Use of the INAMED LAPBAND System to Reduce BMI's in Obese Renal Failure Patients
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Issues Related to the Use of the INAMED LAPBAND SYSTEM to Reduce BMI's in Obese Renal Failure Patients Needing Renal Transplantation: A Pilot Study|
- Number of Participants With BMI < 35 kg/m^2 Within 18 Months Following Weight Loss Surgery [ Time Frame: 18 months ] [ Designated as safety issue: No ]See if successful weight loss surgery would allow patients to reduce their preoperative Body Mass Index (BMI in kg/m2) to below 35 kg/m2 within the first 18 months after weight loss surgery in order to see if these patients became eligible for kidney transplantation - most facilities require transplant candidates to have a BMI below 35 kg/m2.
- Document the Occurrence of Any Adverse Events Including Infection and/or Erosion of the LAPBAND and/or Need for Surgical Revision in LAPBAND [ Time Frame: Until recovery from transplant ] [ Designated as safety issue: No ]
|Study Start Date:||October 2005|
|Study Completion Date:||January 2011|
|Primary Completion Date:||November 2010 (Final data collection date for primary outcome measure)|
No Intervention: Group 1 Inamed Lap-Band System
The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years.
Device: Inamed Lap-Band System
Patient's will be seen in the physician's office one week post surgery and once a month thereafter. The device can be gradually adjusted by the insertion of a needle into the port and saline is added or removed to inflate or deflate the LAPBAND. This can be conducted in the physician's office setting to enable the patient to lose 1-2 pounds per week over two.
The concern of transplant surgeons is that obese patients with high BMI's are more likely to experience post-transplantation complications than age-matched recipients . Nevertheless, the Summa transplant list contains numerous patients with renal failure that have BMI's above 35. These patients are not considered to be "active" transplant candidates because of their obesity and are not eligible to receive a kidney transplant. Dr. Lal counsels these patients that they must lose weight in order to be considered active candidates for transplantation.
Weight loss for obese patients in renal failure is difficult. These patients must undergo hemodialysis three times weekly. Most of these patients do not, or physically cannot, engage in exercise activities. Many of these patients are burdened psychologically, and further behavioral responsibilities related to weight loss may overstress them. Repetitive diets or behavioral therapy in morbidly obese patients prior to transplantation have had disappointing results . Likewise, pharmacological management of obesity in these patients is largely unsuccessful. Noradrenergic appetite suppressants must be restricted because of stimulatory side-effects. Serotonergic agents have cardiovascular and pulmonary complications. Thermogenic agents are minimally effective .
The INAMED LAPBAND SYSTEM is an FDA-approved, surgically-placed device marketed to facilitate weight reduction in obese individuals. The LAPBAND is positioned laparoscopically around the stomach and requires an overnight hospitalization and an upper GI swallow the next morning. The device can be gradually adjusted to increase stomach constriction by the physician in an office setting so that the patient loses approximately 1-2 pounds per week over two years. These adjustments are performed on average 4-5 times during the first year and twice during the second year.
The purpose of this pilot study is to assess the utility of the LAPBAND in facilitating weight loss in obese renal failure patients awaiting transplantation and to document issues related to its use in these patients. The hope is that the LAPBAND will facilitate enough weight loss to reduce the patient's BMI to 35 or below after placement of the LAPBAND. If the patient reaches the intended goal of BMI of 35, they will be placed on the active renal transplant list and will be eligible for transplantation.
A secondary goal of this research is to follow those patients who successfully reach BMI's of 35 or less who are subsequently transplanted to determine any untoward effects of the LAPBAND upon transplantation success
Please refer to this study by its ClinicalTrials.gov identifier: NCT00466882
|United States, Ohio|
|Summa Health System|
|Akron, Ohio, United States, 44304|
|Principal Investigator:||John Zografakis, MD||Summa Health System|
|Principal Investigator:||Tanamay Lal, MD||Summa Health System|