Establishing Laparoscopic Sleeve Gastrectomy as a Standard Procedure at a Swedish Bariatric Center
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Umeå University
- Enrollment
- 1,015
- Locations
- 1
- Primary Endpoint
- Weight loss
Study Overview
Brief Summary
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
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.
Study Design
- Study Type
- Observational
- Observational Model
- Case Control
- Time Perspective
- Retrospective
Eligibility Criteria
- Ages
- 18 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Weight loss
Time Frame: after 2 years
weight and height will be combined to report various measurements of BMI in kg/m\^2
Changes in Hypercholesterolemia (LDL-C > 3.0 mmol/L and/or HDL-C < 1.0 mmol/L).
Time Frame: after 2 years
Measured as Hypercholesterolemia (Plasma concentration of LDL \>3.0 mmol/L and/or of HDL \< 1.0 mmol/L).
Duration of surgery
Time Frame: From the start of the operation until completion, in average 62 minutes
Operation time in minutes
Duration of hospital stay
Time Frame: From time of operation until discharge, in average 1.7 days
Duration of hospital stay in days
Changes in hypertriglyceridemia (plasma-level >1.7 mmol/l)
Time Frame: after 2 year
measured as hypertriglyceridaemia (plasma-level \>1.7 mmol/l)
Late complications
Time Frame: From six weeks until 2 years from operation
Complications occurred from six weeks until 2 years from operation
Late reoperations
Time Frame: From six weeks until 2 years from operation
Reoperations occurred from six weeks until 2 years from operation
Changes in Diabetes
Time Frame: after 2 years
measured as fasting plasma glucose and/or Hemoglobin A1c
Early complications
Time Frame: At six weeks
Complications occurred until six weeks from operation
Changes in Hypertension
Time Frame: after 2 years
measured as Systolic- and Diastolic Blood Pressure
Early reoperations
Time Frame: At six weeks
Reoperations occurred until six weeks from operation
Secondary Outcomes
No secondary outcomes reported