American Society For Metabolic And Bariatric Surgery: Care .
1American Society for Metabolic and Bariatric Surgery:Care Pathway Development for Laparoscopic SleeveGastrectomy1
2Table of ContentsSubcommittee Chairs and Members . 7Statement of Purpose . 8Methodology . 8Search Strategy and Literature Review . 9Study Selection and Characterization of Articles . 9Quality Assessment and Data Analysis . 9PREOPERATIVE: ROUTINE . 17Preadmission Patient Information and Education: . 17Laboratory Studies: . 17Screening:. 17 Obstructive Sleep Apnea Screening: . 17 Malignancy Screening: . 17 Substance Use: . 17 Functional Status: . 18Diet: . 18Testing:. 18 Chest Radiography: . 18 Electrocardiogram: . 18Consultants: . 18 Nutrition Consult: . 18 Psychology Consult: . 18PREOPERATIVE: SELECTIVE . 19Laboratory Studies: . 19 H-Pylori: . 19 Urine Nicotine: . 19 Urine Toxicology Screen:. 19Testing:. 19 Endoscopy/Upper Gastrointestinal (UGI) series: . 19 Ph/manometry: . 202
3 Bone Density Test: . 20 Sleep Study:. 20 Colonoscopy: . 20 Ultrasound: . 20 Venous Ultrasound: . 20Consultations: Selective . 21 Anesthesia Consult: . 21 Cardiovascular Consult: . 21 Endocrinology Consult: . 21 Gastroenterology Consult: . 21 Hematology Consult: . 21 Nephrology Consult: . 21 Pain Management Consult:. 22 Pharmacist Consult: . 22 Pulmonary Specialist Consult: . 22 Sleep Medicine Consult: . 22PREOPERATIVE: NOT RECOMMENDED . 23 Mandatory Preoperative Weight Loss: . 23 Inferior Vena Cava (IVC) Filter Placement: . 23 Bowel Prep: . 23 Gastric Emptying Study: . 21INTRAOPERATIVE: ROUTINE . 27Venous Thromboembolism (VTE) Prophylaxis . 27 Sequential Compression Device: . 27 Chemoprophylaxis: . 27Antibiotics . 27 Antibiotics: . 27Patient Positioning . 27Bougie Size . 27Hiatal Inspection . 28 Hiatus Inspection: . 283
4Protective Specimen Retrieval . 28 Protective Specimen Retrieval: . 28INTRAOPERATIVE: Selective . 28Buttressing/Over Sewing Staple Line . 28 Buttressing/Over sewing staple line: . 28Leak Test . 28Endoscopy . 28 Endoscopy: . 28INTRAOPERATIVE: NOT RECOMMENDED . 28Routine Drains . 29 Nasogastric Tube/Closed Suction Abdominal Drain: . 29 Urinary Catheter: . 29 Central Venous Access:. 29 Arterial Line: . 29POSTOPERATIVE: ROUTINE . 32Prophylaxis . 32 Prophylaxis Postoperative Nausea and Vomiting:. 32 Prophylaxis Postoperative Venous Thromboembolism: . 33Monitoring . 33 Routine Postoperative Monitoring: . 33Multimodal Pain Management . 33 Postoperative Pain Management: . 33Length of Stay (1-2 nights) . 34 Anticipated Length of Stay:. 34Diet . 34 Diet: . 34Postoperative Visits . 35 Time to Postoperative Visit: . 35Postoperative Medications . 35 Postoperative Medications: . 35Early Ambulation . 354
5 Early Ambulation . 35POSTOPERATIVE: SELECTIVE . 36Monitoring . 36 Finger Stick Testing: . 36 Continuous Pulse Oximetry:. 36Medications . 36 Extended VTE Prophylaxis: . 36Consultants . 37 Nutrition: . 37 Physical Therapy: . Error! Bookmark not defined. Acute Pain Management: . 37 Cardiology: Selective . 37 Endocrine: . 37 Postoperative Upper GI: . 37References . 405
6List of TablesTable 1. Literature Search Strategy . 10Table 2. Overview of perioperative metrics investigated for inclusion in clinical care map . 13Table 3. 2010 American Association of Clinical Endocrinologists Protocol for Production ofClinical Practices Guidelines - Step I: Evidence Rating*. 14Table 4. American Association of Clinical Endocrinologists for Production of Clinical PracticeGuidelines - Step II: Evidence Analysis and Subjective Factors. 15Table 5. American Association to Clinical Endocrinologists Protocol for Production of ClinicalPractice Guidelines - Step III: Grading of Recommendations; How Different Evidence Levelscan be Mapped to the Same Grade* . 16Table 6. Summary of Preoperative Recommendations: Routine . 24Table 7. Summary of Preoperative Recommendations: Selective . 25Table 8. Summary of Preoperative Recommendations: Not Recommended. 26Table 9. Summary of Intraoperative Recommendations: Routine. 30Table 10. Summary of Intraoperative Recommendations: Selective. 30Table 11. Summary of Intraoperative Recommendations: Not Recommended . 31Table 12. Summary of Postoperative Recommendations: Routine . 38Table 13. Summary of Postoperative Recommendations: Selective . 396
7Subcommittee Chairs and MembersA working product of the Quality Improvement and Patient Safety (QIPS) CommitteeProject chair: Dana Telem MD, FASMBSProject Manager: Donna Watson, PhD, RN, CNOR, FNPSubcommittee chairs and members:Pre-operative:Chair: Kinga Powers MDGroup members: Lionel Brounts MD, Henry Lin MDIntra-operative:Chair: Carl Pesta DOGroup members: Anthony Petrick MD, Andre Teixeira MDPost-operative:Chair: Jon Gould MDGroup members: Jake Greenberg MD, Saniea Majid MD7
8Statement of PurposeClinical care maps are defined as tools that guide evidenced-based healthcare with the expressgoal of optimizing healthcare delivery and quality while minimizing health care costs. The goalof a clinical care map should be to accurately represent the care path for at least routine patientcare and ideally to also provide structure for patient care when an individual patient develops anissue that requires deviation from the routine treatment path. Such care maps have importantimplications as we transition to value based healthcare.(1, 2)The value of a care map is well recognized in bariatric surgery. Current literature, while limited,does support the use of clinical care pathways in bariatric surgery. Several single institutionalstudies of bariatric patients demonstrate reductions in cost, reduced hospital length of stays anddecreased rate of perioperative complications following implementation of standardized patientclinical pathways.(3-7) Maintenance of and adherence to clinical care pathways are alsomandated as a requirement for accreditation by The Metabolic and Bariatric SurgeryAccreditation and Quality Improvement Program (MBSAQIP).(8) Despite this recommendationa nationally accepted care map pertaining to bariatric surgery does not exit.The Quality Improvement and Patient Safety (QIPS) Committee supports the mission and valuesof the American Society of Metabolic and Bariatric Surgeons (ASMBS) by promotingcontinuous improvement in patient safety and risk reduction. These goals are achieved by theintegration and coordination of patient safety initiatives to reduce medical errors through processanalysis and participation in quality improvement reporting. This committee recognized theimportance of clinical care maps and that while mandated by MBSAQIP, little was known as tothe content and variability of such pathways on a national level. We hypothesized that collectingand sharing established successful pathways could ultimately provide a valuable resource tosupport new programs as well as help existing programs improve patient safety. Additionally,analyzing these pathways would also demonstrate the variability in practice patterns across thecountry.A study was then conducted which identified considerable national variations in clinicalpathways are demonstrated among practicing bariatric surgeons. Only 6 variables that wereassessed: preoperative nutritional evaluation, preoperative psychological evaluation, mention ofintraoperative venous thromboembolism prophylaxis, mention of antiemetic utilization in thepostoperative period, a dedicated perioperative pain and mention of obtainment of postoperativelaboratory values were concordant between pathways. Further evaluation of these pathways alsodemonstrated the majority of metrics, even when mentioned, to be nonspecific without clearrecommendation as to whether these metrics should be followed routinely versus selectively andin whom.(9)This study highlighted a key opportunity for the ASMBS to develop and implement an evidencebased national care map for sleeve gastrectomy. As such, a task force was initiated to create thiscare map.Methodology8
9Search Strategy and Literature ReviewSystematic literature reviews were identified by principle literature searches conducted utilizingEmbase or Pubmed to identify relevant contributions (Table 1). The Medical Subject Headings(MeSH) and text words were determined by the authors. Reference list of relevant manuscriptsand gray materials were reviewed at the discretion of assigned work groups (i.e., preoperative,intraoperative, and postoperative) to identify other relevant titles. Article title and abstracts werereviewed by work groups for inclusion or exclusion to determine the relevance of the literature tothe topic area. Irrelevant studies were excluded.Study Selection and Characterization of ArticlesRelevant manuscripts were selected by individual reviewers from manuscript titles and abstracts.Supporting evidence for each topic included randomized control studies, non-randomized controlstudies, meta-analysis, systemic reviews and reviews.Articles were characterized on the following topics related to predetermined preoperative,intraoperative, and postoperative metrics. Metrics to be included were decided upon by expertconsensus; common variables found in national pathways and MBSAQIP accreditationrequirements and are listed in Table 2.Quality Assessment and Data AnalysisThe methodological quality of the studies was assessed utilizing the 2010 American Associationof Clinical Endocrinologists Protocol for Production of Clinical Practice Guidelines: EvidenceRating (Table 3-5). Evidence quality and recommendation for clinical application wereevaluated according to evidence level and grading recommendations. The committee utilized aconsensus process when there was a lack of supporting evidence (Table 2 and 4). There aresome recommendations based on consensus due to limited evidence. The recommendations arecategorized as follows: “Routine” recommendation indicates the committee has confidence theevidence-based literature supports routine ordering of designated diagnostic studies, tests, andevaluations. “Selective” recommendation is indicated for patients with designated criteria tosupport additional practice, procedure, study, test or evaluation. “Not Recommended” areunnecessary practices, procedures, studies, tests, and/or evaluations and should not be routinelyconducted.9
10Table 1. Literature Search StrategyData BaseTime PeriodTopicMeSH HeadingsEmbase1948 – October2015Laparoscopic SleeveGastrectomy:Enhanced c SleeveGastrectomy:Preoperative Phase20bariatric NEAR/2 surg*OR sleeve NEAR/2bypass OR sleeveNEAR/2 gastrectomy ORgastric NEAR/2 bypassOR stomach NEAR/2bypassenhanced NEAR/2recover* NEAR/2 surg*OR eras239'laparoscopic sleevegastrectomy':ti OR'laparoscopic sleevegastrectomy':de AND'preoperative period'(preoperat* OR 'preoperative' OR presurg*OR 'pre surgical')NEAR/5 (test OR testsOR testing OR evaluat*OR screen* OR diet ORpreparation* OR 'x ray'OR 'x rays' OR 'mandatoryweight loss' ORendoscop* ORassessment* OR'helicobacter pylori' OR 'hpylori' OR nutrition)laparoscop* NEAR/3sleeve ic SleeveGastrectomy: DeepVein Thrombosisand AssessmentToolsResults28(dvt OR 'deep veinthrombosis' OR'pulmonary embolism' ORvte OR 'venousthromboembolism')NEAR/5 risk* NEAR/5(tool OR tools OR screen*10
11OR score* OR scale* ORassessment* OR evaluat*OR predict* OR diagnos*OR preoperative* ORwells OR caprini OR'university of michigan'OR 'north american')bariatric NEAR/2 surg*Pubmed2006-2016Laparoscopic Sleeve "laparoscopy"[MeSHGastrectomy: Bougie Terms] OR"laparoscopy"[All Fields]OR "laparoscopic"[AllFields]) AND sleeve[AllFields] AND("gastrectomy"[MeSHTerms] OR"gastrectomy"[AllFields])) AND bougie[AllFields] AND(hasabstract[text] AND"2006/06/21"[PDAT] :"2016/06/17"[PDAT])75Embase1948 – February2016Laparoscopic SleeveGastrectomy:Postoperative diet16#4#2 OR #32#3#1 AND (postsurg* OR'post surgery' OR 'postsurgical') NEAR/5 diet*14#2#1 AND postoperat*NEAR/5 diet*3,135#1laparoscop* NEAR/5sleeve opic SleeveGastrectomy:Antiemetic agents27#7#1 AND (#5 OR #6)2711
1287#6(antinausea* OR 'antinausea') NEAR/2(medicat* OR drug ORdrugs)168,676#5antiemetic* OR 'antiemeticagent'/exp16#4#2 OR #32#3#1 AND (postsurg* OR'post surgery' OR 'postsurgical') NEAR/5 diet*14#2#1 AND postoperat*NEAR/5 diet*3,135#1laparoscop* NEAR/5sleeve NEAR/5gastrectom*Record 112
13Table 2. Overview of perioperative metrics investigated for inclusion in clinical care map13
14Table 3. 2010 American Association of Clinical Endocrinologists Protocol for Production ofClinical Practices Guidelines - Step I: Evidence Rating*Numericaldescriptor(evidence level)11222233334Semantic descriptor(reference methodology)Meta-analysis of randomized controlled trials (MRCT)Randomized controlled trial (RCT)Meta-analysis of nonrandomized prospective or case-controlled trials(MNRCT)Nonrandomized controlled trial (NRCT)Prospective cohort study (PCS)Retrospective case-control study (RCCS)Cross-sectional study (CSS)Surveillance study (registries, surveys, epidemiologic study) (SS)Consecutive case series (CCS)Single case reports (SCR)No evidence (theory, opinion, consensus, or review) (NE)*1 strong evidence; 2 intermediate evidence; 3 weak evidence; 4 no evidence.14
15Table 4. American Association of Clinical Endocrinologists for Production of Clinical PracticeGuidelines - Step II: Evidence Analysis and Subjective FactorsStudy DesignPremise correctnessAllocation concealment(randomization)Selection biasAppropriate blindingUsing surrogate endpoints(especially in “first-in-its classintervention)Sample size (beta error)Null hypothesis versusBayesian statisticsData analysisIntent-to- treatAppropriatestatisticsInterpretation of ty15
16Table 5. 2010 American Association to Clinical Endocrinologists Protocol for Production ofClinical Practice Guidelines - Step III: Grading of Recommendations; How Different EvidenceLevels can be Mapped to the Same Recommended Grade*Best evidencelevel1221Subjective irectAdjust just ustDdown*Starting with the left column, best evidence levels (BEL), subjective factors, and consensusmap to recommendation grades in the right column. When subjective factors have little or noimpact (“none”), then the BEL is directly mapped to recommendation grades. When subjectivefactors have a strong impact, then recommendation grades may be adjusted up (“positive”impact) or down (“negative” impact). If a two-thirds consensus cannot be reached, then therecommendation grade is D. NA not applicable (regardless of the presence or absence of strongsubjective factors, the absence of a two-thirds consensus mandates a recommendation grade D).16
17PREOPERATIVE SLEEVE GASTRECTOMYPREOPERATIVE: ROUTINEPreadmission Patient Information and Education:Patient information and education play an essential role in setting expectations andmodifying individual response to surgical procedure. All patients should participate in abariatric surgery information session prior to decision for bariatric surgery that includesinformation on formal preparation and counseling expectations.(10) The initial bariatricsurgery informational session should include but is not limited to weight loss surgicaloptions, surgery risks and complications, nutritional requirements, pathway information,support group participation, follow-up and monitoring requirements. Clinic practiceguidelines exists describing detailed patient information and education.(11, 12)Laboratory Studies:Routine preoperative laboratory testing: Complete blood cell (CBC) count, basicmetabolic panel (Chem 7), liver function tests, albumin, hemoglobin A1c (Hg A1c),international normalized ratio (INR), prothrombin time (PT), partial thromboplastintime(PTT), thyroid-stimulating hormone (TSH), vitamin B1, vitamin B12, vitamin D,micronutrients, urinalysis, urine human chorionic gonadotropin (HCg) for females.(1114)Screening: Obstructive Sleep Apnea Screening:Routine screening for obstructive sleep apnea should be conducted. Patients with clinicalsymptoms or positive screening should be referred for polysomnography.(12, 15, 16) Malignancy Screening:All patients should be encouraged to have routine cancer screening by a primary careprovider based on age and risk factors. These screening tests should be done according tothe current national guidelines. Although we recommend all patients be up to date withthe screening recommendations, this does not preclude them from undergoing bariatricsurgery unless patient are symptomatic or other factors indicate these test to be no longerscreening in nature. (17) Substance Use:Assess patient history or active substance use to include nicotine (cigarettes, cigars, pipe,snuff/chew, hookah, electronic nicotine delivery devices, and nicotine replacementtherapy), alcohol, caffeine, and medications.(18) All patients should be advised to stopsmoking. Smoking cessation and duration of cessation demonstrated prior to surgeryshould be at the discretio
The value of a care map is well recognized in bariatric surgery. Current literature, while limited, does support the use of clinical care pathways in bariatric surgery. Several single institutional studies of bariatric patients demonstrate
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