Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients
| Status: | Completed |
|---|---|
| Conditions: | Obesity Weight Loss |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 4/2/2016 |
| Start Date: | August 2011 |
| End Date: | August 2015 |
| Contact: | Kuldeep Singh, MD |
| Email: | dockds@gmail.com |
| Phone: | 3014902193 |
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.
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.
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:
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