Bougie Diameter on Outcomes in Laparoscopic Sleeve Gastrectomy

This validated instrument specifically designed for bariatric surgery patients evaluates six domains of quality of life:

1. Self-Esteem: Assessment of patient's self-perception and confidence levels
2. Physical Activity: Evaluation of exercise capacity and physical function
3. Social Contacts: Assessment of social interactions and relationships
4. Work Performance: Evaluation of occupational capacity and productivity
5. Sexual Interest: Assessment of sexual function and interest
6. Eating Behavior: Evaluation of eating patterns and food-related behaviors

Each domain is scored from -3 to +3 points, with total MA-II Score Range: -18 to +18 points.

Score interpretation:

• Very poor quality of life: -18 to -9 points
• Poor quality of life: -8 to -3 points
• Fair quality of life: -2 to +2 points
• Good quality of life: +3 to +8 points
• Very good quality of life: +9 to +18 points

The questionnaire evaluates:

1. Overall Satisfaction with Food Intake (0-3 points):

• 0 = Cannot eat normal food
• 1 = Eats small amounts of normal food
• 2 = Eats normal food with some restrictions
• 3 = Eats normal food without restrictions

1. Food Tolerance Score (0-24 points): Assessment of tolerance to 8 food categories:

• Meat
• Salad/raw vegetables
• Fresh fruits
• Bread
• Rice/pasta
• Vegetables
• Dairy products
• Liquids Each food scored 0-3 points:
• 0 = Cannot eat at all
• 1 = Can eat small amounts with difficulty
• 2 = Can eat moderate amounts with some difficulty
• 3 = Can eat normal amounts without difficulty

1. Eating Behavior Assessment:

• Eating frequency per day
• Time required for meals
• Chewing adequacy
• Presence of food aversion

Total Suter Score Range: 0-27 points

• Excellent tolerance: 24-27 points
• Good tolerance: 21-23 points
• Fair tolerance: 18-20 points
• Poor tolerance: <18 points

Calculation Formula: %TWL = [(Initial weight - Current weight) / Initial weight] × 100 (weight is measured in kilograms Kg)

Success Criteria according to Eisenberg et al.:

• Adequate weight loss: ≥20% TWL at 12 months
• Good weight loss: ≥25% TWL at 12 months
• Excellent weight loss: ≥30% TWL at 12 months

Assessment Tool: Modified Postoperative Nausea and Vomiting (PONV) Scale according to Apfel et al.

Nausea Assessment (0-10 scale):

• 0 = No nausea
• 1-3 = Mild nausea
• 4-6 = Moderate nausea
• 7-10 = Severe nausea

Vomiting Assessment:

• Number of vomiting episodes per 24-hour period
• Volume of vomitus (estimated) (Volume is measured in milliliters mL)
• Character of vomitus (bilious, food particles, blood)

Antiemetic Usage:

• Antiemetic administered
• Dosage and frequency
• Time to administration
• Effectiveness assessment

VAS Pain Scale: 100mm horizontal line with anchors according to Hawker et al.

• 0mm = "No pain"
• 100mm = "Worst possible pain"

Pain Categories:

• No pain: 0-4mm
• Mild pain: 5-44mm
• Moderate pain: 45-74mm
• Severe pain: 75-100mm

Additional Pain Assessments:

• Location of pain (incisional, abdominal, shoulder)
• Pain character (sharp, dull, cramping)
• Pain interference with activities
• Analgesic requirements and effectiveness

Measurement Parameters:

• Admission time: Date and time of hospital admission
• Surgery time: Date and time of procedure completion
• Discharge time: Date and time of hospital discharge
• Total length of stay: Hours from admission to discharge
• Postoperative length of stay: Hours from surgery completion to discharge
• Need for re-admission

Discharge Criteria:

• Stable vital signs for 6 hours
• Adequate pain control with oral medications
• Tolerance of clear liquids without nausea/vomiting
• Ambulation without assistance
• No signs of complications
• Patient understanding of discharge instructions

All complications within 30 days will be classified using the Clavien-Dindo system Grade I: Any deviation from normal postoperative course without need for pharmacological, surgical, endoscopic, or radiological interventions

Grade II: Requiring pharmacological treatment with drugs other than allowed for Grade I complications

Grade III: Requiring surgical, endoscopic, or radiological intervention

• Grade IIIa: Intervention not under general anesthesia
• Grade IIIb: Intervention under general anesthesia

Grade IV: Life-threatening complications requiring intensive care management

• Grade IVa: Single organ dysfunction
• Grade IVb: Multi-organ dysfunction

Grade V: Death of patient

Suffix "d": Added if patient suffers from complication at discharge (e.g., Grade IIId)

The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies.

Type 2 Diabetes Mellitus:

• Complete remission: HbA1c <6.0% without antidiabetic medications for ≥1 year
• Partial remission: HbA1c 6.0-6.4% without antidiabetic medications for ≥1 year
• Improvement: Reduction in HbA1c ≥1% or reduction in antidiabetic medications
• No change: <1% change in HbA1c and same medications
• Worsening: Increase in HbA1c or need for additional medications

The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies.

Arterial Hypertension:

• Resolution: Blood pressure <140/90 mmHg without antihypertensive medications
• Improvement: Reduction in number or dosage of antihypertensive medications
• No change: Same blood pressure control with same medications
• Worsening: Need for additional medications or poor control

The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies.

Dyslipidemia:

• Resolution: Normal lipid profile without lipid-lowering medications
• Improvement: Improvement in lipid parameters or reduction in medications
• No change: Stable lipid profile with same medications
• Worsening: Deterioration in lipids or need for additional medications

The evaluation of comorbidity resolution and improvement will be conducted according to the standardized outcomes reporting criteria established by the American Society for Metabolic and Bariatric Surgery (ASMBS) Clinical Issues Committee, as published by Brethauer et al. This standardized approach ensures consistency with current best practices and facilitates comparison with other bariatric surgery studies.

Obstructive Sleep Apnea:

• Resolution: Normal sleep study without CPAP therapy
• Improvement: Reduced AHI or decreased CPAP pressure requirements
• No change: Stable sleep study parameters
• Worsening: Increased AHI or higher CPAP pressure requirements

Mandatory 1-Year Upper GI Assessment:

1. Upper Gastrointestinal Endoscopy:

• Systematic evaluation of esophagus, gastroesophageal junction, and gastric sleeve
• Los Angeles (LA) Classification reassessment for reflux esophagitis

1. GERD Symptom Reassessment:

• GERD-Q questionnaire readministration
• Arabic GERD-Q questionnaire for Arabic-speaking patients
• Comparison with preoperative GERD-Q scores
• Documentation of PPI usage changes from baseline
• Assessment of new or worsening reflux symptoms
• Evaluation of extraesophageal symptoms

1. Upper GI Outcome Classification:

• Improved: Reduction in GERD-Q score ≥2 points from baseline and/or improvement in LA grade
• Stable: GERD-Q score change <2 points and stable LA grade
• Worsened: Increase in GERD-Q score ≥2 points and/or progression in LA grade
• New-onset GERD: Development of GERD-Q score >8 in previously asymptomatic patients

Baseline Assessment

• Complete blood count (CBC)

Normal ranges for a Complete Blood Count (CBC) vary by age, sex, and even the laboratory performing the test, but generally, adult normal ranges include:

• Red Blood Cell Count (RBC): ~4.2-6.1 million cells/mcL (in number of cells per microliter)
• White Blood Cell Count (WBC): ~4,500-11,000 cells/mcL (in number of cells per microliter)
• Hemoglobin: ~12-18 g/dL (in grams per deciliter)
• Platelets: ~150,000-450,000/mcL (in number of cells per microliter)

Baseline Assessment:

• Comprehensive metabolic panel Normal ranges for a comprehensive metabolic panel (CMP) can vary by laboratory, but generally include values for glucose (70-100 mg/dL), calcium (8.5-10.2 mg/dL), blood urea nitrogen (BUN) (6-20 mg/dL), and creatinine (0.6-1.3 mg/dL). The CMP also includes liver function tests such as albumin (3.4-5.4 g/dL), total protein (6.0-8.3 g/dL), alkaline phosphatase (20-130 U/L), ALT (4-36 U/L), AST (8-33 U/L), and total bilirubin (0.1-1.2 mg/dL). (measured in Grams or milligrams per deciliter)

Baseline Assessment:

• Lipid profile Normal lipid profile levels in mg/dL for adults are generally Total Cholesterol below 200, LDL (bad) Cholesterol below 100, HDL (good) Cholesterol 40 or higher for men and 50 or higher for women, and Triglycerides below 150.

Baseline Assessment:

• Hemoglobin A1c A normal HbA1c range is generally considered below 5.7%, which indicates healthy blood sugar levels. The ranges for prediabetes and diabetes are 5.7% to 6.4% and 6.5% or higher, respectively. These results reflect average blood sugar levels over the past 2-3 months and are used to monitor, screen, and diagnose diabetes and prediabetes.

Baseline Assessment:

• Thyroid function tests (free T4) Normal thyroid function test values vary by lab, age, and pregnancy status, but a typical range for adults is 9.0-25.0 pmol/L for free T4. (measured in picomoles per liter)

Baseline Assessment: - Thyroid function tests (Serum TSH) Normal thyroid function test values vary by lab, age, and pregnancy status, but a typical range for adults is 0.4-4.0 mIU/L for TSH. (measured in milli international unit per liter)

Baseline Assessment:

• Vitamin B12 Normal values for serum vitamin B12 typically fall in the range of 180-914 pg/mL. (measured in picograms per milliliter)

Baseline Assessment:

• Serum Folate Normal values for serum folate is around 4.0 ng/mL. (measured in nanograms per milliliter)

Baseline Assessment:

• 25-hydroxyvitamin D Normal values for a 25-hydroxyvitamin D test vary, but generally, sufficiency is considered to be 20-50 ng/mL (50-125 nmol/L). Levels below 20 ng/mL (50 nmol/L) may indicate insufficiency, while levels below 10 ng/mL (25 nmol/L) often signify deficiency.

Baseline Assessment:

• Iron studies (ferritin, transferrin saturation, TIBC) Serum Iron: Measures the amount of iron in the blood. Males: 50-150 mcg/dL (8.95-26.85 micromol/L) Females: 35-145 mcg/dL (6.26-25.95 micromol/L) Total Iron-Binding Capacity (TIBC): Measures the blood's ability to attach to iron.

General Range: 250-450 mcg/dL (45-81 micromol/L) Transferrin Saturation: The percentage of transferrin (a protein that carries iron) that is saturated with iron.

Males: 20-50% Females: 15-45% Ferritin: Measures the body's iron stores. Men: 30-300 ng/mL Women: 20-200 ng/mL

Baseline Assessment:

• Albumin and prealbumin Normal adult albumin levels are typically 3.5 to 5.5 g/dL, while normal adult prealbumin levels are usually 15 to 36 mg/dL.

Baseline Assessment:

• Parathyroid hormone (PTH) Normal parathyroid hormone (PTH) levels typically fall between 10 and 65 pg/mL.

Baseline Assessment:

• Calcium and phosphorus Normal serum calcium levels for adults are roughly 8.6-10.3 mg/dL, while normal phosphorus levels are approximately 2.5-4.5 mg/dL.

Baseline Assessment:

• Magnesium and zinc levels Normal magnesium levels are typically 1.7 to 2.2 mg/dL. Normal zinc levels, however, are more variable, with studies showing ranges such as 71.26-108.53 µg/dL in one population and 60.82-96.13 µg/dL in another.