Skip to content

Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy

Prospective Randomized Study of Effects of Laparoscopic Roux-en-Y Gastric Bypass Versus Laparoscopic Sleeve Gastrectomy

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00667706
Enrollment
200
Registered
2008-04-28
Start date
2008-04-30
Completion date
Unknown
Last updated
2008-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Morbid Obesity

Brief summary

The sleeve gastrectomy that has been utilized as a first-stage bariatric procedure to reduce surgical risk in high-risk patients by induction of weight loss is now gaining popularity as a standalone procedure for the treatment of morbid obesity. It appears to be a technically easier and/or faster laparoscopic procedure than Roux-en-Y gastric bypass. It brings good weight loss results, in some studies even comparable to the RYGB and Biliopancreatic Diversion with Duodenal Switch. The mechanism of action is assumed to be purely restrictive, but some neurohumoral interaction may exist. Almost no data exist on the influence of the sleeve gastrectomy on the medical and general quality of life or resolution of comorbidities. The rates of the comorbidities resolution 12 to 24 months after sleeve gastrectomy has been reported in the range that seems to be higher than for the purely restrictive procedures. Our goal is to to compare the surgical and weight loss outcomes between the two procedures, their influence on resolution of common comorbidities and on quality of life change. 150 eligible candidates will be randomized into two groups, one will undergo Laparoscopic Sleeve Gastrectomy, the other will have Laparoscopic Roux-en-Y Gastric Bypass done. Detailed evaluation and preoperative questionnaires will be used to obtain demographic and medical data, and quality of life will be assessed. General metabolic and nutritional work up will be done, and will be reassessed at different intervals up to 5 years, in order to compare the short and long term results of the two procedures.

Interventions

PROCEDURElaparoscopic operation Sleeve Gastrectomy

Laparoscopic Sleeve Gastrectomy will be performed employing a 5-6 trocar technique, and includes gastric resection starting 4-5 cm proximal to the pylorus, using a 38 fr. Bougie and endoscopic stapler with blue and green load.

PROCEDURElaparoscopic operation Roux-en-Y Gastric bypass

Divided LRYGB will employ 5-7 trocars technique, and includes stapled jejunojejunostomy 30-50 cm distal to the Treitz ligament, gastric pouch of 20 cc., and antecolic, antegastric gastrojejunal anastomosis, either two layered hand-sawn, GIA, or EEA-25 -stapled, at surgeons preference. The length of the Roux limb will be 100 centimeters or 150 centimeters in patients with BMI of \<50, and \>50, respectively.

Sponsors

Carmel Medical Center
CollaboratorOTHER
Hadassah Medical Organization
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

Inclusion criteria

* Adult patients with morbid obesity

Exclusion criteria

* Pregnancy, * Previous bariatric operation, * IBD, * Previous bowel or stomach surgery

Design outcomes

Primary

MeasureTime frame
weight loss5 years

Secondary

MeasureTime frame
short and long term complication rates, length of stay, need for re-operations efficiency of the procedure in inducing weigh loss and resolution of common co-morbidities5 years

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026