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Topic by: Jayann Brown
Affiliation: Clinical Research Program
Humber College Institute of Technology and
Advanced Learning...
 Title: Laparoscopic Gastric Bypass vs. LAP
BAND for treatment of morbid obesity
 Clinical Trials.gov identifier: NCT002...
 LAP-BAND can be performed safely and is
associated with reduced postoperative pain,
decrease in morbidity, decreased ICU...
 Severe obesity or morbid obesity (being 100lbs
above ideal body weight) is a growing problem
in the U.S.
 Individuals e...
 Roux-en-Y gastric Bypass (GBP) is the golden
standard bariatric surgical operation
 Mean weight loss following GBP = Ap...
 In 2001 FDA approved the Laparoscopic
Adjustable banding system (LAP-BAND) for
weight reduction in morbid obese individu...
 The LAP-BAND®
consists of a silicone
gastric band which
encircles the stoma.
 The inner surface of the
silicone band is...
 5 holes drilled in stomach , camera guides the
placement of the band around the upper part
of the stomach.
 The band cr...
ROUX- EN- Y LAP-BAND
 To determine the short-term outcome, quality-of-
life, costs, and long-term weight loss after
laparoscopic GBP compared ...
 There will be two arms each projected to have
100 subjects for clinical significance of 0.05%.
 Arm1. Active comparator...
 Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
 Body mass index (BMI) 40 kg/m2 or BMI 35
kg/m2 with significant obesity-related co-
morbidities ( Normal BMI = 20-25kg/m...
 Male or female patients with a BMI of 40-60
kg/m2 or 35kg/m2 with co-morbidities
 Good health status with acceptable op...
 Prior upper abdominal surgery except
cholecystectomy
 Large abdominal ventral hernia
 Hiatal hernia
 Inadequate prior...
 The pre-operative screening will consist of:
 Physical exam
 Psychological exam,
 Complete blood tests,
 Imaging stu...
 PRIMARY OUTCOME MEASURE
 Excess Weight Loss From Pre-operation to 5 Years Post-
operation (weight loss as measured by c...
 Changes in Quality of Life: Physical Role- Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation. (
0 corr...
 Changes in Quality of Life: General Health. Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation (0
corre...
 Changes in Quality of Life : Emotional Role. Using SF-36
Questionnaire Pre-operation to 12 Months Post-operation ( 0
cor...
 Common side effects include nausea and
vomiting, heartburn, abdominal pain, and
slippage of the band
 Serious Adverse E...
 Check-ups with the doctor is very important
part of Lap Band follow-up.
 If necessary adjustments are done.
 Depending...
 Will be determined by the severity and will be determined
as :
 Mild - symptom barely noticeable to the patient; does n...
 Determined to be clinically effective if:
 40% of the patients achieve weight loss of 30% of
excess weight after 1yr
 ...
 P000008/S017: FDA Summary of Safety and Effectiveness .Retrieved 3/26/2014
from website http://www.accessdata.fda.gov/cd...
Clinical Investigation of  the LAP-BAND medical device
Clinical Investigation of  the LAP-BAND medical device
Clinical Investigation of  the LAP-BAND medical device
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Clinical Investigation of the LAP-BAND medical device

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Clinical Investigation of the LAP-BAND medical device

  1. 1. Topic by: Jayann Brown Affiliation: Clinical Research Program Humber College Institute of Technology and Advanced Learning March 2014
  2. 2.  Title: Laparoscopic Gastric Bypass vs. LAP BAND for treatment of morbid obesity  Clinical Trials.gov identifier: NCT00247377  Trial was completed (App. 6 yrs)  Principal Investigator: Ninh T Nguyen MD  Sponsor Organization: University of California  Clinical trial was conducted at University of California Irvine Medical Center
  3. 3.  LAP-BAND can be performed safely and is associated with reduced postoperative pain, decrease in morbidity, decreased ICU and hospital stay, reduced costs, comparable improvement in quality-of-life, and acceptable long-term weight loss compared with laparoscopic GBP  LAP-BAND is associated with a decrease in fluid requirement in the peri-operative period, improved postoperative pulmonary function, and lower intra- abdominal pressure compared to laparoscopic GBP  LAP-BAND does not alter esophageal motility and is effective in improvement of gastro-esophageal reflux disease (GERD) symptoms.
  4. 4.  Severe obesity or morbid obesity (being 100lbs above ideal body weight) is a growing problem in the U.S.  Individuals engaged in exercise ,dietary restriction, behaviour modification, pharmacological intervention regained weight in 2-4 yrs  Surgery is the only effective sustained weight loss treatment ( NIH conference 1991)
  5. 5.  Roux-en-Y gastric Bypass (GBP) is the golden standard bariatric surgical operation  Mean weight loss following GBP = App. 65% of the excess body weight during the first 12 - 18 mths  Long-term weight loss= App. 55-70% of excess body weight  Open & Laparoscopic GBP is associated with significant mortality and morbidity, anastomotic leak, pulmonary embolism, bowel obstruction, and postoperative stricture.
  6. 6.  In 2001 FDA approved the Laparoscopic Adjustable banding system (LAP-BAND) for weight reduction in morbid obese individuals  No cutting or opening of the stomach wall  Purpose of the study: to evaluate if the LAP- BAND procedure is as effective as the laparoscopic GBP procedure for treatment of morbid obesity.
  7. 7.  The LAP-BAND® consists of a silicone gastric band which encircles the stoma.  The inner surface of the silicone band is inflatable and is connected by the tubing to the access port.  Class III medical device  Premarket approval #: P000008/S017
  8. 8.  5 holes drilled in stomach , camera guides the placement of the band around the upper part of the stomach.  The band creates a small stomach pouch that can hold only a small amount of food.  The surgeon adjusts the band by (adding or removing fluid, usually saline) by using a needle to pierce the access port, which is placed just beneath the skin.
  9. 9. ROUX- EN- Y LAP-BAND
  10. 10.  To determine the short-term outcome, quality-of- life, costs, and long-term weight loss after laparoscopic GBP compared with LAP-BAND.  To compare physiologic changes such as peri- operative fluid requirement, postoperative pulmonary function, and intra-abdominal pressure after laparoscopic GBP and LAP-BAND.  To evaluate the effect of LAP-BAND on esophageal motility and its effectiveness in controlling gastro-esophageal reflux symptoms (GERD) for morbidly obese patients.
  11. 11.  There will be two arms each projected to have 100 subjects for clinical significance of 0.05%.  Arm1. Active comparator- LAP BAND  Arm2. Active comparator –Laparoscopic GBP  Dropout rate is expected to be app. 20% (N= n/1-d) The total number of subjects estimated to be enrolled in the program is 250.
  12. 12.  Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
  13. 13.  Body mass index (BMI) 40 kg/m2 or BMI 35 kg/m2 with significant obesity-related co- morbidities ( Normal BMI = 20-25kg/m2)  Acceptable operative risk  Documented failure of nonsurgical weight-loss programs  Psychologically stable with realistic expectations  Well-informed and motivated patient  Supportive family/social environment  Absence of uncontrolled psychotic or depressive disorder  No active alcohol or substance abuse
  14. 14.  Male or female patients with a BMI of 40-60 kg/m2 or 35kg/m2 with co-morbidities  Good health status with acceptable operative risk ( good cardiopulmonary function)  A willingness to follow protocol requirements: i.e. signing informed consent forms, follow –up and completing protocol diagnostic tests.
  15. 15.  Prior upper abdominal surgery except cholecystectomy  Large abdominal ventral hernia  Hiatal hernia  Inadequate prior medical management  Lack of patient motivation and contribution to long term success (Patient must be willing to make major changes in their eating habits and lifestyle)  Unacceptable operative risk  Minors are not psychologically fit to undergo such surgery and pregnant women are excluded because of safety for the fetus
  16. 16.  The pre-operative screening will consist of:  Physical exam  Psychological exam,  Complete blood tests,  Imaging studies,  Gastroscopy,  Consultations with various specialists : surgeon, endocrinologist, clinical nutritionist.  See Study Table
  17. 17.  PRIMARY OUTCOME MEASURE  Excess Weight Loss From Pre-operation to 5 Years Post- operation (weight loss as measured by change in percent of excess body weight)  [Time Frame: Baseline to 5 years [ Designated as safety issue: No ]  SECONDARY OUTCOME MEASURES  Changes in Quality of Life: Physical Functioning. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation (Response where 0 is non-functioning and 100 is fully functioning)  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]  Cost of Procedure to the Medical Facility on Date of Procedure (operative and post-operative direct costs including hospital service costs per patient. costs reflect the average cost per patient in each of the two groups (band vs. bypass) at a single time point)  [ Time Frame: date of surgery ] [ Designated as safety issue: No ]
  18. 18.  Changes in Quality of Life: Physical Role- Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation. ( 0 corresponds to no Physical Role and 100 corresponds to full Physical Role )  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]  Changes in Quality of Life: Bodily Pain Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation. (0 corresponds to no bodily pain and 100 corresponds to complete bodily pain )  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
  19. 19.  Changes in Quality of Life: General Health. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation (0 corresponds to no general health satisfaction and 100 corresponds to complete health satisfaction )  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]  Changes in Quality of Life: Vitality. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation ( worst score being 0 and best score being 100 on a 1-100 point scale.)  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]  Changes in Quality of Life: Social Functioning. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation (Response where 0 corresponds to no social functioning and 100 corresponds to full social functioning )  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
  20. 20.  Changes in Quality of Life : Emotional Role. Using SF-36 Questionnaire Pre-operation to 12 Months Post-operation ( 0 corresponds to no emotional role and 100 corresponds to full emotional role)  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]  Changes in Quality of Life: Mental Health. Using SF-36 Questionnaire From Pre-operation to 12 Months Post-operation (0 corresponds to no mental health well-being and 100 corresponds to complete mental health well-being)  [ Time Frame: Baseline to 12 months ] [ Designated as safety issue: No ]
  21. 21.  Common side effects include nausea and vomiting, heartburn, abdominal pain, and slippage of the band  Serious Adverse Events include: erosion of the stomach, mortality (1/2000)  The most serious side effects require either another operation or hospitalization.  Surgery is reversible and LAP BAND can be removed
  22. 22.  Check-ups with the doctor is very important part of Lap Band follow-up.  If necessary adjustments are done.  Depending on individual case checks will be  First month- Weekly or biweekly  First year: 4-12 weeks  Second and third year:3-6 mths  Up to 5 yrs: annually
  23. 23.  Will be determined by the severity and will be determined as :  Mild - symptom barely noticeable to the patient; does not affect performance or functioning. Prescription drugs not ordinarily needed for relief of symptom.  Moderate - symptom of sufficient severity to make patient uncomfortable; performance of daily activities affected; patient is unable to continue in study. Treatment of symptoms is needed.  Severe - symptom causes severe discomfort and may be such that patient cannot perform daily activities. Severity may result in cessation of treatment or require removal of the device, or treatment of symptom may be given and/or patient hospitalized.
  24. 24.  Determined to be clinically effective if:  40% of the patients achieve weight loss of 30% of excess weight after 1yr  Co-morbid conditions e.g.. type II diabetes, hypertension measures are reduced  Quality of life by the impact of weight loss is improved based on SF-36
  25. 25.  P000008/S017: FDA Summary of Safety and Effectiveness .Retrieved 3/26/2014 from website http://www.accessdata.fda.gov/cdrh_docs/pdf/P000008S017b.pdf  Schematic of study Design . Retrieved3/22/ 2014 from website www.nidcr.nih.gov/NR/.../0/Schematic_of_Study_Design_Form.doc  Laparoscopic gastric banding Retrieved 3/22/2014 from website http://www.nlm.nih.gov/medlineplus/ency/article/007388.htm  LAP-BAND® Adjustable Gastric Banding System - P000008/S017. Retrieved 3/22/2014 http://www.fda.gov/medicaldevices/productsandmedicalprocedures/deviceapp rovalsandclearances/recently-approveddevices/ucm248133.htm  Laparoscopic gastric bypass vs. LAP-BAND for Treatment of Morbid Obesity. Retrieved from 3/7/2014 from http://clinicaltrials.gov/ct2/show/NCT00247377?term=laparoscopic+lapband&ra nk=1

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