Morbid Obesity
Conditions
Keywords
Morbid obesity, Obesity surgery, Gastric bypass, Banded gastric bypass
Brief summary
The purpose of the study is comparatively analyze the advantages and disadvantages of banded versus unbanded laparoscopic Roux-en-Y gastric bypass (RYGB). The outcome variables of the general study included morbidity, maximal weight loss, and late weight regain.
Detailed description
Obesity is a public health problem that has grown exponentially worldwide. Bariatric surgery has been recognized as the most effective treatment for morbid obesity. However, the debate about the best surgical procedure is still considerable. Among a wide range of operations that have been used for morbid obesity, Roux-en-Y gastric bypass (RYGB) has shown an appropriate risk/benefit balance and has achieved a high degree of acceptance in America. The weight loss pattern in RYGB is characteristic and includes significant eight loss during the first 2 years after surgery, followed by some weight regain after the second or third postoperative year. To prevent this some authors suggest the placement of a premeasured band or ring around the gastric reservoir, adjacent to the gastroenterostomy. This procedure has been called banded RYGB.
Interventions
PROCEDUREBanded Laparoscopic Roux-en-Y gastric bypass
A 6.5-cm polypropylene Marlex mesh was placed immediately cephalad to the gastrojejunostomy. The gastrojejunostomy was hand-sewn in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer. The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.
PROCEDUREUnbanded Laparoscopic Roux- en-Y gastric bypass
A hand-sewn gastrojejunostomy in 2 layers using 3-0 Polyglactin for the internal and 3-0 silk for the external layer. To ensure a diameter of 1-1.5 cm,a 32F bougie was used to calibrate the gastro jejunum anastomosis. The length of alimentary and biliopancreatic limbs was approximately 150 cm and 50 cm, respectively.
Sponsors
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* body mass index of 40-55 kg/m2 * agreed to participate in this study with informed consent signed
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants with postoperative morbidity | up to 5 years | determine any morbidity related to the surgical procedure through the 5 years follow up |
| Change from Baseline weight assessed at different time points to determine maximal weight loss, | 3,6,9 months and 1,2,5 years | determine changes in weight loss through 5 years follow up, measuring maximal weight loss. |
| Changes in weight assessed at different time points to determine weight regain | 3,6,9 months and 1,2,5 years | identify changes in weight regain during the postoperative 5 years follow up |
Outcome results
None listed