Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients

Morbid Obesity Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02315105
• Other study ID #: NCT0151290
• Status: Recruiting
• Phase: N/A
• First received: December 9, 2014
• Last updated: December 17, 2014
• Start date: August 2011
• Est. completion date: August 2015

Study information

• Verified date: December 2014
• Source: Singh, Kuldeep, M.D., P.A.
• Contact: Kuldeep Singh, MD
• Phone: 3014902193
• Email: dockds[@]gmail.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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:

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity, Morbid

Intervention

Procedure:
• Laparoscopic Greater Curvature Plication
LGCP is a procedure in which the stomach is folded inwards to that its capacity to hold amount of food is decreased dramatically. This is done under general anesthesia. The operation takes about 1 hour and is done laparoscopically. The attachments of the stomach to the spleen are feed 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 ( Bougie) 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 (EGD- upper endoscopy) to ensure the desired outcome is achieved.

Locations

Country	Name	City	State
United States	Saint Agnes Hospital	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Singh, Kuldeep, M.D., P.A.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent excess weight loss		1 year	No
Secondary	Resolution of Comorbidities	After one year, evaluate each patient to see if the patient has had resolution of any types of comorbidities they manifested pre op; diabetes, hypertension, high cholesterol, mild obstructive sleep apnea, and joint problems	1 year	No