The Roux-en-Y gastric bypass is effective in achieving established diabetes treatment targets, but durability is unknown.
To compare durability of Roux-en-Y gastric bypass added to intensive ...lifestyle and medical management in achieving diabetes control targets.
Observational follow-up of a randomized clinical trial at 4 sites in the United States and Taiwan, involving 120 participants who had a hemoglobin A1c (HbA1c) level of 8.0% or higher and a body mass index between 30.0 and 39.9 (enrolled between April 2008 and December 2011) were followed up for 5 years, ending in November 2016.
Lifestyle-intensive medical management intervention based on the Diabetes Prevention Program and LookAHEAD trials for 2 years, with and without (60 participants each) Roux-en-Y gastric bypass surgery followed by observation to year 5.
The American Diabetes Association composite triple end point of hemoglobin A1c less than 7.0%, low-density lipoprotein cholesterol less than 100 mg/dL, and systolic blood pressure less than 130 mm Hg at 5 years.
Of 120 participants who were initially randomized (mean age, 49 years SD, 8 years, 72 women 60%), 98 (82%) completed 5 years of follow-up. Baseline characteristics were similar between groups: mean (SD) body mass index 34.4 (3.2) for the lifestyle-medical management group and 34.9 (3.0) for the gastric bypass group and had hemoglobin A1c levels of 9.6% (1.2) and 9.6% (1.0), respectively. At 5 years, 13 participants (23%) in the gastric bypass group and 2 (4%) in the lifestyle-intensive medical management group had achieved the composite triple end point (difference, 19%; 95% CI, 4%-34%; P = .01). In the fifth year, 31 patients (55%) in the gastric bypass group vs 8 (14%) in the lifestyle-medical management group achieved an HbA1c level of less than 7.0% (difference, 41%; 95% CI, 19%-63%; P = .002). Gastric bypass had more serious adverse events than did the lifestyle-medical management intervention, 66 events vs 38 events, most frequently gastrointestinal events and surgical complications such as strictures, small bowel obstructions, and leaks. Gastric bypass had more parathyroid hormone elevation but no difference in B12 deficiency.
In extended follow-up of obese adults with type 2 diabetes randomized to adding gastric bypass compared with lifestyle and intensive medical management alone, there remained a significantly better composite triple end point in the surgical group at 5 years. However, because the effect size diminished over 5 years, further follow-up is needed to understand the durability of the improvement.
clinicaltrials.gov Identifier: NCT00641251.
Background
An increasing number of surgeons worldwide are now performing one anastomosis/mini gastric bypass (OAGB/MGB). Lack of a published consensus amongst experts may be hindering progress and ...affecting outcomes. This paper reports results from the first modified Delphi consensus building exercise on this procedure.
Methods
A committee of 16 recognised opinion-makers in bariatric surgery with special interest in OAGB/MGB was constituted. The committee invited 101 OAGB/MGB experts from 39 countries to vote on 55 statements in areas of controversy or variation associated with this procedure. An agreement amongst ≥ 70.0% of the experts was considered to indicate a consensus.
Results
A consensus was achieved for 48 of the 55 proposed statements after two rounds of voting. There was no consensus for seven statements. Remarkably, 100.0% of the experts felt that OAGB/MGB was an “acceptable mainstream surgical option” and 96.0% felt that it could no longer be regarded as a new or experimental procedure. Approximately 96.0 and 91.0% of the experts felt that OAGB/MGB did not increase the risk of gastric and oesophageal cancers, respectively. Approximately 94.0% of the experts felt that the construction of the gastric pouch should start in the horizontal portion of the lesser curvature. There was a consensus of 82, 84, and 85% for routinely supplementing iron, vitamin B
12
, and vitamin D, respectively.
Conclusion
OAGB/MGB experts achieved consensus on a number of aspects concerning this procedure but several areas of disagreements persist emphasising the need for more studies in the future.
Background
The most appropriate procedure for the treatment of super obesity (BMI
>
50 kg/m
2
) is unknown. We aimed to evaluate the safety, long-term (
>
5 years) weight loss, and adverse events ...between three commonly performed procedures, sleeve gastrectomy (SG), Roux-en-Y gastric bypass (RYGB), and one anastomosis gastric bypass (OAGB) in super-obese patients.
Methods
Between January 2002 and December 2015, 498 successive patients with super morbid obesity (BMI
>
50), who underwent SG or RYGB or OAGB, were recruited. Surgical outcome, weight loss, resolution of co-morbidities, and late complications were followed and compared between the 3 groups. All data derived from a prospective bariatric database and a retrospective analysis was conducted.
Results
The average patient age was 32.1 ± 10.4 years, with a mean body mass index (BMI) of 56.0 ± 6.7 kg/m
2
. Of them, 190 (38.9%) underwent SG, 62 (12.4%) RYGB, and 246 (49.4%) OAGB. There was no difference in basic characters between the 3 groups except SG had fewer diabetic patients. RYGB group had higher intraoperative blood loss, longer operating time, and hospital stay than the other 2 groups. RYGB had a higher 30-days post-operative major complication rate (4.8%) than SG (0.5%) and OAGB (0.8%). The follow-up rate at 1 and 5 years was 89.4% and 52.0%. At post-operative 5 years, OAGB had a higher total weight loss (40.8%) than SG (35.1%), but not RYGB (37.2%). SG had a lower remission rate in dyslipidemia comparing to OAGB and RYGB, but T2DM remission rate was no different between the groups. The overall revision rate is 5.4% (27/498) of the whole group, and SG had a lower revision rate (2.6%) than RYGB (8.1%) and OAGB (6.9%).
Conclusion
SG is an effective and durable primary bariatric procedure for the treatment of super obesity and metabolic disorders. OAGB had a similar operation risk to SG but resulted in a better weight loss than SG.
Graphical Abstract
Background
Laparoscopic sleeve gastrectomy (LSG) has been validated as a safe and effective treatment for morbid obesity. However, data of the long-term outcome remains lacking.
Methods
A total of ...1759 LSG was performed as primary bariatric procedure from 2005 to 2017 with mean age of 35.2 ± 10.3 years old (14–71), female 69.7%, mean body mass index (BMI) 37.9 ± 7.7 kg/m
2
, and mean waist width 113.7 ± 17.9 cm. All patients were evaluated and managed under a strict multidisciplinary team approach. A retrospective analysis of a prospective bariatric database and telephone interview of patients who defaulted clinic follow-up at 10 years was conducted.
Results
The mean operating time, intraoperative blood, and hospital stay of LSG were 121.5 ± 36.5 min, 40.8 ± 69.7 ml, and 2.8 ± 2.7 days, respectively. The 30-day postoperative major complication occurred in 25 (1.4%) patients. The major complication rate was 15% at first year and 0% at the last year. The follow-up rate at 1, 5 and 10 years were 89.3%, 52.1 and 64.4%. At postoperative 1, 5, and 10 years, the mean percentage of total weight loss (%TWL) and excess weight loss (EWL%) of LSG patients were 33.4, 28.3, and 26.6% and 92.2, 80.1, and 70.5%, respectively. The mean BMI became 27, 26.2, and 27.1 kg/m
2
at postoperative 1, 5, and 10 years. At follow-up, a total 69 patients needed surgical revision due to reflux disease (
n
= 45), weight regain (
n
= 19), persistent diabetes (
n
= 2), and chronic fistula (
n
= 3). The type of revision procedures were hiatal repair and gastropexy (
n
= 29), Roux-en Y gastric bypass (RYGB) (
n
= 23), and single anastomosis bypass (
n
= 17) with median time to revision 33 months (range 3–62). At 10 years, the overall revision rate was 21.5% (14/65) and 11(16.9%) of 65 patients were converted to RYGB. The other 54 patients remained at LSG anatomy, but 45% of them required proton pump inhibitor for reflux symptoms.
Conclusions
Our results showed that primary LSG is a durable primary bariatric procedure with sustained weight loss and a high resolution of comorbidities at 10 years, but about half the patients had de novo GERD. The need for conversion to RYGB was 16.9% at 10 years.
Background
Laparoscopic Roux-en-Y gastric bypass (LRYGB) is considered the gold standard for the treatment of morbid obesity but is technically challenging and results in significant perioperative ...complications. While laparoscopic mini-gastric bypass (LMGB) has been reported to be a simple and effective treatment for morbid obesity, controversy exists. Long-term follow-up data from a large number of patients comparing LMGB to LRYGB are lacking.
Methods
Between October 2001 and September 2010, 1,657 patients who received gastric bypass surgery (1,163 for LMGB and 494 for LRYGB) for their morbid obesity were recruited from our comprehensive obesity surgery center. Patients who received revision surgeries were excluded. Minimum follow-up was 1 year (mean 5.6 years, from 1 to 10 years). The operative time, estimated blood loss, length of hospital stay, and operative complications were assessed. Late complication, changes in body weight loss, BMI, quality of life, and comorbidities were determined at follow-up. Changes in quality of life were assessed using the Gastrointestinal Quality of Life Index.
Results
There was no difference in preoperative clinical parameters between the two groups. Surgical time was significantly longer for LRYGB (159.2 vs. 115.3 min for LMGB,
p
< 0.001). The major complication rate was borderline higher for LRYGB (3.2 vs. 1.8 %,
p
= 0.07). At 5 years after surgery, the mean BMI was lower in LMGB than LRYGB (27.7 vs. 29.2,
p
< 0.05) and LMGB also had a higher excess weight loss than LRYGB (72.9 vs. 60.1 %,
p
< 0.05). Postoperative gastrointestinal quality of life increased significantly after operation in both groups without any significant difference at 5 years. Obesity-related clinical parameters improved in both groups without significant difference, but LMGB had a lower hemoglobin level than LRYGB. Late revision rate was similar between LRYGB and LMGB (3.6 vs. 2.8 %,
p
= 0.385).
Conclusions
This study demonstrates that LMGBP can be regarded as a simpler and safer alternative to LRYGB with similar efficacy at a 10-year experience.
Background
Bariatric surgery may be beneficial in mildly obese patients with poorly controlled diabetes. The optimal procedure to achieve diabetes remission is unknown. In 2011, we published the ...short-term results of a pilot study designed to evaluate the efficacy of diabetic control and the role of duodenal exclusion in mildly obese diabetic patients undergoing laparoscopic sleeve gastrectomy (SG) vs. a laparoscopic single anastomosis (mini-) gastric bypass (SAGB). This study analyzes the 5-year results and evaluates the incretin effect.
Methods
A double-blind randomized trial included 60 participants with a hemoglobin A1c (HbA1c) level higher than 7.5 %, a body mass index (BMI) between 25 and 35 Kg/m
2
, a C-peptide level ≥1.0 ng/mL, and a diagnosis of type 2 diabetes mellitus (T2DM) for at least 6 months. A SAGB with duodenal exclusion or a SG without duodenal exclusion was performed.
Results
The 5-year results of the primary outcome were as an intention-to-treat analysis for HbA1c ≤6.5 % without glycemic therapy. Assessments of the incretin effect and β cell function were performed at baseline and between 36 and 60 months. The patients were randomly assigned to SAGB (
n
= 30) and SG (
n
= 30). At 60 months, 18 participants (60 %; 95 % confidence interval (CI), 42 to 78 %) in the SAGB group and nine participants (30 %; 95 % CI, 13 to 47 %) in the SG group achieved the primary end points (odds ratio (OR), 0.3; 95 % CI, 0.1 to 0.8 %). The participants assigned to the SAGB procedure had a similar percentage of weight loss as the SG patients (22.8 ± 5.9 vs. 20.1 ± 5.3 %;
p
> 0.05) but achieved a lower level of HbA1c (6.1 ± 0.7 vs. 7.1 ± 1.2 %;
p
< 0.05) than the SG patients. There was a significant increase in the incretin effect before and after surgery in both groups, but the SAGB group had a higher incretin effect than the SG group at 5 years.
Conclusions
In mildly obese patients with T2DM, SG is effective at improving glycemic control at 5 years, but SAGB was more likely to achieve better glycemic control than SG and had a higher incretin effect compared to SG.
Background
Bariatric surgery is an effective therapy for morbid obesity but may reduce calcium absorption and significantly decrease the bone mineral density. This study examined the prevalence of ...secondary hyperparathyroidism (SHPT) in obese subjects during follow-up after different bariatric surgeries. We investigated predictors of SHPT.
Methods
We enrolled 1470 obese subjects undergoing bariatric/metabolic surgery with at least 1-year follow-up, including 322 patients undergoing Roux-en-Y gastric bypass (RYGB), 695 undergoing single anastomosis (mini-) gastric bypass (SAGB), 93 undergoing laparoscopic adjustable gastric banding (LAGB), and 360 undergoing sleeve gastrectomy (SG). Five years of data were available for 215 patients. Patients were instructed to supplement their diet according to the guideline. Calcium, parathyroid hormone (PTH), and vitamin D levels were measured before surgery and at 1 and 5 years after surgery. SHPT was defined as PTH > 69 pg/mL.
Results
The overall prevalence of SHPT was high, 21.0% before surgery and was not different between patients with different bariatric procedures. Pre-operative PTH correlated with age, BMI, and vitamin D levels. Multi-variate analysis confirmed that vitamin D level was the only independent predictor of SHPT before surgery. The prevalence of SHPT increased to 35.4% at 1 year after surgery and 63.3% at 5 years after surgery. SAGB had the highest prevalence of SHPT (50.6%) followed by RYGB (33.2%), LAGB (25.8%), and SG (17.8%) at 1 year after surgery. At 5 years after surgery, SAGB still had the highest prevalence of SHPT (73.6%), followed by RYGB (56.6%), LAGB (38.5%), and SG (41.7%). Serum PTH at 1 year after surgery correlated with decreased BMI and weight loss. Multi-variate analysis confirmed that age, sex, calcium level, and bypass procedure were independent predictor of SHPT after surgery.
Conclusions
The prevalence of SHPT is high in morbidly obese patients before bariatric surgery which is related to vitamin D deficiency. The prevalence of SHPT increased continually along with the time after bariatric surgery, especially in patients receiving SAGB, followed by RYGB. The supplementation of vitamin D and calcium have to be higher in bypass procedure, especially in malabsorptive procedure.
Background
The YOMEGA study (Y-study) was a randomized trial comparing one anastomosis gastric bypass (OAGB) and Roux-en-Y gastric bypass (RYGB). Here, we aim to compare the Y-study and our pioneer ...trial from Taiwan (T-study).
Methods
Data from the Y-study and the T-study were collected and compared.
Results
The Y-study recruited 234 patients with a mean body mass index (BMI) of 43.9 and age of 43.5 years. The T-study recruited 80 patients with a similar mean BMI of 44.3 and mean age of 31.4 years. The studies had similar findings including (1)
OAGB is easier and possibly safer procedure than RYGB.
Both studies showed that OAGB had a shorter operation time than RYGB, but a lower surgical complication rate was only demonstrated in T-study. (2)
Both procedures have similar weight loss but OAGB features better glycemic control than RYGB.
Weight loss at 2 years after surgery was similar between two procedures, but OAGB reduced HbA1c to a greater degree than RYGB at 2 years in Y-study (− 2.3% vs. − 1.3%;
p
= 0.025). The resolution of the metabolic syndrome was 100% for both groups in the T-study. (3)
OAGB carried a higher risk of malnutrition.
OAGB had more malabsorptive problems with a lower hemoglobin level than RYGB at 2 years after surgery. Adverse malnutrition events occurred in nine (7.8%) OAGB patients in the Y-study. Four (3.4%) patients of OAGB received revision surgery in Y-study but none in T-study. (4)
Bile reflux was noted in OAGB patients but did not influence quality of life or revision rate.
Y-study found that bile in the gastric pouch was present in 16% of patients in the OAGB group versus none in the RYGB, but no inter-group difference in quality of life was detected. There was a trend for RYGB patients to experience more abdominal pain than OAGB.
Conclusions
Both studies showed that OAGB is a technically easier procedure and features better glycemic control than RYGB, but has a mal-absorptive effect. However, the bile reflux and abdominal pain controversies persisted.
Surgery is the most effective treatment of morbid obesity and leads to dramatic improvements in type 2 diabetes mellitus (T2DM). Gastrointestinal metabolic surgery has been proposed as a treatment ...option for T2DM. However, a grading system to categorize and predict the outcome of metabolic surgery is lacking. The study setting was a tertiary referral hospital (Taoyuan City, Taoyuan County, Taiwan).
We first evaluated 63 patients and identified 4 factors that predicted the success of T2DM remission after bariatric surgery in this cohort: body mass index, C-peptide level, T2DM duration, and patient age. We used these variables to construct the Diabetes Surgery Score, a multidimensional 10-point scale along which greater scores indicate a better chance of T2DM remission. We then validated the index in a prospective collected cohort of 176 patients, using remission of T2DM at 1 year after surgery as the outcome variable.
A total of 48 T2DM remissions occurred among the 63 patients and 115 remissions (65.3%) in the validation cohort. Patients with T2DM remission after surgery had a greater Diabetes Surgery Score than those without (8 ± 4 versus 4 ± 4, P < .05). Patients with a greater Diabetes Surgery Score also had a greater rate of success with T2DM remission (from 33% at score 0 to 100% at score 10); A 1-point increase in the Diabetes Surgery Score translated to an absolute 6.7% in the success rate.
The Diabetes Surgery Score is a simple multidimensional grading system that can predict the success of T2DM treatment using bariatric surgery among patients with inadequately controlled T2DM.
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