Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients
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|ClinicalTrials.gov Identifier: NCT02315105|
Recruitment Status : Unknown
Verified December 2014 by Singh, Kuldeep, M.D., P.A..
Recruitment status was: Recruiting
First Posted : December 11, 2014
Last Update Posted : December 18, 2014
|Condition or disease||Intervention/treatment||Phase|
|Morbid Obesity||Procedure: Laparoscopic Greater Curvature Plication||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||August 2011|
|Estimated Primary Completion Date :||August 2015|
|Estimated Study Completion Date :||August 2015|
Experimental: Morbid Obese patients
This purpose of this study is to find out more about the safety and effectiveness of the Laparoscopic Greater Curvature Plication (LGCP) for Morbid Obese Patients with related problems such as diabetes, hypertension, high cholesterol, mild obstructive sleep apnea and joint problems.
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.
- Percent excess weight loss [ Time Frame: 1 year ]
- Resolution of Comorbidities [ Time Frame: 1 year ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02315105
|Contact: Kuldeep Singh, MDfirstname.lastname@example.org|
|Contact: Nicole Sansbury, MPHemail@example.com|
|United States, Maryland|
|Saint Agnes Hospital||Recruiting|
|Baltimore, Maryland, United States, 21229|
|Contact: Kuldeep Singh, MD 301-490-3736 firstname.lastname@example.org|
|Principal Investigator: Kuldeep Singh, MD|
|Principal Investigator:||Kuldeep Singh, MD||Saint Agnes Hospital|