Resolution of Comorbidities & Safety and Efficacy of Greater Curvature Plication in Obese Patients
NCT ID: NCT02315105
Last Updated: 2014-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
75 participants
INTERVENTIONAL
2011-08-31
2015-08-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
18 Years
65 Years
ALL
No
Sponsors
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Singh, Kuldeep, M.D., P.A.
INDIV
Responsible Party
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Principal Investigators
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Kuldeep Singh, MD
Role: PRINCIPAL_INVESTIGATOR
Saint Agnes Hospital
Locations
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Saint Agnes Hospital
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Kuldeep Singh, MD
Role: primary
Other Identifiers
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NCT0151290
Identifier Type: -
Identifier Source: org_study_id