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

Primary Purpose

Obesity

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Laparoscopic Greater Curvature Plication
Sponsored by
Singh, Kuldeep, M.D., P.A.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obesity focused on measuring obesity, Laparoscopic Greater Curvature Plication, Percent Excess weight Loss, comorbidities, BMI, Bariatric Surgery

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Saint Agnes HospitalRecruiting

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
January 15, 2012
Last Updated
March 11, 2012
Sponsor
Singh, Kuldeep, M.D., P.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01512940
Brief Title
Resolution of Comorbidities, Safety and Efficacy of Greater Curvature Plication in Obese Patients.
Acronym
LGCP
Official Title
Laparoscopic Greater Curvature Plication for Weight Loss and Resolution of Diabetes and Other Comorbidities.
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
October 2012 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Singh, Kuldeep, M.D., P.A.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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 .
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
obesity, Laparoscopic Greater Curvature Plication, Percent Excess weight Loss, comorbidities, BMI, Bariatric Surgery

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Procedure
Intervention Name(s)
Laparoscopic Greater Curvature Plication
Other Intervention Name(s)
Bariatric Surgery
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent excess weight loss
Description
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.
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Resolution of comorbidities
Description
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.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject is willing to give consent and comply with evaluation and treatment schedule; 18 to 65 years of age (inclusive); 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 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; HbA1C < 11% 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. Ability to self pay for the procedure and follow up. Exclusion Criteria: Previous malabsorptive or restrictive procedures performed for the treatment of obesity; Scheduled concurrent surgical procedure, with the exception of SOC liver biopsy; Women of childbearing potential who are pregnant or lactating at the time of screening or at the time of surgery; Any condition which precludes compliance with the study; History or presence of pre-existing autoimmune connective tissue disease 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. 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kuldeep Singh, MD
Organizational Affiliation
Kuldeep Singh, MDPA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Agnes Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kuldeep Singh, MD
Phone
301-490-3736
Email
lapman21229@yahoo.com
First Name & Middle Initial & Last Name & Degree
Isam Hamdallah, MD
Phone
301-490-2193
Email
galag50@hotmail.com
First Name & Middle Initial & Last Name & Degree
Kuldeep Singh, MD
First Name & Middle Initial & Last Name & Degree
Isam Hamdallah, MD

12. IPD Sharing Statement

Learn more about this trial

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

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