus Roux-en-Y gastric bypass for the treatment of obesity

To date, multiple surgical techniques have been described, being Roux-en-Y gastric bypass (RYGB) the one that has been evaluated most thoroughly and through the strictest scientific standards.

To analyze this topic, we performed a meticulous review of the English literature using PubMed, Cochrane and Clinical Trials.gov databases employing the terms “bariatric surgery” and “Roux-en-Y gastric bypass”. We included all randomized controlled trials (RCT), systematic reviews (SR), and meta-analyses (MA) that compared the results of these two different strategies with no restrictions concerning the date of publication of the studies (Figure 1).

F1-1
Figure 1 - Flowchart. Performed search with MeSH terms: “:
bariatric surgery ” and “ Roux-en-Y gastric bypass ”.

Twenty-seven randomized clinical trials (RCT) (1-27) and ten systematic reviews with meta-analysis (28-37) have compared intensive medical treatment against surgical treatment for obesity. As widely known, the results show a trend that clearly favors bariatric surgery regarding increased total weight loss, and a significant improvement in metabolic parameters (Table 1). A Cochrane review was published in August 2014 that reported the results of bariatric surgery in the treatment of obesity (38). This review compared the results of several surgical techniques. It included 22 trials with 1798 participants. The Author concluded that surgical approaches result in greater improvement in weight loss outcomes compared with non-surgical interventions, regardless of the type of procedure performed.

T1-1
Table 1:
- SYSTEMATIC REVIEWS AND META-ANALYSES THAT REPORT THE RESULTS OF ROUX-EN-Y GASTRIC BYPASS WITH NON OPERATIVE APPROACHES IN THE TREATMENT OF OBESITY. ONLY THE RESULTS OF THE ROUX-EN-Y GASTRIC BYPASS TECHNIQUE ARE REPORTED FROM EACH STUDY. THE RESULTS OF THE OTHER TECHNIQUES ANALYZED ARE NOT DESCRIBED. ABBREVIATIONS: RYGBP: ROUX-EN-Y GASTRIC BYPASS.

Bariatric surgery in teenagers

Current evidence has shown that bariatric surgery for this group of patients achieves increased total weight loss and decreases cardiovascular complications on medium-term follow-up. However, ethical aspects, and the lack of long-term evidence still do not allow to make stronger recommendations in this setting (39).

The European Society of Endocrinology recommends considering bariatric surgery in teenagers only under special circumstances, emphasizing the benefits the intervention might have on their quality of life (40). Their clinical practice guideline bases this recommendation on prospective studies and mainly on the Teen Longitudinal Assessment of Bariatric Surgery (Teen-LABS) study and the Swedish study AMOS.

The first study (41) is a prospective cohort that included 242 patients under 19 years old (mean age 17 ± 1.6 years) with a mean body mass index (BMI) of 53 Kg/m2. RYGB and sleeve gastrectomy (SG) were performed in 161 and 67 patients, respectively and at three years, the average total weight loss in RYGB patients was 28% (95% CI 25-30, P <0.001) and 26% (95% CI 22-30, P < 0.001) in SG patients. Diabetes mellitus remission was accomplished in 95% of the patients (95% CI 85-100).

The second study (42) is a comparative matched cohort that included 81 adolescents followed during two years. BMI was 45.5 ± 6.1 (mean ± S.D.) at baseline and 30.2 (confidence interval 29.1-31.3) after 2 years (P<0.001) corresponding to a 32% weight loss and a 76% loss of excess BMI.

Two-thirds of adolescents undergoing surgery had a history of psychopathology. Nevertheless, the treatment was well tolerated and overall quality of life increased significantly. Adverse events were seen in 33% of patients, the majority of which were considered mild.

Also, a currently ongoing RCT including teenagers (between 14 and 16 years old), with BMI >40 kg/m2 or >35 kg/m2 and morbidities is aiming to evaluate the effects of adjustable gastric band (AGB) on the quality of life and weight loss. Results will be available by the end of 2020 according to the Authors (BASIC trial; Morbid obesity in children and adolescents; a prospective randomized trial of conservative treatment versus surgery ClinicalTrials.gov Identifier: NCT01172899).

There is a systematic review and meta-analysis based on retrospective studies, evidencing that bariatric procedures achieved substantial weight loss and improved comorbidities in teenager patients with obesity (43).

We found one Cochrane review that analyzed the effect of several surgical interventions for treating obesity in childhood and adolescence (44). This review included only one RCT (45) where the results of AGB against lifestyle modifications were compared in fifty patients. Although in this study the AGB led to greater body weight loss compared to a multi component lifestyle program, their results were limited by their small sample size, and larger trials are granted to ascertain the validity and reliability of this finding.

Surgical technique

A summary of the RYGB technique performed in our center is included: following a standard minimally invasive surgery protocol, 5 trocars (Four 12mm and two 5mm) are placed as shown (Figure 2). A gastric pouch is built using the lesser curvature of the stomach with a 45 mm stapler, which is initially fired horizontally 2-3 cm below the gastroesophageal junction. Then two to three additional staples are fired toward the angle of His and against a 32 Fr intragastric tube, completing the vertical transection. The biliopancreatic and alimentary limbs are assembled at 50 cm and 150 cm from the ligament of Treitz respectively. First, a latero-lateral antecolic and antegastric gastro-jejunostomy is constructed manually, followed by a latero-lateral jejuno-jejunostomy performed with a 45mm linear stapler and hand sewn closure of the enterotomy. All defects are closed using nonabsorbable sutures (46) (Figures 3, 4).

F2-1
Figure 2 - A) Trocar position in laparoscopic gastric bypass. B) Section of the stomach with linear cutting stapler 3-6 cm from the pylorus.
F3-1
Figure 3 - Laparoscopic Roux-en-Y gastric bypass technique. A) Dissection of lesser curvature of the stomach. B) Horizontal and longitudinal section of the stomach using the lineal cutting stapler, starting 3-6 cm from the pylorus. C) Gastrojejunostomy. D) Final construction of gastrojejunostomy. E) jejunojejunostomy conforming the Roux en Y. F) final configuration of gastric bypass.
F4-1
Figure 4 - Final construction of Roux en Y gastric bypass.

Laparoscopic versus open gastric bypass

A systemic review was published in 2011 (47). It involved patients that underwent RYGB by laparoscopic (n=214) and open (n=208) approach. The laparoscopic group had decreased length of hospital stay (LOS) (-1.11 days, P < 0.0001) but longer operative times (mean 28 minutes, P =0.006). Both procedures were considered safe, and there was no difference concerning postoperative complications (RR 0.84 95% CI 0.64-1.10, P =0.20) or weight related outcomes (Mean BMI change 1.0 kg.m2 95% CI 0.79-2.79, P =0.27) in both groups.

According to one of the studies included (48), an increased risk of reoperation was present in the laparoscopic group (RR 4.82 95% CI 1.29-17.98, P =0.02). They reported that six patients that underwent laparoscopic approach were reoperated within five weeks following the surgery, the reason was intestinal occlusion of the jejunum when crossing the mesocolic tunnel. This study was published in 2001 when the learning curve of laparoscopic bariatric surgery was still relatively beginning and the technique was still not fully standardized.

Antecolic versus retrocolic alimentary limb

In 2011 a RCT was performed aiming to define the most convenient technique between ascending the alimentary limb in an antecolic or retrocolic fashion in laparoscopic RYGB including 40 patients (49). No significant differences were found in operatory bleeding, beginning of oral intake, and length of hospital stay (LOS). However, the retrocolic group had longer operative times (mean 163.4 +-28.1 vs. 131.8 +-22.7 minutes, P < 0.05). Both techniques showed similar outcomes in the short-term; however, more evidence is needed to define long-term results as there are no more studies on this subject.

Closure of the mesenteric defect in laparoscopic RYGB

Two RCT exist in this subject. The first study (2014) included 105 patients subjected to laparoscopic RYGB (50). Fifty patients had the mesenteric defect closed and fifty-five did not. The follow-up time was three years. The closure of the mesenteric defect involved longer operative time, yet this was not statistically significant (mean 153 vs. 138 min P = 0.073). No other differences were detected between groups regarding outcomes. One patient in the no-closure group developed an internal hernia that required reoperation, but this finding did not reach statistical significance (P = 0.343).

On the other side, a multicentric trial that included 12 hospitals in Sweden was published in 2017 with a follow up of three years (51). The accumulated incidence of reoperation significantly decreased in the group that had the defect closed (HR 0.56 95%CI 0.41-0.76, P <.05). Closure of the mesenteric defect was associated with an increase in postoperative complications, mainly due to torsion and obstruction of the jejunojejunostomy (4.3% vs. 2.8%, HR 1.55 95% CI 1.01-2.39, P = 0.044).

Length of the alimentary limb

This topic is one of the main debates regarding the surgical technique of RYGB. In recent years, the most convenient length of the alimentary limb has been investigated aiming to achieve better long-term results according to the individual BMI of each patient (52).

Nine RCT have assessed whether the length of the alimentary limb affects the prognosis. The first study was published in 1992 (53). It was a prospective randomized trial with long-term follow-up that compared patients with an alimentary limb length of 150 cm (n=23) and 75cm (n=22) with a mean follow-up of 43 months (+-17). The mean weight loss was significantly higher in the 150 cm limb group at 24 and 36 months (P = 0.02).

In the 150 cm limb group, 19 of 22 patients presented at least 50% of weight loss compared with 11 of 22 patients in the short limb group.

A second study was published in 1998 (54). It was a prospective randomized study that included 60 patients who underwent open RYGB; Patients were divided into 4 groups defining the length of the alimentary limb according to the BMI of the patients and analyzed whether there were changes in resting energy expenditure through indirect calorimetry; (A) <51 kg/m2 - 150cm limb (n= 16); (B) BMI < 51 kg/m2 - 250cm limb (n= 16); (C) BMI >51 kg/m2 - 150cm limb (n= 18); or (D) BMI > 51 kg/m2 - 250 cm limb (n = 6). In this study, no statistically significant differences were found in the change in resting energy expenditure at 6 and 12 months after surgery. The Author concluded that basal metabolism was not associated with the length of the alimentary limb (P = 0.608).

A third study about this issue was published in 2002 (55). It was a prospective trial that compared two groups subjected to open RYGB with different alimentary limb length. The long limb group included patients with an alimentary limb of 150cm (n=34), 250cm (n=31) and the short limb group had an alimentary limb of 75 cm (n=35). No significant differences were found between the groups regarding mean weight loss at 36 months. Patients with a BMI >50 kg/m2 achieved greater weight loss when a longer limb (250 cm) was constructed. It was the first study that suggested that longer limbs may be beneficial in patients with higher BMI.

A study published in 2005 compared the outcomes following the construction of limbs with different lengths in patients with BMI <50 (56). They randomized their patients in two groups (alimentary limb length of 100 cm and 50 cm). A laparoscopic approach was performed, and patients were followed for 24 months. They did not find any significant differences between the groups regarding the effectiveness of the procedure; however, the long limb group presented a higher incidence of internal hernias.

In 2009, another prospective study was published with the objective of determining if the length of the alimentary limb in the open RYGB has an impact on weight loss with a 5-year follow-up (57). This study compared the results of three groups of patients stratified by limb lengths: group 1 (n= 112), 41- 61-cm limb; group 2 (n= 132) 130 -160-cm limb; and group 3 (n= 100), 115-250-cm limb. In the shorter limb cohort (group 1), the BMI change and weight change were always less than those in the long limb groups (P <.01 and .05). The BMI change and weight loss were not different between groups 2 and 3.

A study published in 2011 (58) compared the results to 3 years of follow-up using a “standard” alimentary limb (120-150 cm in length) and a “long” alimentary limb (170-200 cm in length). They found no difference in weight loss (IMC) or weight regain between groups at 1, 2 or 3 years follow-up (55.2 vs. 55; P = 0.933, 61.5 vs. 60.8 P = 0.831 and 61.1 vs.60 P = 0.932). With these results the Authors of this study suggest that longer-limb RYGB is not required in patients with BMI >50 kg/m2 for them to obtain long-term, sustained weight loss.

Another study published in 2014 (59) evaluated if the length is related to the percentage of weight loss one year after surgery. This study compared four groups of patients: A) biliopancreatic limb with 50 cm length and alimentary limb with 100 cm length; B) biliopancreatic limb with 50 cm length and alimentary limb with 150 cm length; C) biliopancreatic limb with 100 cm length and alimentary limb with 100 cm length; D) biliopancreatic limb with 100 cm length and alimentary limb with 150 cm length. Different lengths of the biliopancreatic and alimentary limbs did not affect the percentage of total weight loss (P = 0.66).

A RCT was published in 2015 (60), it compared perioperative outcomes of patients subjected to a proximal against a distal gastric bypass. They measured the length from the gastrojejunostomy in two different directions: anterograde and retrograde both 150 cm from the ileocecal valve (n=56 vs n=57, respectively). Patients in both groups had a BMI between 50 and 60 kg/m2. Mean operative time was 72 minutes (36-151 minutes) in the proximal group vs. 101 minutes (59-122 minutes) in the distal group (P =<0.001). Mean length of hospital stay (LOS) was two days in both groups. Authors concluded that in superobese patients, the distal bypass was associated with longer operative times and more severe complications without reaching a statistically significant difference.

In 2016 the last RCT on this subject was published (61). Standard gastric bypass (alimentary limb, 150 cm) and distal gastric bypass (common channel, 150 cm), both with a biliopancreatic limb of 50 cm and a gastric pouch of 25 mL were compared. The mean reduction in BMI was 17.8 (95% CI, 16.9-18.6) after standard gastric bypass and 17.2 (95% CI, 16.3-18.0) after distal gastric bypass, and the mean between-group difference was 0.6 (95% CI, -0.6 to 1.8; P = .32).

Recently, the first systematic review and meta-analysis based on 8 of these 9 RCTs about this issue was published (62). This meta-analysis suggested that short alimentary limbs weakened the efficacy of Roux-en-Y gastric bypass in terms of BMI loss (standard mean deviation, - 0.33 [95% CI - 0.60, - 0.05], P = 0.021) with 3 years of follow-up and % EWL (SMD, - 0.17 [95% CI, - 0.31, - 0.04], P = 0.013) with 2 years of follow-up. Compared with a standard alimentary limb (130-150 cm), a short alimentary limb (40-100 cm) may reduce the efficacy of the Roux-en-Y gastric bypass surgery, while a long alimentary limb (170-250 cm) did not significantly improve the effects in terms of BMI loss and % EWL.

The Author suggests that with further study on this subject it will be possible to shape the surgical technique and define the length of the alimentary limb in an individualized manner, achieving better long-term results.

Omentectomy in RYGB

It has been discussed that increased visceral fat is associated with several metabolic derangements. Four studies have addressed the hypothesis that omentectomy is associated with better outcomes after bariatric surgery.

In 2009 a RCT was conducted in Chile (63). Seventy patients that underwent RYGB were involved. Omentectomy was performed in 35 patients, and in the other 35 was not done. Patients were followed for two years. No differences were found between groups.

A second study was carried in Mexico in 2010 (46). Twenty-two patients with RYGB were randomized to omentectomy or standard RYGBP (n=11 vs. n=11, respectively). Omentectomy was associated with longer operative time (P <0.001). One of the patients with omentectomy presented a duodenal perforation during the procedure. Additionally, serum levels of interleukin-6, C reactive protein, tumor necrosis factor alpha, leptin, adiponectin, glucose, and lipid profile were evaluated, but no significant differences were found between the groups. The weakness of this study was the limited amount of patients included.

Another study of RYGB reported favorable outcomes when omentectomy was performed concerning glucose homeostasis and lipid profile (64). It included 15 patients with omentectomy and 11 patients without it. A significant decrease in fasting glucose levels (P <0.05) and very low-density lipoproteins (P =0.001) in the omentectomy group was observed. Despite the Author’s enthusiasm for their finding, there were no differences in weight loss between the groups.

A prospective study of patients undergoing SG, with or without omentectomy detected no significant differences between the groups (65).

The last study to date that assessed this subject was a prospective RCT with a five-year follow-up of RYGB patients (66). It compared 26 patients with omentectomy and 23 patients without omentectomy. Similarly to the other studies, they did not find any difference in weight loss and metabolic control.

Based on the evidence mentioned above, routine omentectomy is not currently recommended by the Authors of this review.

Handsewn versus stapled gastrojejunostomy

The single randomized study that has evaluated this topic in the long-term was published in Spain in 2015 (67). They included 248 patients with laparoscopic RYGB. The hand sutured group and the stapled group comprised 116 and 117 patients each and were followed over two years. Those with stapled anastomosis had a higher frequency of increased postoperative bleeding (4.2% vs. 0%, P =0.024) and surgical site infection (11.1% vs. 3.4% P =0.025). No differences were noticed when analyzing late complications, operative time, reoperation rate or lenght of hospital stay (LOS).

The performance of a hand sutured gastrojejunostomy may be more demanding technically and requires advanced laparoscopic skills; however, available data suggest that it has fewer complications in both short and long-term. Nevertheless, both techniques are considered safe for the patient. Surgeon expertise and preference must be considered when selecting anastomosis techniques.

Gastrojejunostomy diameter

One RCT appraised whether the diameter of the anastomosis affects the outcomes of RYGB (68). Two hundred patients were included. A 21 mm and a 25 mm circular stapler was employed in 100 patients of each group. Follow-up was two years. Both groups presented >80% of weight loss at follow up, without encountering any other statistically significant difference in the comparison between groups. This group recommends the use of a 25 mm circular stapler, due to the theoretical possibility of requiring endoscopic dilations when using the 21 mm stapler. However, no data exists in the current literature about this hypothesis.

Handsewn reinforcement of the staple line

There has always been controversy about the usefulness of reinforcing the staple line of anastomosis with a hand sewed running suture. A meta-analysis was published trying to answer this predicament (69). It included three RCT with a total of 180 patients (91 patients had their anastomosis reinforced, and 89 patients with no handsewn reinforcement). Regarding postoperative bleeding, there was no difference between groups (OR 0.32 IC 95% 0.03-3.1, P =0.33). The handsewn reinforced group presented a statistically significant reduction in operative time and anastomotic leaks (OR 0.1; 95% IC, 0.01, 0.78; P < 0.03).

The anesthetic block of transversus abdominis muscle in bariatric surgery

A MA evaluated the utility of transversus abdominis plane (TAP) block in bariatric surgery (70). It included three studies with a total of 205 patients with TAP block after bariatric surgery and were compared with placebo. A significant reduction in visual analog scale of pain by 0.9 was observed in the immediate postoperative period (95% IC -1.3, -0.5; P =0.001), and by 1.1 twelve hours after surgery (95% IC -1.6, -0.6; P =0.001). By 24 hours, the block decreased the use of morphine in 3.8 mg (95% IC -5.5, -2.2; P =0.001). Despite the favorable outcomes, more studies are required to evaluate this intervention in the specific context of RYGB, because the study included different bariatric procedures and subgroup analysis was not performed.

Hepatic retraction

In 2013, a study compared three different methods for hepatic retraction during laparoscopic RYGB (71). Three groups were analyzed according to the hepatic retractor employed (“Nathanson” hepatic retractor in 22 patients, a suspension band in 19 patients and a V-shaped hepatic retractor in 19 patients). The follow-up was done for one month. In the Nathanson retractor group, patients presented a significant increase in aspartate aminotransferase and alanine aminotransferase 18 hours following surgery. They concluded that “Nathanson” retractor use might associate with hepatic damage and suggested avoiding its use. No other differences were found between groups.

Use of fibrin glue on the anastomosis

To this date, only one study has evaluated the use of fibrin sealant to decrease anastomotic complications in RYGB (72). Two groups were compared; in the first (n=160) they applied fibrin sealant (TissucolR/TiseelR fibril sealant kit. Baxter Vienna Austria) to gastrojejunostomy and jejunojejunostomy, and in the second group no fibrin sealant was applied to the anastomoses (n=160). No significant differences were found about operative time, weight reduction, length of hospital stay (LOS) or the start of oral intake between the groups. The incidence of anastomotic leak was higher in the control group, but no statistical significance was reached (1 vs. 3 events). The control group displayed a higher rate of reoperation during the first 30 days (P =0.016). They concluded that more evidence is required to recommend the use of these products routinely.

Type of stapler for RYGB

A MA was published in 2012, it included nine studies, and only one was an RCT (73). A total of 9374 patients were included. The linear stapler group comprised 2946 patients and 6428 patients anastomosed using a circular stapler (Figure 5). The following outcomes were analyzed: anastomotic leak, stenosis, operative time, length of hospital stay (LOS), operative bleeding, surgical site infection rate, marginal ulcer rate, and weight loss at one-year follow-up. The use of circular stapler exhibited an increased rate of anastomosis stenosis. The use of linear stapler was associated with a decreased rate of surgical site infections, bleeding and operative time. No differences in the other evaluated outcomes were observed. They concluded that the use of linear staplers should be preferred.

F5-1
Figure 5 - Circular stapler gastrojejunostomy.

Hand assisted RYGB

Fourteen years ago a Swedish group published a RCT that evaluated the use of hand-assistance laparoscopic RYGB (74). Fifty patients were divided into two groups, a hand-assisted group (n=50) and a control group (n=50). Patients were followed for one year; the analysis showed comparable results in the use of opioids, technical complications, length of hospital stay (LOS), and weight loss. The hand-assisted group presented longer operative times (150 vs. 85 minutes, P <0.001), and one of such patients had to be reoperated secondary to anastomotic leak.

Use of surgical drains in bariatric surgery

To date, no RCT has evaluated the use of surgical drains in the specific context of bariatric surgery. Decisions regarding this subject are mainly influenced by the results of descriptive studies (75, 76). Their use might be considered depending on the surgeons consideration and previous experience but there is no clear evidence of its benefit.

Robotic versus laparoscopic RYGB

A systemic review on this subject was published in 2014 (77). Ten studies (only one RCT) with a total of 2557 patients were analyzed. No significant differences were found between patients that underwent robotic approach when compared to laparoscopy approach. There was a slight tendency that favors the laparoscopic approach in operative time but no significant difference was reached. Additionally, an economic analysis reported significantly higher costs in robotic surgery (mean 15,447 USD vs. 11, 956 USD) (78).

Conclusion

There is no doubt that bariatric surgery represents one of the most significant advances in medicine in the last century, and it has played a major role solving one of the principal public health problems nowadays worldwide. Approximately 150 RCT and 40 systematic reviews of literature with MA are available to date, giving credibility and scientific support to this surgical procedure, which is progressively becoming more common in medical practice.

Despite the tremendous amount of scientific advances in this area, several aspects remain to be defined, representing a promising field of opportunity in research for professionals interested in this area.

Disclosure

The Authors have no financial interest to declare in relation to the content of this article.

The Authors have no conflict of interest to disclose.

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Keywords:

Bariatric surgery; Obesity surgery; Roux-en-Y gastric bypass; Sleeve Gastrectomy

Copyright © 2020 The Authors. Published by Wolters Kluwer Health, Inc. All rights reserved.