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| Name | Class |
|---|---|
| Mudanya University | OTHER |
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Obesity is a growing global public health problem, and bariatric surgery is currently the most effective treatment for achieving sustained weight loss and improving obesity-related comorbidities. However, a subset of patients experience inadequate weight loss or weight regain following primary bariatric surgery, which may lead to the recurrence of metabolic complications and reduced quality of life. In such cases, conversion bariatric surgery, defined as the surgical conversion from one bariatric procedure to another, is considered an important therapeutic option. Despite the increasing number of conversion procedures, comprehensive longitudinal data evaluating anthropometric, biochemical, and nutritional outcomes after conversion bariatric surgery remain limited.
This study aims to prospectively evaluate individuals undergoing conversion bariatric surgery due to weight regain following primary bariatric surgery. Anthropometric measurements, biochemical parameters, and nutritional status will be assessed preoperatively and at 1 year after surgery. By evaluating weight loss outcomes together with metabolic and nutritional changes, this study seeks to provide clinically relevant evidence to guide postoperative follow-up strategies, optimize nutritional management, and support multidisciplinary care in patients undergoing conversion bariatric surgery.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conversion Bariatric Surgery | This cohort includes patients who previously underwent conversion bariatric surgery as part of routine clinical care and were followed observationally. Anthropometric measurements, biochemical parameters, and nutritional status were assessed at the preoperative period and postoperative month 12 (1 year). |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Body Composition Parameters | Body composition parameters including fat mass, fat percentage, fat-free mass, fat-free mass percentage, skeletal muscle mass, muscle percentage, and extracellular water to total body water ratio assessed using multi-frequency bioelectrical impedance analysis (BIA). | Preoperative baseline and postoperative 1 year |
| Change in Body Weight | Change in body weight (kg) measured using a digital scale with participants wearing light clothing and no shoes. | Preoperative baseline and postoperative 1 year |
| Change in Body Mass Index (BMI) | Change in body mass index (kg/m²) calculated from measured body weight and height. | Preoperative baseline and postoperative 1 year |
| Percentage of Total Weight Loss | Percentage of total weight loss calculated as [(preoperative weight - postoperative weight) / preoperative weight] × 100. | postoperative 1 year |
| Percentage of Excess Weight Loss | Percentage of excess weight loss calculated as [(preoperative weight - postoperative weight) / (preoperative weight - ideal body weight)] × 100, with ideal body weight defined as a BMI of 25 kg/m². | postoperative 1 year |
| Change in Waist Circumference | Waist circumference (cm) measured in the standing position using a non-elastic measuring tape at the midpoint between the lowest rib and the iliac crest. | Preoperative baseline and postoperative 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Fasting Plasma Glucose | Changes in fasting plasma glucose levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Alanine Aminotransferase (ALT) |
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Inclusion Criteria:
Suboptimal clinical response defined as either:
Exclusion Criteria:
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Adult patients aged 18-65 years who had previously undergone bariatric surgery and subsequently received conversion bariatric surgery due to suboptimal clinical response, defined as suboptimal weight loss or recurrent weight gain. Participants are followed in routine clinical practice and evaluated preoperatively and at postoperative 1 year for anthropometric, biochemical, nutritional, and physical activity outcomes.
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| Name | Affiliation | Role |
|---|---|---|
| Seher Åžen, Assistant Professor | Mudanya University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mudanya Univesity | Osmangazi | Bursa | 16160 | Turkey (Türkiye) |
Individual participant data will not be shared due to the need to protect patient privacy and confidentiality.
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Change in Hip Circumference | Hip circumference (cm) measured in the standing position at the point of maximum protrusion of the gluteal muscles using a non-elastic measuring tape. | Preoperative baseline and postoperative 1 year |
| Change in Body Fat Percentage (%) | Body fat percentage measured using multi-frequency bioelectrical impedance analysis (BIA). | Preoperative baseline and postoperative 1 year |
| Change in Fat-Free Mass (kg) | Fat-free mass measured using multi-frequency bioelectrical impedance analysis (BIA). | Preoperative baseline and postoperative 1 year |
| Change in Skeletal Muscle Mass (kg) | Skeletal muscle mass measured using multi-frequency bioelectrical impedance analysis (BIA). | Preoperative baseline and postoperative 1 year |
Changes in alanine aminotransferase (ALT) levels measured from venous blood samples.
| Preoperative baseline and postoperative 1 year |
| Change in Hematological Parameters | Changes in hemoglobin and hematocrit levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Iron Status Parameters | Changes in serum ferritin, serum iron, and total iron-binding capacity levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Micronutrient and Electrolyte Levels | Changes in serum vitamin B12, folic acid, magnesium, total calcium, sodium, and potassium levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Fasting Insulin | Changes in fasting insulin levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Glycated Hemoglobin (HbA1c) | Changes in glycated hemoglobin (HbA1c) levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Total Cholesterol | Changes in total cholesterol levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in LDL Cholesterol | Changes in low-density lipoprotein (LDL) cholesterol levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in HDL Cholesterol | Changes in high-density lipoprotein (HDL) cholesterol levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Triglyceride Levels | Changes in triglyceride levels measured from venous blood samples | Preoperative baseline and postoperative 1 year |
| Change in Aspartate Aminotransferase (AST) | Changes in aspartate aminotransferase (AST) levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Urea Levels | Changes in serum urea levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| Change in Uric Acid Levels | Changes in serum uric acid levels measured from venous blood samples. | Preoperative baseline and postoperative 1 year |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |