According to the 2008 China national diahetes and metabolic disordersstudy of the Chinese Medical Association, the overall prevalence of diabetes mellitus (DM) in people over 20 years of age in China was 9.7%, with 10.6% in men and 8.8% in women. The total number of people with DM in China is estimated to be 92.4 million, ranking first in the world.
The prevalence of pre-DM is as high as 15.5%, and the estimated number of people is about 150 million. And the prevalence of DM has a tendency to increase further, and the data in 2010 showed that the prevalence of DM has reached 11.6%. Among all types of DM, type 2 diahetesmellitus (T2DM) patients account for about 90%.
Obesity is one of the important risk factors for DM, and the latest national obesity and metabolic syndrome survey results show that the prevalence of dm among overweight [body mass index (BMI) of 25.0<27.5] and obese (bmi≥27.5) people in China is 12.8% and 18.5%, respectively, among which the prevalence of dm among adult males is 33.7% and 13.7%, respectively. The prevalence of dm was 29.2% and 10.7% in adult females, respectively. The mean bmi of all t2dm patients was 25.0.
In 1980, Pories et al. performed gastric bypass surgery to treat obesity and found that patients with combined T2DM had a rapid return to normal blood glucose after surgery, and some patients could even stop taking glucose-lowering drugs. 2004, Ferchak et al. found in a prospective controlled study that obese patients with combined T2DM who underwent gastric bypass surgery did not need drugs to lower their blood glucose and could maintain normal blood glucose for a long time. The number of cases was significantly higher than the non-operative group, and the incidence of diabetes-related complications and mortality rates were significantly lower.
Arterburn et al. also found that patients m showed beneficial changes such as lower systolic blood pressure, improved dyslipidemia, and reduced risk of cardiovascular disease after surgery. As a result, a new discipline, metaholic surgery, has emerged.
In 2009, the American Diabetes Association (ADA) officially listed metaholic surgery as one of the treatments for obesity combined with T2DM in its T2DM treatment guidelines, and in 2011, the International Diahetes Federation (IDF) officially recommended metaholic surgery as one of the treatments for obesity combined with T2DM. In 2011, the International Diahetes Federation (IDF) officially recommended metabolic surgery as a treatment for obesity combined with T2DM.
Health economics studies have found that metabolic surgery can reduce the long-term treatment costs and improve the quality of patient survival, thus reducing the family and socio-economic burden of obese patients with combined T2DM.
The surgical treatment of obesity and diabetes in China began in 2000, and under the organization of Chengzhu Zheng and other experts in bariatric and metabolic surgery, the Chinese Guidelines for the Surgical Treatment of Obesity (2007), the Chinese Expert Guidelines for the Surgical Treatment of Diabetes (2010), the Expert Consensus on the Surgical Treatment of Diabetes, and the Expert Consensus on the Indications and Contraindications for the Surgical Treatment of Diabetes (2013 edition) were formulated and published (Discussion Draft)”, which provides an important basis and specification for the development of bariatric and metabolic surgery in China.
In recent years, the number of bariatric and metabolic surgery cases in China has increased rapidly, but a series of problems have emerged accordingly. Due to the lack of standardized training for hospitals and operators, there is no consistency in the selection of surgical indications and surgical methods, and the mastery of surgical operation points.
In order to meet the needs of the development of bariatric and metabolic surgery in China, the Chinese Society for MetaboliC & Bariatric Surgery (CSMBS) was established in 2012 by the Chinese Society of Surgeons.
Although the evidence-based medical class I evidence for surgical treatment of T2DM in China is currently insufficient, clinical practice experience shows that the treatment effect of such surgery for obesity and T2DM patients in China is similar to that reported in western countries.The Chinese Society for MetaboliC & Bariatric Surgery Guidelines (2014) was developed by CSMBS to standardize the application of bariatric surgical modalities for the treatment of metabolic diseases such as T2DM and to promote its healthy and orderly development.
This guideline focuses on the category of treating T2DM by means of bariatric surgery as the primary purpose, referring to the previous expert guidance and consensus in China, as well as the various editions of guidelines in the United States and other western countries, absorbing and adopting the relevant literature in this field in China in recent years, and writing according to the current situation and the physical characteristics of the population in China.
1. Indications and contraindications for surgery
1.1, indications for surgery
(I) T2DM disease duration ≤ 15 years, and the islets still have some insulin secretion function, fasting serum C peptide ≥ 1/2 of the lower limit of normal value.
(2) The patient’s BMI is an important clinical criterion to determine the suitability of surgery (Table 1).
(3) The recommended grade of surgery may be increased at the discretion of men with waist circumference ≥ 90 Cm and women with waist circumference ≥ 85 cm.
(4) The recommended age is 16~65 years old.
1.2. Contraindications to surgery
(1) Clear diagnosis of non-obese type 1 diabetes.
(2) Basic loss of pancreatic islet B-cell function, low serum C-peptide level or low flat C-peptide release curve under glucose load.
(3) Surgery is not currently recommended for those with BMI < 25.0.
(4) Patients with gestational diabetes mellitus and certain specific types of diabetes mellitus.
(5) Drug or alcohol abuse or addiction or mental illness that is difficult to control.
(6) Those with mental retardation or intellectual immaturity and unable to control their behavior.
(7) Those whose expectations of surgery are not realistic
(8) Those who are unwilling to assume the risk of potential complications of surgery
(9) Those who are unable to cooperate with postoperative diet and lifestyle changes and have poor compliance
(10) Poor general condition, difficult to tolerate general anesthesia or surgery.
1.3.Surgical treatment
T2DM clinical outcome evaluation criteria
(1) Ineffective: no significant improvement in blood glucose and glycated hemoglobin (HhAlc,) compared with those before surgery; no significant reduction in the type and dose of hypoglycemic drugs compared with those before surgery.
(2) Significant improvement: significant reduction in the type or dose of glucose-lowering drugs compared with that before surgery; postoperative HhAlC <7.5%. < p="">
(3) Partial remission: postoperative glycemic control by lifestyle intervention only; 6.5% ≤ HbAle< 7.0%; fasting blood glucose (FPG) 5.6~6.9 mmol/L and 2h postprandial glucose 7.8~11.0 mmol/L; must be maintained for more than 1 year.
(4) Complete remission: no need to take glucose-lowering drugs after surgery, only through lifestyle interventions to control blood glucose; HhAlC < 6.5%; FPG < 5.6 mmol/L and 2h postprandial blood glucose < 7.8 mmol/L; must be maintained for more than 1 year.
(5) Long-term remission: achieve complete remission and maintain it for more than 5 years.
2.Rational selection of surgical methods
The development of bariatric metabolic surgery over the decades has resulted in a variety of surgical procedures, and there are four standard procedures that are generally accepted at present: laparoscopic Roux-en-Y gastric bypass (LRYGB), laparoscopic sleeve gastrectomy (LSG), laparoscopic adjustable gastric banding (LRYGB), and laparoscopic gastric bypass (LSG). laparoscopic adjustable gastric handing (LAGB), biliopancreatic diver-sion with duodenal switch (BPD-DS), and other improved or new procedures still lack long-term evidence support.
Minimally invasive laparoscopic surgery is highly recommended because it is significantly lower than open surgery in terms of early postoperative morbidity and mortality and complication rates.
2.1, LRYGB
LRYGB is the most common and effective procedure for weight loss metabolic surgery. In addition to significant weight loss, it also has a high degree of improvement on glucose metabolism and other metabolic indicators, and can be the procedure of choice for weight loss metabolic surgery. According to the meta-analysis of large samples from western countries, the percentage of excess weight loss (%EWL) 1 year after RYGB is 65%-70%, and the remission rate of T2DM is 80%-85%. The incidence of postoperative complications such as anastomotic ulceration and gastroesophageal reflux is about 5%, and the procedure-related morbidity and mortality rate is about 0.5%.
Key points of LRYGB operation (recommended): establish a volume <50 30="">200 cm, which can be adjusted according to the patient’s BMI, the degree of T2DM onset and the specific situation (clinical experience shows that the longer the bypass intestinal collaterals, the better the postoperative results); it is recommended that the diameter of the gastrojejunal anastomosis is <1.5 cm, and try to close the mesenteric fissure to prevent postoperative internal hernia.
2.2, LSG
LSG is a type of surgery that focuses on restricting gastric volume, maintaining the original gastrointestinal anatomical relationship, and can change some of the gastrointestinal hormone levels. It has a good degree of improvement on glucose metabolism and other metabolic indexes in patients with T2DM, and can be applied as a stand-alone surgery or as the first stage of weight reduction surgery for patients with severe obesity (BMI>50).
According to the meta-analysis of large samples from western countries, the %EWL at 1 year after SG is 30%-60%, and the remission rate of T2DM is about 65%. The incidence of postoperative complications such as gastrointestinal leakage and gastroesophageal reflux was approximately 3.3%, and the rate of surgery-related morbidity and mortality was <0.5%. < p="">
Key points of LSG operation (recommended): complete freeing of the fundus and the greater curvature of the stomach, application of a 32-36 Fr balloon gastric tube as an intragastric support, 2-6 cm from the pylorus as the starting point of gastric sleeve resection, upward cutting closure, complete resection of the fundus, complete preservation of the cardia, and creation of a 60-80 mL volume sleeve stomach. If an esophageal hiatal hernia is found intraoperatively, it should be treated at the same time.
2.3.BPD-DS
BPD-DS is a procedure that focuses on reducing nutrient absorption in the intestine, which is better than the other three procedures in terms of weight loss and metabolic index control, and can correct insulin resistance, but it is more difficult to operate, and with the shortening of the common intestinal length, the risk of nutritional deficiency increases accordingly, and there are many postoperative nutrition-related complications, and the complication rate and morbidity and mortality rate are higher than those of other procedures, so it is recommended to adopt it cautiously.
The %EWL at 1 year after surgery is 70%, and the remission rate of T2DM reaches 95%~100%. The incidence of postoperative complications is about 5.0% and the surgery-related morbidity and mortality rate is 1.0%.
The BPD-DS recommendations include a gastric sleeve resection with a volume of 100-200 mL, preservation of the pylorus and transection of the upper duodenum, and transection of the small intestine at a distance of approximately 250 cm from the ileocecal valve. The distal end of the duodenal transection was closed with an anastomosis, and the proximal end of the duodenal transection was anastomosed with the distal end of the small intestine, and the proximal end of the small intestine transection was anastomosed with the ileum at a distance of 50-100 cm from the ileocecal valve.
2.4. LAGB
LAGB is a surgical procedure to achieve weight loss by simply restricting gastric volume and reducing food intake. There is a lack of medium- and long-term efficacy data, and it is not recommended for patients with the purpose of treating type 2 diabetes for the time being.
The following factors should be taken into consideration when choosing the procedure: the primary goal of the procedure (simple weight loss or treatment of metabolic disease); local medical resources (surgeon’s skills and equipment); the patient’s personal wishes and preferences and expectations for the outcome of the procedure; patient risk stratification, taking into account the patient’s age, duration of DM, cardiopulmonary status, awareness and cooperation with postoperative nutritional therapy, follow-up, and financial status. The patient’s risk stratification should take into account the patient’s age, duration of DM, cardiopulmonary status, awareness and cooperation with postoperative nutritional therapy, compliance with follow-up and economic status.
3. Preoperative assessment and preparation
3.1 Preoperative assessment
The preoperative evaluation should be conducted by a multidisciplinary team (MDT), and the MDT should generally include a bariatric surgeon, an endocrinologist, a psychiatrist and a nutritionist as core members, as well as a joint consultation with anesthesiologists, respiratory medicine, cardiology and other specialists according to the patient’s specific situation, with the aim of clarifying whether the indication for surgery is met, whether there are contraindications to surgery, assessing the risks of surgery and how to reduce the risks of surgery. The purpose of the consultation was to clarify whether the surgical indications were met, whether there were any contraindications to surgery, the assessment of surgical risks and how to reduce the surgical risks. The specific assessment items are shown in Table 2.
3.2. Pre-operative preparation
(1) routine preoperative preparation for gastrointestinal surgery; (2) reasonable control of blood glucose and weight before surgery to reduce the difficulty and risk of surgery; (3) treatment and control of other co-morbidities to reduce the risk of surgery and improve the effect of surgical treatment.
4.Postoperative complications
4.1.Common gastrointestinal complications
Bleeding, gastrointestinal leakage, gastroesophageal reflux, ulcers, etc., can be routinely treated.
4.2.Pulmonary embolism
Pulmonary embolism is one of the acute complications after surgery in obese patients, and bed rest will increase its incidence. Prevention is the main concern. It is recommended to leave bed early after surgery, and anticoagulant drugs can be given appropriately in the perioperative period for high-risk patients.
4.3.Deep vein thrombosis (DVT)
DVT should be mainly prevented. For patients with high-risk factors, the application of continuous compression devices and subcutaneous injection of heparin or low-molecular heparin 24 h after surgery are recommended, and early out-of-bed activity is recommended.
4.4. Internal hernia
It is recommended to close the tethered fissure intraoperatively to prevent the occurrence of internal hernia after surgery.
4.5. Respiratory complications
For those with clinical symptoms, oxygen should be given. Early postoperative continuous positive airway pressure ventilation (CPAP) has been reported to reduce the risk of postoperative atelectasis and pneumonia.
4.6. Cholecystitis and gallstone formation
If weight loss is too rapid, ursodeoxycholic acid may be considered to prevent cholecystitis and gallstone formation.
5.Perioperative management
5.1.Perioperative blood glucose management
For obese patients with combined T2DM, fasting, pre-meal, 2h post-meal and bedtime fingertip blood glucose should be monitored, oral medication or insulin should be given to control blood glucose <10 mmol/L before surgery. insulin stimulants (sulfonylurea and clofibrate) should be stopped after surgery, and insulin dose should be adjusted to reduce the risk of hypoglycemia. Outpatients who do not achieve their postoperative glycemic goals may be treated with antidiabetic agents that improve insulin sensitivity (metformin) and enteral insulinotropic drugs.
If T2DM is in remission after surgery, the application of anti-diabetic drugs should be stopped; hyperglycemic patients with poor postoperative glycemic control should be guided by endocrinologists.
5.2. Postoperative nutritional management
The principles of postoperative nutritional management are as follows.
(1) Sufficient daily intake of water, recommended ≥ 2000 mL.
(2) Adequate daily protein intake, 60-80 g/d is recommended, and for patients with BPD-DS, protein intake should be increased by 30% on top of this.
(3) Supplementation with adequate amounts of multivitamins and trace elements, all given in oral chewable or liquid form for 3 months after surgery. Patients with BPD-DS should also receive fat-soluble vitamins, including vitamins A, D, E and K.
(4) Minimize the intake of carbohydrates and fats.
5.3. Perioperative dietary management
The perioperative and postoperative diets should be administered according to the following steps.
(1) Give a sugar-free, caffeine-free, low-calorie or calorie-free clear liquid diet 24 h before surgery.
(2) Fasting on the day of surgery.
(3) Sugar-free, caffeine-free, low-calorie or calorie-free clear liquid food can be started on the next postoperative day, with clear liquid food every 15 minutes.
(4) Low-sugar, low-fat, non-caffeinated clear liquid food with water every 15 min and calorie-containing clear liquid food every hour should be given from 2 d to 3 weeks after surgery.
(5) Low-sugar, low-fat, non-caffeinated semi-liquid and soft foods were given from 3 weeks to 3 months after surgery.
(6) Gradually add indolent food more than 3 months after surgery until normal eating is resumed.
5.4. Postoperative follow-up and monitoring
Long-term postoperative follow-up and monitoring of patients according to the plan is the key to ensure the postoperative efficacy. The postoperative follow-up items are shown in Table 3.
Other precautions.
(1) Any abnormalities in the above monitoring should be corrected according to the actual situation.
(2) For patients with severe obesity, monitor serum creatine kinase (CK) level and urine volume to exclude rhabdomyolysis.
(3) Women of childbearing age should avoid pregnancy for 1 year after surgery and should be given appropriate contraceptive measures. Maternal vitamin and micronutrient levels, including serum iron, folic acid, vitamin B12, vitamin K1, serum calcium, and fat-soluble vitamins, should be closely monitored for fetal health regardless of when pregnancy occurs after surgery.
(4) Patients are advised to perform moderate aerobic exercise in divided sessions, with a minimum of 150 min per week and a target of 300 min per week.
6.Conclusion
For obese T2DM patients, some surgical modalities of bariatric surgery are more effective than intensive drug therapy in their treatment. Although conservative treatment and drug therapy remain the preferred treatment modality for T2DM, bariatric surgery may be an option for the treatment of T2DM in cases where blood glucose cannot be effectively controlled. The prerequisite for surgical treatment of T2DM is that the patient still has sufficient islet function reserve.
The establishment of MDT, strict selection of patients and suitable surgical modality, adequate preoperative evaluation and preparation, and strengthening postoperative follow-up and nutrition and exercise guidance are the keys to improve the effectiveness and safety of surgical treatment of T2DM. Meanwhile, retrospective research studies and prospective randomized controlled clinical trials are encouraged to establish and accumulate evidence-based medicine for the Chinese population.
The treatment flow of obesity and type 2 diabetes is shown in Figure 1.