Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients
Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients
The purpose of this study is to find out more about the safety and effectiveness of the
 Laparoscopic Greater Curvature Plication (LGCP) procedure in patients with obesity and
 related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep
 apnea, and joint problems. LGCP is a less invasive weight loss surgery procedure than some of
 the other weight loss surgeries and it is possible that there are fewer risks with this
 procedure than with the other weight loss surgeries. LGCP is considered an experimental
 procedure and this study is being done to look at the long-term outcomes.
LGCP is a procedure in which the stomach is folded inwards to that its capacity to hold
 amounts of food is decreased. This is done under general anesthesia. The operation takes
 about an hour and is done laparoscopically. Laparoscopic approach entails placing 4-5 small
 incisions in the abdomen around the umbilicus and filling the abdomen with CO2 through the
 small tubes called Trocars. this helps life the abdominal wall and create space so that the
 surgeon can carry out his/her work using long instruments with thickness similar to a regular
 lead pencil.

 The attachments of the stomach to the spleen are freed up and the outside is folded inside
 and stitched up to keep it from folding in. To ensure that the surgeon has not obstructed the
 passage in or out of the stomach, a tube is placed in the stomach at the time of the creation
 of the fold and checked again at the end of the procedure with a camera in the stomach which
 is placed through the mouth to ensure the desired outcome is achieved. At the conclusion of
 the procedure, the skin is closed with absorbable sutures and adhesive tapes are applied to
 the skin. The patient recovers in the recovery room for about an hour and a half prior to
 coming to their room in the hospital.

 The post operative visit will be up to 7 days after the procedure. During this visit, medical
 information will be obtained including information about medications.

 There will be follows 3-10 after the surgery. These visits may include:

 -  obtaining medical information about the patient, including the medical conditions and
 medications

 -  Checking the patient's weight

 -  Blood tests

 -  Endoscopic evaluation of the stomach if necessary.

 The timing of the visits is as follows:

 Visit 3: 1 month after surgery Visit 4: 3 months after surgery Visit 5: 6 months after
 surgery Visit 6: 12 months after surgery Visit 7: 18 months after surgery Visit 8: 24 months
 after surgery Visit 9: 30 months after surgery Visit 10: 36 months after surgery

 The study is three (3) years (36 months) including following up visits.
Inclusion Criteria:

 1. Subject is willing to give consent and comply with evaluation and treatment schedule

 2. 18 to 65 years of age

 3. Have a BMI > 30 with one or more significant co-morbid medical conditions which are
 generally expected to be improved, reversed, or resolved by weight loss. these
 conditions include but are not limited to:

 -  Hyperlipidemia

 -  Type 2 diabetes

 -  Mild Obstructive Sleep Apnea

 -  Hypertension

 -  Osteoarthritis of the hip or knee

 4. Agree to refrain from any type of weight-loss drug ( prescription or OTC) or elective
 procedure that would affect body weight for the duration of the trial

 5. HbA1C < 11 %

 6. For subjects who have Type 2 Diabetes, the anti-diabetic medication regimen is no more
 complex than oral metformin plus one oral sulfonylurea plus once daily insulin
 injection.

 7. Ability to self-pay for the procedure and follow up.

 Exclusion Criteria:

 -