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

Obesity Clinical Trial

— LGCP  

Official title:

Laparoscopic Greater Curvature Plication for Weight Loss and Resolution of Diabetes and Other Comorbidities.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01512940
• Other study ID #: RPN 2011-024
• Status: Recruiting
• Phase: N/A
• First received: January 15, 2012
• Last updated: March 11, 2012
• Start date: October 2011
• Est. completion date: October 2014

Study information

• Verified date: March 2012
• Source: Singh, Kuldeep, M.D., P.A.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Laparoscopic gastric plication or laparoscopic greater curvature placation ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.

The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss .

Description:

Since the acceptance of surgical procedures to achieve a sustainable weight loss, many different procedures has been tried with variable success. Among them , various gastric restrictive procedures have evolved over the years but abandoned due to poor long term weight loss, food intolerance or severe gastroesophageal reflux. Currently, laparoscopic adjustable gastric band ( LAGB) and sleeve gastrectomy are being used with variable acceptance and success. Laparoscopic gastric plication or laparoscopic greater curvature plication ( LGCP) has recently been done as an alternative to the other restrictive procedures. But the short and long term safety and efficacy outcomes of LGCP is not well documented in current literature. American society of metabolic and bariatric surgery ( ASMBS) guidelines state that LGCP procedures should be considered investigational at this time and should be performed under a study protocol with third party oversight (e.g. IRB) to ensure continuous evaluation of patient safety and to review adverse events and outcomes.

A prospective nonrandomized study at Cleveland clinic suggested that a reduction in gastric capacity can be achieved by way of plication of stomach and thereby achieving encouraging weight loss. We intend to study this procedure as an alternative to LAGB or sleeve gastrectomy for carefully selected patients. The objective of this study will be to demonstrate feasibility , short term and long term safety and efficacy of LGCP . This will be done by achieving gastric restriction by infolding of stomach and thereby achieving good weight loss . The subjects will be followed up post operatively to observe the effect on the comorbidities along with sustained weight loss. The inclusion and exclusion criteria , target population, duration of subject participation and primary endpoints will be defined and all the data will be recorded per protocol.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: October 2014
• Est. primary completion date: October 2012
• 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 (inclusive);

3. Have a BMI > 27 with one or more significant co-morbid medical conditions which are generally expected to be improved, reversed, or resolved by weight loss. These conditions may include but are not be 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:

1. Previous malabsorptive or restrictive procedures performed for the treatment of obesity;

2. Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy;

3. Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery;

4. Any condition which precludes compliance with the study;

5. History or presence of pre-existing autoimmune connective tissue disease

6. Use of prescription or over the counter weight reduction medications or supplements within thirty days of the Screening Visit or the duration of study participation.

7. Psychiatric disorders that may affect compliance with the clinical trial, including dementia, active psychosis, severe depression requiring > 2 medications, or history of suicide attempts. Any condition which places the subject at undue risk for the procedure (surgeon's discretion).

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Procedure:
• Laparoscopic Greater Curvature Plication
The greater curvature of the stomach is separated from the greater omentum. At least two rows of at least five continuous stitches will be placed about the greater curvature of the stomach starting at or near the angle of His and ending in the antrum. An endoscope will be used to maintain a lumen during the procedure. The two tissue bites of an individual stitch will be centered about the intended fold line. Subsequent stitches will be uniformly spaced distally along the length of the fold. The second row of sutures will be placed across the fold line created by the previous row of sutures in the same fashion as the first row. Up to 2 additional rows may be added as required to achieve this result (for a total of up to 4 rows). Upon completion of the procedure, the section of the stomach infolded by the sutures will be inspected using the endoscope.

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	The percent excess weight loss at 3-years from the time of surgery. The primary analysis will include all available data at the 3-year follow-up.	3 years	No
Secondary	Resolution of comorbidities	The following comorbidities will be assessed at regular intervals: diabetes, dyslipidemia, liver dysfunction, and hypertension. Measures will include glycosylated hemoglobin, triglycerides, low-density lipoprotein, high-density lipoprotein, serum albumin, liver transaminases, systolic and diastolic blood pressures.	3 years	No