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Medico-Legal Issues in Upper GI and Bariatric Surgery

This presentation discusses common instructions and objectives in upper GI and bariatric surgery, as well as the causes and associated co-morbidities of obesity. It also explores the options and outcomes of bariatric surgical interventions.

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Medico-Legal Issues in Upper GI and Bariatric Surgery

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  1.  Medico-Legal issues in Upper GI and Bariatric SurgeryRoyal College of Physicians 11 St Andrews Place, Regent’s Park Mr Sakhawat (Zak) Rahman MD FRCS Consultant Surgeon HPB – Upper GI – Bariatric – General Surgery

  2. Common Instructions - BOD • The vast proportion of instructions received (Upper GI) are related to benign disease (>90%) • And over 90% of such instructions fall into: • Bariatric Surgery • Anti-reflux and Hiatal Hernia Surgery • Bile duct injuries (Cholecystectomy) • Objectives: • Basic anatomy and pathology • Operative technique, and • Case examples (spent)

  3. Weight Loss SurgerySurgery for ObesityMetabolic Surgery

  4. OECD Predictions for Future Overweight Rates Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes

  5. Causes of Obesity • “Thrifty” Genes • Leptin resistance • Abnormal Ghrelin • Obesogenic intrauterine environment • Maternal starvation • Maternal obesity • Environment (lifestyle) • lack of sleep • lack of physical activity • Marketing (willpower) • Larger portion sizes • Poor diet • Hormonal imbalance • Low levels of Incretins (GIP, GLP-1) • High levels of anti-Incretins Egger G, Swinburn B. An ‘ecological’ approach to the obesity pandemic. BMJ 1997;315:477–80.

  6. Obesity Associated Co-morbidities Pulmonary Disease Abnormal Function Obstructive Sleep Apnea Hypoventilation Syndrome Asthma Idiopathic Intracranial Hypertension Stroke Cataracts Nonalcoholic Fatty Liver Disease Steatosis Steatohepatitis Cirrhosis Coronary Heart Disease Diabetes Dyslipidemia Hypertension Severe Pancreatitis Gall Bladder Disease Cancer Breast, Uterus, Cervix, Colon, Oesophagus, Pancreas, Kidney, Prostate Gynecologic Abnormalities Abnormal Menses Infertility Polycystic Ovarian Syndrome Obesity OnLine Slide Presentation. Accessed May 17, 2007. Accessible as slide #5 at http://www.obesityonline.org/slides/slide01.cfm?tk=33. Osteoarthritis Phlebitis Venous stasis Leg ulcers Skin Gout

  7. NICE: Assessment and offering surgery BMI of 40 kg/m2 or more, or between 35 kg/m2 and 40 kg/m2and other significant disease (for example, type 2 diabetes or high blood pressure) that could be improved if they lost weight. All appropriate non-surgical measures have been tried but the person has not achieved or maintained adequate, clinically beneficial weight loss. The person has been receiving or will receive intensive management in a tier 3 service. The person commits to the need for long-term follow-up. In addition to the criteria listed above, bariatric surgery is the option of choice (instead of lifestyle interventions or drug treatment) for adults with a BMI of more than 50 kg/m2 when other interventions have not been effective. Obesity: identification, assessment and management Clinical guideline [CG189] Published date: November 2014 

  8. Bariatric surgery: Which obese type 2 diabetes should be considered? • Surgery should also be considered as an alternative treatment option in persons with BMI 30 to 35 when diabetes cannot be adequately controlled by optimal medical regimen, especially in the presence of other major cardiovascular disease risk factors • In Asian, and some other ethnicities of increased risk, BMI action points may be lower e.g. BMI 27.5 to 32.5 International Diabetes Federation (IDF) Position Statement Bariatric Surgical and Procedural Interventions in the Treatment of Obese Patients with Type 2 Diabetes Taskforce on Epidemiology and Prevention

  9. NICE: Person with recent-onset type 2 diabetes Offer an expedited assessment for bariatric surgery to people with a BMI of 35 and over who have recent-onset type 2 diabetes as long as they are also receiving or will receive assessment in a tier 3 service (or equivalent). Consider an assessment for bariatric surgery for people with a BMI of 30–34.9 who have recent-onset type 2 diabetes Consider an assessment for bariatric surgery for people of Asian family origin who have recent-onset type 2 diabetes at a lower BMI than other populations Obesity: identification, assessment and management Clinical guideline [CG189] Published date: November 2014 

  10. Obesity / Metabolic Syndrome: Surgical Options Gastric Balloon Gastric Band BPD

  11. NKOTB: Surgical Options

  12. 10-Yr WEIGHT LOSS AFTER VARIOUS BARIATRIC PROCEDURES

  13. Quality of life after bariatric surgeryMajor P. et al. Obesity Surgery 2015

  14. Gastric Banding (LAGB) • Day case laparoscopic procedure • Perceived as the least invasive of the “surgical” procedures • Reversible (the band can be removed) • Costs: Initial band placement & “Package” which includes 1 or 2 year follow-up varies from £3500 - £6000 [Private] • Disadvantages • Often over the phone consultation and booking (huge private market) • Requires compliance with diet and regular attendance for band fills • About 10% of patient do not lose any weight. Average EWL 40% at 2 years • Weight regain is common – lack of compliance with diet and follow-up • Band fills after the “package” and dietary advice come at a cost (approx. £250 -£300 per band fill • Complications are relatively common

  15. GASTRIC BAND Complications • Band slippage (5%) • Can happen at anytime! • Weight regain, dysphagia, vomiting, pain, lack of restriction • Diagnosis: Triple upper GI series • Slippage can cause • secondary band infection as it can erode into the stomach • Massive haemorrhage • Gastric perforation • Management: • Early diagnosis and immediate deflation of the gastric band • Band re-adjustment surgically and or removal

  16. GASTRIC BAND Complications • Port site flippage and tubing injury • Can happen at anytime! • Difficult access to the gastric band fill port during band fill • The port is fixed to the rectus sheath, however, the sutures can give way or the port may get displaced with weight loss • Requires re-operative surgery to fix the port – cost implications! • Tubing injury occurs when accessing the port for band fill • Often occurs if multiple attempts are made • The failure to fill band or remove fluid suggests a leak. • Investigated by fluoroscopic imaging • Tubing may need cutting back – cost implications

  17. GASTRIC BAND Complications • Port site infection • Common complication (5%) • Pain, swelling, and redness around the access port • Due to band fills ? Technique ? Infected fluid ? Bad luck • Antibiotics vs removal of the port (urgent) • Can lead to infection of the band if left untreated or delayed management • Several cases of how the tubing is managed after the port is removed! • Laparoscopic approach versus open approach • Returning the cut end of the tubing back into the abdomen • Both acceptable as long as all necessary and reasonable steps have been taken • Advise patient of risk of ascending infection • Discuss band removal in entirety and consequences • Ensure that the tubing left behind is not infected – Samples for Microbiology • Chase up Microbiology and act accordingly

  18. The Gastric Band is removed – Hooray! Persistent abdominal pain after band removal….. Fragments of tubing may be left behind Sepsis can lead to fragmentation of the tube The tubing can snap as you pull it out Issues: - Was it a recognisable component of the gastric band apparatus - Did the Surgeon check the port site and band components removed - If a section of the tubing fractures off, this may not be seen or easily accounted for Often such fragments are seen on X-rays and cross-sectional imaging.

  19. Typical Client • Pt X 36yr old female, BMI 36 with mild back pain • Considered a gastric band and contacted a well advertised national private service to have a band fitted • Contacted by “advisor” who decided she was suitable for a band • Requested to pay the fee to secure date for surgery. Information to be sent through the post • Attended for surgery and consented on the day • Had a gastric band placement. Uncomplicated procedure and discharged February 2013 • Attended the first two follow-ups and then DNA’d further appointments

  20. Patient X • March 2016 (3 years) later developed heartburn and upper abdominal pain • GP prescribed antacid medication • June 2016 she continues to have epigastric pain and occasional vomiting. GP referred to A&E • A&E assessment: Mild abdo pain, likely band related. AXRay and CXRay normal. No perforation. Bloods normal. Discharged with advice • August 2016 A&E attendance with upper GI bleeding and sepsis • Underwent urgent laparotomy after a CT confirmed a perforated stomach • Laparotomy: Total gastrectomy and splenectomy

  21. Issues • Advice provided – Who, What and How? • Discussion of alternative procedures • Consent • Risks of surgery • Expectations – Expected weight loss. No weight loss • Medium & long term complications • Band slippage, erosion, infection • Port flippage, port infection, needling injury to band tubing • Weight regain Often patients are not informed that if a band has been placed in the private sector, revisional surgery or follow-up will not be accepted in the NHS The NHS will however manage patients as an emergency – band or port removal, but not replacement.

  22. Issues – Pt X • Was the laparotomy avoidable? • Did the GP make the right call in March 2016 • Was she appropriately managed by A&E in July 2016 The GP should have considered a gastric band related complication and referred her to an NHS Bariatric Unit – referral to A&E was however appropriate in July 2016. [I would ofcourse naturally defer any such opinion to an Expert in A&E Medicine!] A&E attendance: - The clinical history suggested a band related problem: Vomiting, weight regain, epigastric pain - The abdominal X-ray showed a classical sign pathognomic of band slippage - There was a failure of the patient to be referred for a General Surgical review - The band would have been deflated and the patient referred to a Bariatric or Upper GI Surgeon - The band would have been removed within 2 to 4 weeks On the balance of probability the emergency attendance and the need for laparotomy would not have occurred.

  23. SLEEVE GASTRECTOMY • Perhaps the most commonly performed bariatric procedure in the World Complications include: • Leaks [early (90% within 48 hours) and late (after 5 days)] • Bleeding • Strictures • Weight regain • Intolerance –pain, vomiting • Patients are discharged within 24 to 48 hours of surgery

  24. Issues on BOD - LSG • Informed Consent • Increased risk of reflux – pre-existing GERD? • Failure to lose weight – sleeve too wide? • Inability to swallow – sleeve too narrow or stricture? • Strictures – more common after leaks • Splenic injury / splenectomy – Bleeding • Operative technique • Revision surgery higher risk of complications • Was the sleeve calibrated – Bougie used? • Was a leak test undertaken – Methylene blue / air insufflation Failure to detect leak • Early discharge – NPSA guidelines – common symptoms vsatypia • Tachycardia, high opiate usage, inability to swallow liquids, pyrexia • Delayed management – weak evidence base, complex issues

  25. Gastroesophageal reflux disease (GERD)Antireflux surgery

  26. Issues of BOD – antireflux surgery • Did I need the operation? • Was the surgery performed to a reasonable standard? • Did I have something else wrong with me, as the operation has made we worse? • I cant swallow: the wrap was too tight • I still have reflux: the wrap was too loose • Vagal Nerve Injury, Post-vagotomy syndrome, Vagal Nerve entrapment

  27. Definition of GERD Vakil N, et al. Am J Gastroenterol 2006;101:1900 • Montreal consensus panel (44 experts): “a condition which develops when the reflux of stomach contents causes troublesome symptoms and/or complications” • Troublesome—patient gets to decide when reflux interferes with lifestyle

  28. Clinical presentation • Atypical symptoms (20-25%) • Cough • Asthma • Hoarseness • Non-cardiac chest pain • Heartburn • 1-2 hours after eating, often at night, antacid relief • Regurgitation • Spontaneous return of gastric contents proximal to GE jxn; less well relieved with antacids • Dysphagia (40%)—difficulty with swallowing should prompt search for pathologic condition

  29. What causes reflux? • Normal mechanisms preventing reflux • Upright posture • Anatomical: Intact crura / LES, Angulation of distal oesophagus, intra-abdominal oesophagus • Intra-thoracic pressure > abdominal pressure • Normal oesophageal motility (food pushed down) • Normal stomach emptying • LES dysfunction / laxity • Hiatus hernia • Weakness in the crura • Short oesophagus • Obesity • Hyper acidity • Gastric dysmotility

  30. EpidemiologyHiatal Hernias • Herniation of the stomach through the oesophageal hiatus: 30% of the adult population • Asymptomatic in the vast majority • 70% of patients with GERD have a hiatus hernia • The presence of a hiatal hernia is not an indication in itself for surgery

  31. What role does a hiatal hernia play? < 3 cm > 3 cm Greater gastric dilatation is necessary to open LES in patients with intact angle of HIS compared to those with a hiatal hernia Reflux occurs easier

  32. Sliding Hiatal Hernia • Type I • GE junction “slides” into the mediastinum • Most HH • May be associated with symptomatic GERD • Surgery not indicated

  33. What does my body do to compensate for reflux esophagitis? • Compensation: • Increased swallowing  saliva bathes injured mucosa, alleviating discomfort • Results in aerophagia, bloating, and belching • Distention leads to further repetitive injury to the terminal squamous epithelium in distal esophagus

  34. Diagnosis • Diagnosis based on symptoms alone is correct in only 2/3 patients • Differential • Achalasia • Diffuse esophageal spasm • Other esophageal motility disorder • Cancer • Ulcer disease • Coronary artery disease

  35. Who needs an operation? Mainstay of treatment is proton pump inhibitors and lifestyle changes Need for continuous drug treatment or escalating dose of PPI Relatively young Financial burden Non-compliance with PPI Patient choice

  36. How do you know I’m a candidate for surgery? Establish GERD as underlying cause of symptoms Estimate risk of progressive disease Determine presence or absence of esophageal shortening Evaluate esophageal body function

  37. What specific studies do I need preoperatively? • Endoscopy • Tumours, oesophagitis, hiatus hernia, short oesophagusetc • 24-hour ambulatory pH monitoring • Measures the amount of time the oesophagus is exposed to acid • Correlates acid exposure to symptoms • Fluoroscopy – contrast study • Assess oeosphageal motility, volume reflux, regurgitation • Esophageal body and gastric function • Oesophageal motility, gastric motility / emptying (pump) • Not all necessary! • Depends on pathology, symptoms and response to Rx

  38. Am I a candidate for surgery? J GastrointestSurg 1999;3:292-300 • Factors predictive of successful outcome following antireflux surgery (n = 199) • Abnormal score on 24-hour esophageal pH monitoring (p < 0.001) • Presence of typical symptoms of GERD (heartburn and regurgitation) (p< 0.001) • Symptomatic improvement in response to acid suppressive therapy (p = 0.02)

  39. Preoperative evaluation: 24-hour pH monitoring Correlates esophageal acid exposure with patients symptoms Without abnormal pH study, surgery is unlikely to benefit Gives a composite score (Johnson-DeMeester score) highly sensitive and specific (>96%) for diagnosing GERD

  40. Operative Technique & Principles of Surgery

  41. Hiatal hernia Left crus Right crus Diaphragm Stomach Liver Oesophagus

  42. Operative procedures • The most common anti-reflux operation is the laparoscopic fundoplication • Crural dissection, • Identification and preservation of both vagi • Circumferential dissection of oesophagus and establishing a good length of intra-abdominal oesophagus • Elements of fundoplication • Crural closure (cruroplasty) • Fundic mobilization by division of short gastrics • Creation of short, loose fundoplication by enveloping anterior and posterior wall around lower esophagus

  43. That operation looks nice, are people satisfied with it? Surgeon, August 2009:224. • Patient satisfaction is high (86-97%) • Long-term symptom relief (heartburn and regurgitation) in 84-97% • Symptomatic failure rate 3-13% • heartburn and regurgitation • Does not correlate with acidic reflux exposure • OPERATION DID NOTHING for 3-13%!

  44. What are the real bad things that can happen to me? JACS 2001: 193(4); 428-39 • Review of 10,489 laparoscopic antireflux procedures • Complications • Wrap herniation (early) 1.3% • Pneumothorax 1.0% • All others < 1% (perforation, hemorrhage, pneumonia, abscess, splenic injury, trocar hernia, effusion, PE, ulcer, atelectasis, wound infection, MI, splenectomy)

  45. How will I feel several months later? JACS 2001: 193(4); 428-39 Surgeon, August 2009:224. • Use of acid-suppressive medication after anti-reflux surgery varies (21-62%) • But, only 20-30% with “reflux-like” symptoms after surgery have positive pH studies JACS 2007;205:570 • Early dysphagia - usually transient (<6 weeks) • Persistent side effects (>1 month) • Bloating 9%, Reflux 4%, Dysphagia 3% Often poorly defined

  46. What does all of this mean, should I have surgery or not? RCT - Brit J Surg 2007;94:198. Gastroenterology 2008;135:1392. Surgery wins over PPI’s if you don’t mind trading heartburn and reflux for bloating, inability to belch, and excessive flatulence Not in everybody, BUT IT COULD BE YOU! Nevertheless, 86-97% of patients are satisfied with surgery

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