| Abstract |
The World Health Organization (WHO) estimates that approximately 2.3 billion adults worldwide are overweight and more than 700 million are obese.
Obesity is associated with increased mortality and with high risk of developing other devastating diseases such as diabetes, hypertension, obstructive sleep apnea etc and has become a worldwide leading health concern.
Bariatric surgery is the only effective treatment for severe obesity, offering long term weight loss and remission or improvement of obesity co-morbidities.
However, bariatric surgery should be safe and effective. This will require surgeons with high level of education, experience in both laparoscopic and gastrointestinal surgery and committed to long term follow-up of their morbidly obese patients. Additionally, institutions able to undertake the management of morbidly obese patients should have the necessary equipment and ancillary services.
Since the field of bariatric surgery continues to grow and the implicit goal of ensuring that surgeons and hospitals have met minimum criteria to safely perform bariatric surgery, the “International Federation for the Surgery of Obesity and Metabolic disorders (IFSO) created guidelines for the safe and effective bariatric patients management. Institutions and surgeons fulfilling IFSO requirements and able to prove that they are offering safe and effective management of patients suffering from metabolic disorders, may receive the designation as Centers of Excellence (COE) in bariatric and metabolic surgery.
The European Accreditation Council for Bariatric and Metabolic surgery (EAC-BS), is an organization formed to examine surgeon’s credentials, institutional facilities, services and surgeries outcome to ensure outstanding management of bariatric and metabolic patients in close collaboration with IFSO-European Chapter (IFSO-EC). The surgeon and institution’s requirements set by IFSO in Porto 2007 are used for evaluation. Belgium, Czech Republic, Egypt, France, Germany, Italy, Portugal, Ireland, Romania, Russia, Spain, Switzerland, Turkey, Ukraine, South Africa, United Arab Emirates, Saudi Arabia, Iran, Bahrain, Slovenia, United Kingdom, The Netherland, Greece and India are countries with surgeons and institutions participating in the COE program. Pre and post-operative data from all patients are entered anonymously into an international bariatric registry (IBAR) in order to enable the evaluation of each surgeon and institution.
In 2010, a Centre of Excellence Program was initiated in the area of Europe, Middle East and Africa by the relevant IFSO Chapter. Major aim of the COE concept was to describe the requirement for improvement of the management offered to morbidly obese patients. Surgeon’s experience, volume of patients treated per year, institutional equipment, facilities and services are of the outmost importance for safe and effective treatment of the morbidly obese patients.
Another highly important aspect of the project was the collection, processing and study of accumulated patients’ data from many institutions of the region and the extraction of conclusions concerning unknown or debated aspects of the bariatric procedures.
In recent years, Sleeve Gastrectomy emerged as a commonly used bariatric operation. It is therefore, very interesting to be compared with the old standard procedure for treatment of severe obesity, the Roux-en-Y Gastric Bypass, particularly as far as morbidity, mortality, weight-loss and outcome of obesity co-morbidities are concerned.
This study reviewed retrospectively the prospectively reported data from participating institutions at IFSO’s COE program and compares the two most commonly used bariatric operations, Roux-en-Y gastric bypass (GBP) and sleeve gastrectomy (SG).
PATIENTS AND METHODS
Volume of data
Since its inception, the volume of data in the IBAR has expanded significantly. The registry was formally launched in 1st January 2010 and since that time more than 130 bariatric surgeons from 24 Countries have been entering their operated patients with metabolic disorders. The total number of procedures entered in the IBAR reached 33062 by 31st December 2015. Out of those, 6413 SGs and 10,622 RYGBPs performed as primary procedures by December 31, 2014, with at least 12-months follow-up, were retrospectively analyzed. Sleeve gastrectomy originally planned as part of a two stages procedure have been excluded from this study.
Parameters studied
Patients’ demographic characteristics (age, sex), body mass index (BMI) and obesity related main co-morbidities such as hypertension (HPT), type 2 diabetes mellitus (T2DM), dyslipidemia, osteoarticular disease and sleep apnea syndrome, were recorded before surgery. Operative variables such as open or laparoscopic approach, intra-operative complications and hospitalization time were also recorded. Outcome variables included early (≤30 days) mortality, re-admission and re-operation rates as well as late (>30 days) complication, re-admission and re-operation rates and mortality from any cause. Excess weight loss (%EWL) and the outcome of obesity co-morbidities were also recorded and analyzed.
Statistical analysis and presentation of results
Values are expressed as median and range or number (n) and percentage (%). The Mann-Whitney U-test was used for comparisons between groups (GBP vs SG). Frequency analysis was performed by x2 test, with Yate’s correction. All p values are two tailed. A p-value less than 0.05 was considered as statistically significant.
RESULTS
Annual procedures
There were steadily increasing numbers of patients underwent sleeve gastrectomy from 2010 to 2015, whereas the number of patients underwent gastric bypass has been increasing from the year 2010 across the year 2012, followed by diminishing numbers up to the end of 2015.
Male/female ratio
Statistically significant (p<0.0001) more male patients underwent sleeve gastrectomy in comparison to gastric bypass. Most patients in both procedures were female: 69.50% of those that underwent GBP and 76.10% of those that underwent SG.
Age and BMI distribution
The majority of patients in both groups were between 40 and 60 years old, followed by the 20-40 age group. Sleeve Gastrectomy patients were younger (40.78% < 40 years vs 35.49% for GBP) and significantly heavier (median BMI 43.43, range: 26.95-78.6 kg/m2) comparing to GBP patients (median BMI 42.46 kg/m2, range: 26.28-75.5 kg/m2). Additionally in the SG group there were more super obese patients (19.35% vs 14.11%).
Co-morbidities prevalence
Information about the main co-morbidities was available on all patients in both groups. The prevalence of hypertension, T2DM, and dyslipidemia were statistically higher among GBP patients (p< 0.0001), while osteoarticular disease was more frequent among SG patients (p< 0.0001). The incidence of sleep apnea syndrome was not statistically different among patients in both groups.
Operative approach
Laparoscopic approach was used in the vast majority of patients for both procedures. (6,340 – 98.86 % in SG and 10,573 – 99.54 % for GBP). However, in SG group the open approach was chosen in a small but significantly higher number of patients than in GBP group (p< 0.0001). Conversion to open approach was uncommon (0.17 % for SG and 0.1 % for GBP – NS).
Intra-operative complications
The overall per-operative complications rate for SG group was 1.21 % vs 1.03% for GBP group – NS. No death occurred during both procedures (table 3).
Hospitalization
Discharge from hospital during the same or first post-operative day was reported in 68,40 % of patients with GBP and for 40,10 % of patients with SG, indicating significantly faster discharge for patients following GBP (p<0.0001). The median length of hospital stay was also statistically significantly shorter (p=0.001) in the GBP group [median: 2 days (range: 0-45 days) vs median: 3 days (range 0-38 days)] in the SG group.
Post-operative complications and mortality
The overall 3.02% incidence of early (<30 days) post-operative complications observed following GBP was significantly higher (p = 0.0006) than the 2.13% seen after SG. Bleeding was the most common complication for both groups. Post-operative leak rate was significantly higher (p=0.01) in the GBP group. Only 2 patients, one in each group died in the first 30 post-operative days. (SG 0,016 % vs GBP 0,009 % - NS).
Re-admissions and re-operation rate
From SG group 103 patients-1.61 % and 206 patients-1.94 % from GBP group required re-admission following hospital discharge in the first 30 days following bariatric surgery - NS. One patient in after GBP re-admitted with two complications. Significantly more intra-abdominal abscesses was the reason for re-admission in the SG group, while no difference in the rest of the complications was presented between the two study groups. From the SG group 78 patients from those required re-admission were re-operated (75.80 %) vs 104 patients (50.50%) from the GBP group (p<0.0001).
Late post-operative complications-re-operation rate and late mortality
Significantly more (p<0.0001) patients from the GBP group (351pts – 3.30%) developed complications requiring hospital admission in the late post-operative period (>30 days), comparing with those from the SG group (61 pts – 0.95%). Six patients after SG developed two complications requiring hospital admission. Intestinal Obstruction and anastomotic ulcer were the complications most commonly developed in the GBP group (p<0.0001). However, the re-operation rate of the re-admitted patients in the late post-operative period, was not statistically different among both study groups (55.80% in SG vs 63.50% in GBP, p=0.3 NS). Weight loss
Significantly better weight loss were seen following GBP in all post-operative years. Weight loss was peaked at the 18th month after surgery for both procedures .
Outcome of obesity co-morbidities
Significantly more patients have their HPT resolved following GBP than after SG in the first (48% vs 44%, p=0.018) and second (55% vs 49%, p=0.023) post-operative year. However, in the subsequent years there were no differences in HPT resolution following either procedure.
T2DM resolution were observed in 60.1% of patients after GBP, as compared to 54.2% following SG, in the first post-operative year (p=0.005). No differences were observed in T2DM resolutions in the subsequent years following the two studied procedures.
Better sleep apnea remission rate was seen following GBP in the first post-operative year (68% vs 60% p=0.0002), but in the subsequent 2nd, 3rd, 4th and 5th year after bariatric surgery, there were no statistically significant difference in the remission rate of this co-morbidity among the two procedures.
Similar results were observed for dyslipidemia, were GBP patients showed higher remission rate the first post-operative year (57% vs 39% p=0.0001), but equal rate for dyslipidemia remission, with the SG patients, in the subsequent 5 post-operative years.
Finally significantly better results (p<0.0001 for all comparisons) in terms of treatment of osteoarticular disease were seen after SG in the first (44% vs 35%) and the subsequent post-operative years (60% vs 47% in 2nd, 76% vs 53% in 3rd, 78% vs 53% in 4th and 78% vs 56% in the 5th post-op year).
ANALYSIS
Data from the International Bariatric Registry (IBAR) shows that SG has gained popularity in the last 5 years and is now the mostly used bariatric operation among the surgeon’s participating at the COE program in the area of Europe, Middle East and Africa.
This can be explained due to the simplicity and efficacy of this operation. This procedure was the surgeon’s preference in case of adolescence and super obese cases in this study. Avoiding technically demanding anastomosis in the heavier patients and the long-life supplementation in the younger patients is a possible explanation for this preference.
However, in case of co-morbid condition, such as diabetes type 2 and hypertension, most surgeons had chosen GBP, possibly due to the fact that this procedure is used for longer period of time having proven its ability to treat obesity co-morbidities particularly type 2 diabetes.
As this study shows, both procedures were performed laparoscopically in the vast majority of the cases with the same conversion rate, even when SG was utilized in heavier individuals. There were also no statistically significant differences concerning intraoperative complications, nor in the 30 days mortality which was extremely low for both procedures.
However, there were more post-op complications in the GBP group with leak rate 0.36% vs 0.15% in the GBP group. There were also no differences in the re-admission rate between the two procedures, but more patients were re-admitted due to intra-abdominal abscess following SG.
From those patients who were re-admitted in the SG group, 75.72% required re-operation and this is statistically significant, as compared with the 50.50% re-operations in the GBP group.
As far as the long-term outcome following GBP is concerned, there were significantly more complications (3.30%) requiring admission in the hospital, compared to the long-term complications noticed after SG (0.99%).
However, from the re-admitted patients, re-operation required for 55.8% in the SG group and this is not statistically different from the 63.5% of the re-operated patients after GBP. The weight-loss after GBP was significantly greater than after SG in all post-operative years of the study on the 12th and up to the 60th post-operative month. Significantly better results in remission of diabetes, dyslipidemia and sleep apnea syndrome occur after GBP in the first post-operative year. In the following 2nd, 3rd, 4th and 5th year of follow-up, both procedures proved to be equally capable to treat the above conditions. GBP showed better results in the treatment of hypertension on the first and the second post-operative year, while in the subsequent years of follow-up, there were no statistically significant differences in the ability of both procedures to treat this disease.
The better results seen after GBP in the early post-operative period in controlling the above conditions can be explained by the greater weight-loss observed after this procedure. However, in the later post-operative period and up to the 5th post-operative year and despite the greater weight-loss after GBP, no difference in remission rate was noted between the two bariatric operations despite that greater weight-loss was observed after GBP for all post-operative years.
On the contrary, better remission rate for osteo-articular disease was evidenced after SG in the first and all subsequent years of the study. This may be explained by the higher incidence of this condition preoperatively in the heavier patients that underwent SG.
This study has a number of limitations. The reported results are representative of the management offered to morbidly obese patients in highly specialized Centres by experienced bariatric surgeons fulfilling the IFSO requirements for the safe and effective management of the severely obese individuals.
Therefore, this may not accurately represent the average outcome of the bariatric procedure in the region of Europe, Middle East and Africa.
Additionally, the reported data in the IBAR are partially verified by site visitation particularly to the designated Centres of Excellence.
In conclusion, both procedures were performed in institutions participating in IFSO-EC COE program with extremely low morbidity, mortality, complication and re-operation rates.SG was performed in younger and heavier patients and GBP in patients with more co-morbidities. Greater weight-loss was noted after GBP, but the remission of co-morbidities such as diabetes, hypertension and sleep apnea was equally satisfying after both procedures in the long term.
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Σύσταση και λειτουργία Πανευρωπαϊκού δικτύου Κέντρων Αριστείας (Centers of Excellence) στην Βαριατρική Χειρουργική
