Padmakumar Ramakrishnapillai1*, Madhukara Pai1, Farish Shams1, Rajeev Jayadevan2, Praveen Kumar3, Shaji P.G4, Anithadevi T Sathyan5, Sulfia Jabbar3, Vani Krishna6, Premna Subin1
1Department of Laparoscopic and Metabolic Surgery, Sunrise Hospital, Kakkanad, Kochi, 682030, Kerala, India
2Department of Gastroenterology, Sunrise Hospital, Kakkanad, Kochi 682030, Kerala, India
3Department of Diabetology, Sunrise Hospital, Kakkanad, Kochi 682030, Kerala, India
4Department of Anesthesiology, Sunrise Hospital, Kakkanad, Kochi 682030, Kerala, India
5Department of Bio-statistics, Sunrise Hospital, Kakkanad, Kochi 682030, Kerala, India
6Department of Dietetics, Sunrise Hospital, Kakkanad, Kochi 682030, India, Data collection and compilation
*Corresponding Author: Ramakrishnapillai Padmakumar, Consultant Surgeon, Department of Laparoscopic and Metabolic Surgery, Sunrise Hospital, Seaport-Airport Road, Kakkanad, Kochi 682030, India, Tel: +91-944-7230370; Fax: +91-484-2428917; E-mail: email@example.com
Published date: June 29, 2015
OBJECTIVE: To evaluate the effectiveness of Laparoscopic Sleeve Gastrectomy (LSG) for resolving type 2 diabetes in obese patients even with BMI<35 kg/m2.
METHODS: A retrospective study was conducted on 90 type 2 diabetic patients with BMI>30 kg/m2 who underwent LSG at Sunrise Hospital, Kochi, India, from September 2009 to February 2014. In this study, we compared preoperative parameters such as BMI, HbA1c and diabetic medications with postoperative parameters during periodic reviews.
RESULTS: Complete resolution of type 2 diabetes found in 86.6%, 91.1%, and 88.4% in patients with obese class I, II & III respectively. The complete resolution of diabetes (F=0.421, P=0.658) and drop in HbA1c (F=0.172, P=0.842) among the BMI groups were statistically not significant, i.e. class I obese patients were equally benefited compared to class II and class III obese patients. Comorbidities also resolved to a good extent; sleep apnea 100%, fatty liver 89.47%, dyslipidemia 88.57%, polycystic ovarian disease 83.33% and hypertension 82.22%. Minor complications were reported in 3.84%, whereas no complications in 96.16% of the patients.
CONCLUSIONS: Laparoscopic sleeve gastrectomy was found to be an effective intervention for obese type 2 diabetic patients, even when BMI is 30-34.9 kg/m2.
Type 2 diabetes makes up about 90% of cases of diabetes while the other 10% are primarily due to diabetes mellitus type 1 and gestational diabetes. Insulin resistance and beta cell failure are the prime causes of type 2 diabetes in people who are genetically predisposed to the disease. Obesity is a major independent risk factor for the development of type 2 diabetes and is associated with the rapid increase in the prevalence of type 2 diabetes. It was found in a study that the majority (68%) of the type 2 diabetes subjects were obese. In comparison with subjects having BMI<25 kg/m2, the relative prevalence of diabetes was about 1.25 times among subjects with BMI between 25 to 29.9 kg/m2, and was elevated about 2.5 times among subjects with BMI>30 kg/m2. Another study quotes that never-obese individuals were 60 times less likely to have diabetes than those with incident obesity.
Laparoscopic sleeve gastrectomy (LSG) is a well established bariatric procedure of treatment for people who are obese and having type 2 diabetes, not achieving desirable control with medical and dietary therapies, especially when there are other major co morbidities. It has shown to dramatically improve glycemic control, leading to complete resolution of type 2 diabetes in the majority of patients, as well as reduction of excess weight. In India, 61.3 million people had been diagnosed with diabetes in 2011 as per International Diabetes Federation (IDF) and are expected to rise dangerously to 101.2 million by 2030. India holds second place, next to China in having the high prevalence of diabetes. In this circumstance, this procedure is of great importance in offering a complete resolution for majority of type 2 diabetes patients.
A systematic review assessing the resolution or improvement in type 2 diabetes mellitus after LSG showed that 66.2% had complete resolution and 26.9 % improved/resolved from diabetes. As per the IDF guidelines, bariatric surgery is an option for T2DM patients with BMI >35 kg/m2 or more. In patients with BMI between 30-34.9 kg/m2 when diabetes cannot be adequately controlled by optimal medical regimen, and in presence of comorbidities, surgery should be considered as an alternative treatment option. In Asians the BMI action point is still lower, i.e. BMI 27.5 kg/m2 . So our aim was to assess the effectiveness of LSG in patients with BMI 30-34.9 kg/m2 and compare the same with that of patients with BMI>35 kg/m2.
This is a retrospective study conducted on 90 type 2 diabetic patients with BMI>30kg/m2 who underwent laparoscopic sleeve gastrectomy (LSG) and were available for follow-up at Sunrise Group of Hospitals, Kochi, India, from September 2009 to February 2014. In order to get 80% power at 5% significance level with 70% of complete diabetes resolution, we needed a minimum of 84 subjects to be studied. Preoperative parameters such as BMI, HbA1c & diabetic medications were compared with those during periodic postoperative reviews at 1 month, 3 months, 6 months and 12 months, to check the resolution rates of diabetes. .
Inclusion criteria for the study were type 2 diabetic patients (HbA1c>6.5%) with BMI>30 kg/m2 who underwent LSG. The study excludes, patients with lower BMI (i.e. BMI<30 kg/m2), patients who were obese but non-diabetic and those who underwent other procedures like gastric bypass, Ileal interposition or revision of bariatric surgeries.
The patients who attained HbA1c level <6.5% without any diabetic medications were considered as complete resolution. Diagnosis of sleep apnea and its resolution were based on patient statements. Diagnosis of fatty liver and its resolution were based on ultrasonographic findings. Diagnosis of hypertension and its resolution were based on clinical assessment and discontinuation of antihypertensive medications. The patients were asked to follow up at specified intervals and thus the study follow-up was conducted. Follow-up data from overseas patients who could not meet in person were obtained through emails.
All the patients underwent a thorough clinical evaluation by a team of doctors including bariatric surgeon, diabetologist, cardiologist, anaesthesiologist, pulmonologist, dietician and diabetes educator. An enquiry regarding duration of type 2 diabetes and other obesity related co morbidities like hypertension, sleep apnea, fatty liver, dyslipidemia, polycystic ovarian disease and infertility were done. The medications that the patients were taking were also recorded. A physical examination to look for acanthosis nigricans, abdominal wall herniation, abdominal and arm sagging was done.
The medical conditions of the patients were stabilized to the maximum that is possible. They were counselled regarding the restriction of diet after procedure and probable complications including gastric leak and hair loss. They were admitted a day prior to the surgery and were kept on liquid diet for 24 hours. Preoperative antibiotics were given as per recommendations and proper consent for surgery obtained.
The procedure was done using a 5 port technique. The 1st port (12 mm) was placed towards left of midline well above umbilicus and the 2nd port (10 mm) was placed towards the left of it. Three 5-mm ports were placed at the right hypochondrium, right midclavicular line and left anterior axillary line respectively. Greater omentum was divided close to stomach along the greater curvature, preserving epiploic arcade towards the omentum. A 38F bougie was placed per-orally and under its guidance stomach was divided 3-5 cm proximal to pylorus. Thus using endostaples, a narrow stomach tube was created and entire fundus was resected. Methylene blue dye was instilled to check gastric leak.
Oral clear fluids were initiated after 24 hours. Tight control of diabetes was maintained in the postoperative period with insulin as and when required. The patients were ambulated within 8 hours and chest physiotherapy was initiated along with leg exercise. Low molecular weight heparin for DVT prophylaxis, antibiotics and analgesics were administered. On the day of discharge the diet chart and diet counselling were given. For 2 weeks the patients were kept on clear-liquid diet like green tea or any herbal tea, black tea, clear vegetable soup, buttermilk, etc., and were asked to take small quantities of liquids frequently. Vitamin supplements and proton pump inhibiters were also provided to the patients. After two weeks vegetable based diet was initiated followed by normal diet in a month’s time. Vitamin supplement discontinued in two month’s time.
There were 90 patients having BMI>30 kg/m2, who underwent LSG. The subjects were classified in three groups based on the guidelines provided by World Health Organization (WHO) i.e. obese class I- BMI 30-34.9 kg/m2, obese class II – BMI 35-39.9 kg/m2, and obese class III – BMI>40 kg/m2, for studying the characteristics of the data. Descriptive statistics were computed on continuous variable, age. The sex ratio was also calculated. Scatter plot was used to study the variation in BMI with time for the whole population. The proportion of patients having complete resolution of diabetes, improved but not fully resolved and sustained medical conditions were calculated. Of the 90 patients, 61 patients who completed 1 year were included in comparing the preoperative HbA1c and 1 year postoperative HbA1c values. Difference in the mean preoperative HbA1c and the mean postoperative HbA1c were computed using paired t-test, p-value<0.05. The differences among the BMI groups were analyzed using one way ANOVA. The percentages of comorbidities resolved were presented graphically using multiple bar diagram. All the statistical analysis was carried out using Statistical Package for Social Sciences (SPSS) version 19.1 and Microsoft office Excel 2007.
The study population consisted of 90 diabetic patients. The mean age of the patients was 43 yrs, ranging from 20 to 63 yrs. The weight of the overall population ranged from a minimum of 63 kg to a maximum of 168 kg. Height varied from 149 cm to 187 cm and BMI ranged a minimum of 30.12 kg/m2 to a maximum of 53.62 kg/m2, giving a mean of 37.58 kg/m2, which decreased to 27.6 kg/m2 within a year. Duration of diabetes was found to be an average of 5 years with range 1 month to 19 years. The blood parameters were, fasting insulin: 25.21 Uu/Ml (mean), fasting c-peptide: 4.04 ng/ml, serum cortisol: 11.27 ug/dL and FBS: 159.57 mg/dl. Eighty four percent of patients were on diabetic medications (Table 1). The reducing trend of BMI during follow-up is shown in the scatter plot. The mean BMI was noted to be 37.16 kg/m2 in the preoperative period and 32.91 kg/m2, 29.53 kg/m2, 28.52 kg/m2, 27.74 kg/m2, 27.65 kg/m2, 27.42 kg/m2 and 26.87 kg/m2 at postoperative periods of 1st month, 3rd month, 6th month, 1 year, 2 year, 3 year and 4 year respectively (Figure 1).