Obesity, Morbid
Conditions
Keywords
Sleeve gastrectomy, banded sleeve, obesity surgery
Brief summary
Weight regain after Laparoscopic Sleeve Gastrectomy (LSG) is nowadays a growing concern. Sleeve dilatation and loss of food restriction is considered the main mechanism. The placement of a silicon ring around the gastric tube seems to give benefits in the short-term. The Investigators evaluate the efficacy of banded sleeve gastrectomy compared to standard sleeve in the mid-term. Fifty patients were randomized between LSG and Laparoscopic Banded Sleeve Gastrectomy (LBSG), and they underwent a mean follow-up of 4 years. Patients' management was exactly the same, apart from the band placement. After surgery differences in weight loss, operative time, complication rate and mortality were analyzed.
Interventions
PROCEDUREsleeve gastrectomy
Comparison of banded and not-banded sleeve gastrectomy
Sponsors
University of Rome Tor Vergata
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Morbid obesity * Failure of medical treatment * \>18yrs; \<60 yrs
Exclusion criteria
* Previous bariatric or GI surgery * Psychiatric disease * Pregnancy * Contraindication to laparoscopy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| weight loss | from surgery to 4 years follow up | comparison of weight loss between the two procedures |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complications | from surgery to 4 years follow up | Short and mid-term complications |
Countries
Italy
Outcome results
None listed