Trial Outcomes & Findings for A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients (NCT NCT01409928)

Results Overview

Measure of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

12 months post operation

Results posted on

2020-04-07

Participant Flow

Participant milestones

Participant milestones
Measure	Lap-Band Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure. LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Overall Study STARTED	16
Overall Study COMPLETED	4
Overall Study NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Lap-Band Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure. LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Overall Study Physician Decision	12

Baseline Characteristics

A Study of the Laparoscopically-placed Adjustable Gastric Band for the Management of Obesity in Adolescent Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Lap-Band n=16 Participants Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure. LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Age, Categorical <=18 years	16 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	12 Participants n=93 Participants
Sex: Female, Male Male	4 Participants n=93 Participants

PRIMARY outcome

Timeframe: 12 months post operation

Measure of relative weight adjusted for child age and sex. The Z-score indicates the number of standard deviations away from the mean. A Z-score of 0 is equal to the mean. Negative numbers indicate values lower than the mean and positive numbers indicate values higher than the mean.

Outcome measures

Outcome measures
Measure	Lap-Band n=4 Participants Placement of the LAP-BAND® system will be performed laparoscopically under general anesthesia, using the pars flaccida technique. The device will be placed by surgeons from the University of Texas Southwestern Medical Center Obesity Management Program at Children's Medical Center Dallas. Surgeons will be fully trained in the placement of the LAP-BAND® device, in accordance with FDA approval of the device for the placement in adults. As is current practice in adults undergoing the procedure, incidentally discovered hiatal hernias are repaired at the time of band placement, to reduce the incidence of post-operative reflux. Children receive prophylactic antibiotics, and are observed overnight after surgery. Patients are generally discharged from the hospital the next day. The band will initially be left empty at the end of the placement procedure. LAP-BAND (Allergan, Inc.): Laparoscopic placement of adjustable gastric banding system for the treatment of severe obesity.
Change in Body Mass Index Z-score	-0.26 Z-score Standard Deviation 0.21

Adverse Events

Lap-Band

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Olga T. Gupta

UTSW

Phone: (214) 648-8718

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place