Preamble
History
Rationale and objective
Where do these guidelines apply?
Who are the target users?
How long are these guidelines valid for?
Update and monitoring
Material and methods
Guideline development group
Topics
Systematic review
Evidence synthesis
Evidence-to-decision framework
- A strong recommendation for the intervention or the comparator,
- A conditional recommendation for the intervention or the comparator, or
- No recommendation (conditional recommendation for either the intervention or the comparator) [19].
Delphi process
Survey
Appraisal
Results
Indication for bariatric surgery | Laparoscopic bariatric surgery should be considered for patients with BMI ≥ 40 kg/m2 and for patients with BMI ≥ 35–40 kg/m2 with associated comorbidities that are expected to improve with weight loss | Strong |
Laparoscopic bariatric/metabolic surgery should be considered for patients with ≥ BMI 30–35 kg/m2 and type 2 diabetes and/or arterial hypertension with poor control despite optimal medical therapy | Strong | |
Preoperative work-up | No recommendation can be made for either routine H. pylori eradication or no eradication prior to bariatric surgery on the basis of available evidence | Conditional for either intervention or comparator |
Preoperative dietitian consultation should be considered for patients undergoing bariatric surgery | Strong | |
Esophagogastroscopy can be considered as a routine diagnostic test prior to bariatric surgery | Conditional | |
Psychological evaluation can be considered before bariatric surgery A previous diagnosis of binge eating or depression may not be considered as an absolute contraindication to surgery | Conditional | |
Perioperative management | Screening for obstructive sleep apnea using the STOP-BANG criteria can be considered prior to bariatric surgery | Conditional |
Perioperative CPAP should be considered in patients with severe obstructive sleep apnea syndrome who are undergoing bariatric surgery | Strong | |
No recommendation can be made on the dose and duration of pharmacological thromboprophylaxis in patients after bariatric surgery | Conditional for either intervention or comparator | |
Inferior vena cava filter is not recommended for thromboprophylaxis in patients undergoing bariatric surgery | Strong | |
No recommendation for either an ERAS protocol or standard care can be made on the basis of available evidence | Conditional for either intervention or comparator | |
Perioperative multimodal analgesia with minimal opioid usage may be considered in patients undergoing bariatric surgery | Conditional | |
Non-bypass procedures | Adjustable gastric banding surgeries are associated with a high rate of reoperations for complications or conversion to another bariatric procedure for insufficient weight loss in the long term | Position statement |
Sleeve gastrectomy may be preferred over adjustable gastric banding for weight loss and control/resolution of metabolic comorbidities | Conditional | |
Sleeve gastrectomy may offer improved short-term weight loss and resolution of type 2 diabetes compared to gastric plication. No significant differences are observed at mid-term. Long-term comparative data on weight loss and metabolic effects are, however, lacking | Position statement | |
There is insufficient evidence to recommend routine stapler line reinforcementa to reduce the leak rate | Position statement | |
Staple line reinforcementa in sleeve gastrectomy should be considered to reduce the risk of perioperative complicationsb | Strong | |
A bougie size < 36F compared to a bougie sized ≥ 36F may be recommended for calibration in sleeve gastrectomy as it is associated with greater weight loss in the mid-term | Conditional | |
More extensive antral resection (2–3 cm from the pylorus versus > 5 cm antral preservation) potentially offers greater weight loss in the short term without a significant increase in post-operative complications. Long term data are, however, lacking | Position statement | |
Bypass procedures | RYGB should be preferred over adjustable gastric banding | Strong |
RYGB results in greater weight loss and control/remission of insulin resistance and type 2 diabetes compared to gastric plication | Position statement | |
RYGB offers similar mid-term weight loss and control/remission of metabolic comorbidities compared to sleeve gastrectomy. Long-term comparative data are, however, lacking | Position statement | |
RYGB can be preferred over sleeve gastrectomy in patients with severe gastroesophageal reflux disease and/or severe esophagitis | Conditional | |
No recommendation for either BPD/DS or sleeve gastrectomy can be made on the basis of available comparative evidence | Conditional for either intervention or comparator | |
With regard to mid-term weight loss there is no difference between BPD/DS and RYGB. BPD/DS is superior to RYGB for control/remission of type 2 diabetes. Long-term comparative data are, however, lacking | Position statement | |
One anastomosis procedures | OAGB may offer greater short-term weight loss compared to RYGB, gastric plication, adjustable gastric banding and sleeve gastrectomy. Long-term comparative data are, however, lacking. The effect on nutritional deficiencies remains controversial | Position statement |
No recommendation on SADI-S compared with OAGB, BPD/DS, RYGB or sleeve gastrectomy can be made on the basis of available evidence | Conditional for either intervention or comparator | |
Revisional surgery | No evidence-based criteria for indication to revisional bariatric/metabolic surgery are available to date The panel advises that the clinical decision to proceed to revisional bariatric/metabolic surgery be based on a complete multidisciplinary assessment of the patient, as recommended for the primary procedure | Position statement |
Postoperative care | Scheduled multidisciplinary post-operative follow-up should be provided to every patient undergoing bariatric/metabolic surgery | Strong |
Treatment with ursodeoxycholic acid could be considered during the weight loss phase to prevent gallstones formation | Conditional | |
Micro and/or macronutrients supplementation is recommended after bariatric surgery according to the type of the procedure and to the deficiencies documented during the follow-up | Strong | |
PPI therapy should be given to patients undergoing bypass procedures for the prevention of marginal ulcers | Strong | |
Postoperative nutritional and behavioral advice should be provided to patients undergoing bariatric surgery | Strong | |
Pregnancy following bariatric surgery should be delayed during the weight loss phase | Strong | |
Investigational procedures | For duodenal-jejunal bypass sleeves, aspiration devices, gastric electrical stimulation, vagal blockade and duodenal mucosal resurfacing, the quality of evidence was too low to provide any recommendations | Position statement |
Endoluminal suturing procedures may have a role in the treatment of patients with obesity with BMI < 40 kg/m2 | Position statement |
Topic 1: indication for bariatric surgery
Bariatric surgery versus medical management for morbid obesity
Laparoscopic bariatric surgery should be considered for patients with BMI ≥ 40 kg/m2 and for patients with BMI ≥ 35–40 kg/m2 with associated comorbidities that are expected to improve with weight loss
Strong recommendation
Laparoscopic bariatric/metabolic surgery should be considered for patients with ≥ BMI 30–35 kg/m2 and type 2 diabetes and/or arterial hypertension with poor control despite optimal medical therapy
Strong recommendation
|
Justification
Topic 2: preoperative work-up
Preoperative H. pylori eradication versus standard care in patients undergoing bariatric surgery
No recommendation can be made for either routine H. pylori eradication or no eradication prior to bariatric surgery on the basis of available evidence. Conditional recommendation for either the intervention or the comparator |
Justification
Preoperative diet consultation versus standard care in patients undergoing bariatric surgery
Preoperative dietitian consultation should be considered for patients undergoing bariatric surgery
Strong recommendation
|
Justification
Preoperative endoscopy versus no endoscopy in patients undergoing bariatric surgery?
Esophagogastroscopy can be considered as routine diagnostic test prior to bariatric surgery
Conditional recommendation
|
Justification
Assessment of preoperative psychological conditions versus no assessment in patients undergoing bariatric surgery
Psychological evaluation can be considered before bariatric surgery A previous diagnosis of binge eating or depression may not be considered as an absolute contraindication to surgery
Conditional recommendation
|
Justification
Topic 3: perioperative management
Screening versus no screening for obstructive sleep apnea in patients prior to bariatric surgery
Screening for obstructive sleep apnea using the STOP-BANG criteria can be considered prior to bariatric surgery
Conditional recommendation
|
Justification
Perioperative continuous positive airway pressure (CPAP) versus no CPAP in patients with severe sleep apnea syndrome
Perioperative CPAP should be considered in patients with severe obstructive sleep apnea syndrome who are undergoing bariatric surgery
Strong recommendation
|
High-dose versus standard-dose pharmacological antithrombotic prophylaxis after surgery
No recommendation can be made on the dose and duration of pharmacological thromboprophylaxis in patients after bariatric surgery
Conditional recommendation for either the intervention or the comparator
|
Justification
Inferior vena cava filter versus standard care for prevention of thromboembolic events after bariatric surgery
Inferior vena cava filter is not recommended for thromboprophylaxis in patients undergoing bariatric surgery
Strong recommendation
|
Enhanced recovery after surgery (ERAS) protocol versus standard care for bariatric surgery
No recommendation for either an ERAS protocol or standard care can be made on the basis of available evidence
Conditional recommendation for either the intervention or the comparator
|
Justification
Multimodal analgesia with minimal use of opioids versus standard analgesia in bariatric surgery
Perioperative multimodal analgesia with minimal opioid usage may be considered in patients undergoing bariatric surgery
Conditional recommendation
|
Justification
Topic 4: operative procedures
Non-bypass procedures
Adjustable gastric banding
Position Statement Adjustable gastric banding surgeries are associated with a high rate of reoperations for complications or conversion to another bariatric procedure for insufficient weight loss in the long term |
Justification
Sleeve gastrectomy versus adjustable gastric banding
Sleeve gastrectomy may be preferred over adjustable gastric banding for weight loss and control/resolution of metabolic comorbidities
Conditional recommendation
|
Justification
Sleeve gastrectomy versus gastric plication
Position statement Sleeve gastrectomy may offer improved short-term weight loss and resolution of type 2 diabetes compared to gastric plication. No significant differences are observed at mid-term. Long-term comparative data on weight-loss and metabolic effects are, however, lacking |
Justification
Technical considerations on sleeve gastrectomy: Staple line reinforcement
Position statement There is insufficient evidence to recommend routine stapler line reinforcement* to reduce the leak rate
*Buttress, glues, suturing, clips,
|
Recommendation Staple line reinforcement* in sleeve gastrectomy should be considered to reduce the risk of perioperative complications**
Strong recommendation
*Buttress, glues, suturing, clips,
**Overall mortality, bleeding
|
Justification
Technical considerations on sleeve gastrectomy: Bougie size
A bougie size < 36F compared to a bougie sized ≥ 36F may be recommended for calibration in sleeve gastrectomy as it is associated with greater weight loss in the mid-term
Conditional recommendation
|
Justification
Technical considerations on sleeve gastrectomy: antral resection
Position Statement More extensive antral resection (2–3 cm from the pylorus versus > 5 cm antral preservation) potentially offers greater weight loss in the short term without a significant increase in post-operative complications. Long term data are, however, lacking |
Justification
Bypass procedures
Roux-en-Y gastric bypass (RYGB) versus adjustable gastric banding
RYGB should be preferred over adjustable gastric banding
Strong recommendation
|
Justification
RYGB versus gastric plication
Position Statement RYGB results in greater weight loss and control/remission of insulin resistance and type 2 diabetes compared to gastric plication |
Justification
RYGB versus sleeve gastrectomy
Position Statement RYGB offers similar mid-term weight loss and control/remission of metabolic comorbidities compared to sleeve gastrectomy. Long-term comparative data are, however, lacking RYGB can be preferred over sleeve gastrectomy in patients with severe gastroesophageal reflux disease and/or severe esophagitis
Conditional recommendation
|
Justification
Biliopancreatic diversion with duodenal switch (BPD/DS) versus sleeve gastrectomy
No recommendation for either BPD/DS or sleeve gastrectomy can be made on the basis of available comparative evidence
Conditional recommendation for either the intervention or the comparator
|
Justification
BPD/DS versus RYGB
Position Statement With regard to mid-term weight loss there is no difference between BPD/DS and RYGB. BPD/DS is superior to RYGB for control/remission of type 2 diabetes. Long-term comparative data are, however, lacking |
Justification
One anastomosis procedures
One anastomosis gastric bypass (OAGB)
Position Statement OAGB may offer greater short-term weight loss compared to RYGB, gastric plication, adjustable gastric banding and sleeve gastrectomy. Long-term comparative data are, however, lacking. The effect on nutritional deficiencies remains controversial |
Justification
Single anastomosis duodeno-ileal bypass with sleeve gastrectomy (SADI-S)
No recommendation on SADI-S compared with OAGB, BPD/DS, RYGB or sleeve gastrectomy can be made on the basis of available evidence
Conditional recommendation for either the intervention or the comparator
|
Justification
Topic 5: revisional surgery
Position Statement No evidence-based criteria for indication to revisional bariatric/metabolic surgery are available to date The panel advises that the clinical decision to proceed to revisional bariatric/metabolic surgery be based on a complete multidisciplinary assessment of the patient, as recommended for the primary procedure |
Terminology
Clinical indications for revisional surgery
Work-up in case of revisional surgery
Topic 6: postoperative care
Scheduled multidisciplinary post-operative follow-up versus standard care
Scheduled multidisciplinary post-operative follow-up should be provided to every patient undergoing bariatric/metabolic surgery
Strong recommendation
|
Justification
Treatment with ursodeoxycholic acid during the weight loss phase following bariatric surgery
Treatment with ursodeoxycholic acid could be considered during the weight loss phase to prevent gallstones formation
Conditional recommendation
|
Justification
Supplementation of micro and/or micronutrients after bariatric surgery
Micro and/or macronutrients supplementation is recommended after bariatric surgery according to the type of the procedure and to the deficiencies documented during the follow-up
Strong recommendation
|
Justification
Proton-pump inhibitor (PPI) therapy after bariatric surgery for the prevention of marginal ulcers
PPI therapy should be given to patients undergoing bypass procedures for the prevention of marginal ulcers
Strong recommendation
|
Justification
Postoperative nutritional and behavioral advice versus standard care
Postoperative nutritional and behavioral advice should be provided to patients undergoing bariatric surgery
Strong recommendation
|
Justification
Delaying pregnancy following bariatric surgery until after the weight loss phase versus no delay on fetal complications
Pregnancy following bariatric surgery should be delayed during the weight loss phase
Strong recommendation
|
Justification
Topic 7: investigational procedures
Position statement For duodenal-jejunal bypass sleeves, aspiration devices, gastric electrical stimulation, vagal blockade and duodenal mucosal resurfacing, the quality of evidence was too low to provide any recommendations |
Endoluminal suturing procedures may have a role in the treatment of obese patients with BMI below 40 kg/m2 |