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Trial record 8 of 27 for:    15479938 [PUBMED-IDS]

Multicenter Prospective Randomized Controlled Trial of Plicated Laparoscopic Adjustable Gastric Banding

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01564732
Recruitment Status : Terminated (Sponsor withdrew funding.)
First Posted : March 28, 2012
Results First Posted : June 1, 2016
Last Update Posted : July 1, 2016
Sponsor:
Collaborator:
Allergan
Information provided by (Responsible Party):
Dana Portenier, MD, Duke University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Treatment
Condition Morbid Obesity
Interventions Device: Standard-LAGB
Device: Plicated-LAGB
Enrollment 17
Recruitment Details 17 subjects consented to participate: 1 from Duke University and 16 from the University of Pittsburgh, 6 had not completed surgery before the study termination (2 withdrawn by the PIs and 4 were still in their pre-surgical workup). 11 participants had surgery and were randomized (per the protocol) to plicated band (PLAGB) or standard band (SLAGB).
Pre-assignment Details  
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Period Title: Overall Study
Started 6 5
Completed 0 0
Not Completed 6 5
Reason Not Completed
Early termination by the study sponsor             6             5
Arm/Group Title Standard-LAGB Plicated-LAGB Total
Hide Arm/Group Description

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Total of all reporting groups
Overall Number of Baseline Participants 6 5 11
Hide Baseline Analysis Population Description
[Not Specified]
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
≥18 to ≤60 years Number Analyzed 6 participants 5 participants 11 participants
6 5 11
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 5 participants 11 participants
Female
5
  83.3%
5
 100.0%
10
  90.9%
Male
1
  16.7%
0
   0.0%
1
   9.1%
1.Primary Outcome
Title Weight Loss
Hide Description [Not Specified]
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description:

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Quality of Life
Hide Description [Not Specified]
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
data not collected
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description:

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Quantitative Change in Hypertension
Hide Description Systolic and Diastolic Blood Pressure will be measured over the scheduled visits and the change in preoperative and postoperative blood pressure will be determined. We will also assess the need for medications to treat hypertension before and after surgery.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description:

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
4.Secondary Outcome
Title Quantitative Change in Diabetes
Hide Description Blood Sugar will be measured over the scheduled visits and the change in preoperative and postoperative glucose levels will be determined. We will also assess the need for medications to treat diabetes before and after surgery.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description:

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
5.Secondary Outcome
Title Quantitative Change in Hyperlipidemia
Hide Description Lipid levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hyperlipidemia before and after surgery.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description:

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Quantitative Change in Hypertriglyceridemia
Hide Description Triglyceride levels will be measured annually for 3 years and the change in preoperative and postoperative levels will be determined. We will also assess the need for medications to treat hypertriglyceridemia before and after surgery.
Time Frame 36 months
Hide Outcome Measure Data
Hide Analysis Population Description
Data not collected.
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description:

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Standard-LAGB Plicated-LAGB
Hide Arm/Group Description

Subjects will be blinded and randomly assigned to the Standard Laparoscopic Gastric Banding(SLAGB)arm of the study. These subjects will receive the standard of care or standard laparoscopic gastric banding surgery.Subjects will be followed for a period of approximately 36 months.

Standard-LAGB: The laparoscopic adjustable gastric banding (LAGB) procedure is a safe, effective, and durable treatment option for refractory morbid obesity and its related health consequences.5 This minimally invasive technique is now a popular approach for bariatric surgery, and it offers obvious advantages such as decreased operating time, shorter hospital stay (often same day surgery), and favorable complication rates as compared with other bariatric procedures.

Subjects will be blinded and randomly assigned to the Plicated Laparoscopic Gastric Banding(PLAGB)arm of the study. These subjects will receive the plicated laparoscopic gastric banding surgery with involves the placement of plication sutures to "anchor" the redundant stomach around the newly placed device. Subjects will be followed for a period of approximately 36 months.

Plicated-LAGB: At the time of LAGB placement, plication sutures can be placed along the body & greater curvature of the stomach to "tighten" and "cinch up" the stomach in a sleeve-like orientation. It was recently reported that this modified technique of plicated LAGB could result in lower band slippage complication rates and faster, early weight loss.

All-Cause Mortality
Standard-LAGB Plicated-LAGB
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Standard-LAGB Plicated-LAGB
Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Standard-LAGB Plicated-LAGB
Affected / at Risk (%) Affected / at Risk (%)
Total   1/6 (16.67%)   2/5 (40.00%) 
Cardiac disorders     
Sinus arrhythmia  0/6 (0.00%)  1/5 (20.00%) 
premature atrial contractions  0/6 (0.00%)  1/5 (20.00%) 
Injury, poisoning and procedural complications     
Left hand laceration  0/6 (0.00%)  1/5 (20.00%) 
rotator cuff tear  0/6 (0.00%)  1/5 (20.00%) 
Surgical and medical procedures     
3mm splenic capsular tear  0/6 (0.00%)  1/5 (20.00%) 
2cm abrasion of the left hepatic lobe  1/6 (16.67%)  0/5 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dana Portenier, M.D.
Organization: Duke University Medical Center
Phone: 919-470-7031
EMail: dana.portenier@duke.edu
Publications:
Layout table for additonal information
Responsible Party: Dana Portenier, MD, Duke University
ClinicalTrials.gov Identifier: NCT01564732     History of Changes
Other Study ID Numbers: Pro00033638
First Submitted: March 7, 2012
First Posted: March 28, 2012
Results First Submitted: April 25, 2016
Results First Posted: June 1, 2016
Last Update Posted: July 1, 2016