Randomized Trial Comparing Laparoscopic Roux-en-y Gastric Bypass to Micro-laparoscopic Roux-en-y Gastric Bypass

This study compares two groups of patients who have voluntarily chosen to undergo roux-n-y gastric bypass surgery. The groups will be randomized to receive micro-laparoscopic or laparoscopic surgery to be performed by the same surgeon, Dr. Keith Zuccala.

Study Schema

• The patient attends an informational seminar conducted by the Bariatric Surgery Department
• The patient is scheduled for an initial consultation with the bariatric PA/NP where the patient provides: a letter of referral for Bariatric Surgery from primary care doctor or specialty physician; insurance referral; and assurance that health insurance coverage includes Bariatric Surgery.
• Following the initial consultation, the patient is scheduled for the following: comprehensive blood testing; psychological screening/evaluation; dietary evaluation; appointment with the surgeon; pulmonary evaluation (if needed); cardiology evaluation (if needed); gastroenterology evaluation (if needed).
• An appointment for medical clearance with the referring surgeon is scheduled and completed within three weeks of surgery. At this appointment an electrocardiogram (EKG) and repeat blood work will be carried out.
• The patient is deemed to meet all inclusion criteria.
• The patient is advised to follow all pre-operative instructions as advised by the nursing staff and explained in the Danbury Hospital Center for Weight Loss Surgery Guide.
• Surgical procedures performed are standard for those already utilized daily in the surgery department for gastric bypass procedures.
• The patient is closely observed in the hospital and given specific discharge instructions upon leaving the hospital
• The patient is followed for a maximum of 60 days after surgery and asked how many days of work they missed.
• The NSQIP data base and patient medical record are used to assess outcome, postoperative pain, OR time and surgery cost

Inclusion criteria

• A body mass index (BMI) ≥ 40 with or without co-morbid conditions*
• A BMI ≥ 35 with co-morbid conditions*
• Permanent lifestyle changes including exercise
• No significant, untreated psychiatric illnesses
• Age ≥ 18 years
• Sufficient ability and cognition to understand surgery, potential complications and subsequent associated changes
• Willingness to participate in treatment and long-term follow-up
• Proof of failed attempts at non-surgical weight reduction
• Acceptable medical/operative risks * Co-morbid solutions include: hypertension, diabetes mellitus, cardiac disease, hypercholesterolemia/hyperlipidemia, sleep apnea, asthma, hypoventilation syndrome of obesity, degenerative joint disease, gastro-esophageal reflux disease, venous stasis ulcers, depression, menstrual irregularities/infertility, polycystic ovary syndrome, fungal skin infections.

Exclusion criteria

• The need to convert from laparoscopic roux-n-y to an open abdominal procedure.
• Patients with congestive heart failure or other serious illness which would prevent the patient from a successful surgery and recovery
• Women who are nursing or pregnant
• Patients who smoke
• Patient's insurance will not cover the cost of surgery.