Morbid Obesity
Conditions
Brief summary
This is a prospective case series study; all morbidly obese patients that need surgical management in Royal Alexandra Hospital will be provided 3 surgical options: Laparoscopic Sleeve Gastrectomy (LSG), laparoscopic Roux-en-Y gastric bypass (LR-en-Y), and laparoscopic gastric banding (LGB), safety and effectiveness will be compared among the 3 groups. The outcome measures will be percentage of excess weight loss, BMI, operative time, hospital stays, complications and improvement of comorbidities.
Interventions
None listed
Sponsors
Alberta Health services
University of Alberta
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* morbid obese patients aged from 18-65, * BMI \> 40 kg/m2 or BMI\> 35 kg/m2 with severe comorbidities: diabetes, sleep apnea, hypertension etc.
Exclusion criteria
* psychiatric illness, * substance abuse, * previous gastrointestinal surgery, and * any patient who transfers from laparoscopic to convention procedure.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Body Weight | baseline to 2-year postoperation | Change of body weight in Kilograms measured at follow-up visits two year after surgery |
| Change in BMI | from baseline to 2-year postoperation | Patients' weight and height were measured at follow up visit 2 years post operation. BMI was calculated using the formula: weight (kg)/height(meter)\^2 |
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| LSG (Lap SG) Laparoscopic Sleeve Gastrectomy | 51 |
| LRYGB Laparoscopic Roux-en-Y Gastric Bypass | 51 |
| LAGB Laparoscopic Adjustable Gastric Banding | 48 |
| Total | 150 |
Baseline characteristics
| Characteristic | LSG (Lap SG) | LRYGB | LAGB | Total |
|---|---|---|---|---|
| Age, Continuous | 45.4 years STANDARD_DEVIATION 9.6 | 41.9 years STANDARD_DEVIATION 8.4 | 43.1 years STANDARD_DEVIATION 10.3 | 43.5 years STANDARD_DEVIATION 9.5 |
| Race/Ethnicity, Customized race other race | 5 Participants | 0 Participants | 4 Participants | 9 Participants |
| Race/Ethnicity, Customized race white race | 46 Participants | 51 Participants | 44 Participants | 141 Participants |
| Sex: Female, Male Female | 45 Participants | 41 Participants | 45 Participants | 131 Participants |
| Sex: Female, Male Male | 6 Participants | 10 Participants | 3 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 0 | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 5 / 51 | 10 / 51 | 7 / 48 |
Outcome results
Primary
Change in BMI
Patients' weight and height were measured at follow up visit 2 years post operation. BMI was calculated using the formula: weight (kg)/height(meter)\^2
Time frame: from baseline to 2-year postoperation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Change in BMI | -7.6 kg/m^2 | Standard Deviation 5.7 |
| Laparoscopic Roux-en-Y Gastric Bypass | Change in BMI | -13.0 kg/m^2 | Standard Deviation 6.6 |
| Laparoscopic Adjustable Gastric Banding | Change in BMI | -2.6 kg/m^2 | Standard Deviation 3.5 |
Primary
Change in Body Weight
Change of body weight in Kilograms measured at follow-up visits two year after surgery
Time frame: baseline to 2-year postoperation
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Laparoscopic Sleeve Gastrectomy | Change in Body Weight | -21.4 kg | Standard Deviation 16 |
| Laparoscopic Roux-en-Y Gastric Bypass | Change in Body Weight | -36.6 kg | Standard Deviation 19.5 |
| Laparoscopic Adjustable Gastric Banding | Change in Body Weight | -7.0 kg | Standard Deviation 9.7 |