Sleeve Gastrectomy as a Standard Bariatric Procedure

Study Overview
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Brief Summary
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This study compared differences in weight loss, comorbidity resolution and complications and reoperations between a recently established sleeve gastrectomy (SG) and prior laparoscopic Rox-en-Y gastric bypass (RYGB).

Detailed Description
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This retrospective study with prospectively collected registry data presents results from establishment of SG as standard procedure for morbid obesity. Our first 368 patients operated with a SG were compared to 647 patients previously operated with a (RYGB. Perioperative data and results up to 2 years postoperatively regarding weight control, metabolic control as well as complications/reoperations necessary were registered. In summary, a RYGB was associated with a longer operation time and higher rates of late complications and reoperations. Diabetes resolution was similar in both groups but patients with a RYGB had greater weight loss and significant improvement in hypertension and dyslipidemias.

Official Title
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Establishing Laparoscopic Sleeve Gastrectomy as a Standard Procedure at a Swedish Bariatric Center

Conditions
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Postoperative Complications

Intervention / Treatment
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* Procedure: SG or a RYGB


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with either a BMI 35 or higher with comorbidity, or patients with a BMI of 40 or more without known comorbidity associated, undergoing a primary laparoscopic bariatric surgery in Sundsvall,Sweden 2010-01-01 to 2018-06-10. Exclusion Criteria: All other patients undergoing a bariatric surgery during this time frame

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| laparoscopic sleeve gastrectomy (SG)<br>Patients operated on with a SG | Procedure: SG or a RYGB<br>* operation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive<br>|
| laparoscopic Roux-en-Y gastric bypass (RYGB)<br>patients operated on with aRYGB | Procedure: SG or a RYGB<br>* operation type differed between a partial gastrectomy (SG)or a combined restrictive/malabsorptive<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | weight and height will be combined to report various measurements of BMI in kg/m^2 | after 6 weeks | 
| Weight loss | weight and height will be combined to report various measurements of BMI in kg/m^2 | after 1 year | 
| Weight loss | weight and height will be combined to report various measurements of BMI in kg/m^2 | after 2 years | 
| Changes in Diabetes | measured as fasting plasma glucose and/or Hemoglobin A1c | after 1 year | 
| Changes in Diabetes | measured as fasting plasma glucose and/or Hemoglobin A1c | after 2 years | 
| Changes in Hypertension | measured as Systolic- and Diastolic Blood Pressure | after 1 year | 
| Changes in Hypertension | measured as Systolic- and Diastolic Blood Pressure | after 2 years | 
| Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l) | measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l) | after 1 year | 
| Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l) | measured as hypertriglyceridaemia (plasma-level >1.7 mmol/l) | after 2 year | 
| Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L). | Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L). | after 1 years | 
| Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L). | Measured as Hypercholesterolemia (Plasma concentration of LDL >3.0 mmol/L and/or of HDL < 1.0 mmol/L). | after 2 years | 
| Duration of surgery | Operation time in minutes | From the start of the operation until completion, in average 62 minutes | 
| Duration of hospital stay | Duration of hospital stay in days | From time of operation until discharge, in average 1.7 days | 
| Early complications | Complications occurred until six weeks from operation | At six weeks | 
| Early reoperations | Reoperations occurred until six weeks from operation | At six weeks | 
| Late complications | Complications occurred from six weeks until 2 years from operation | From six weeks until 2 years from operation | 
| Late reoperations | Reoperations occurred from six weeks until 2 years from operation | From six weeks until 2 years from operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bariatric surgery, laparoscopic Roux-en-Y gastric bypass, laparoscopic sleeve gastrectomy, Morbid obesity, Weight loss, Metabolic control, Metabolic syndrome, Complication risk