Trial Outcomes & Findings for Laparoscopic Adjustable Gastric Banding in Adolescents (NCT NCT01619488)

NCT ID: NCT01619488

Last Updated: 2023-08-01

Results Overview

Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 57 participants
• Primary outcome timeframe: Up to five years post surgery.
• Results posted on: 2023-08-01

Participant Flow

Eligible patients were recruited from the pediatric weight management clinic.

Of 136 eligible patients, 57 completed the pre-intervention program and underwent placement of the gastric band. The remainder opted out of the intervention.

Participant milestones

Measure	Gastric Banding Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction. Adjustable Gastric Band: Surgical placement of an adjustable gastric band around the upper portion of the stomach. Adjustments are made to the band through a subcutaneous port as needed to maintain appropriate restriction.
Overall Study STARTED	57
Overall Study COMPLETED	57
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Laparoscopic Adjustable Gastric Banding in Adolescents

Baseline characteristics by cohort

Measure	Gastric Band n=57 Participants Lap Band Surgery was ultimately performed on 57 patients, the remainder chose alternative management.
Age, Categorical <=18 years	56 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	1 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	16.05 years STANDARD_DEVIATION 1.22 • n=5 Participants
Sex: Female, Male Female	48 Participants n=5 Participants
Sex: Female, Male Male	9 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	16 Participants n=5 Participants
Race (NIH/OMB) White	37 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	3 Participants n=5 Participants
Region of Enrollment United States	57 participants n=5 Participants
Weight	139.36 Kilogram STANDARD_DEVIATION 19.7 • n=5 Participants

PRIMARY outcome

Timeframe: Up to five years post surgery.

Weight loss in kilograms Weight on day of surgery minus last weight recorded before end of trial

Outcome measures

Measure	Weight Loss n=57 Participants 57 Patients who underwent Adjustable gastric band surgery
Total Weight Loss	11.35 kilograms Standard Deviation 19.08

SECONDARY outcome

Timeframe: Baseline

Fasting insulin level

Outcome measures

Measure	Weight Loss n=57 Participants 57 Patients who underwent Adjustable gastric band surgery
Insulin Resistance	12.5 uIU/ml Standard Deviation 14.0

Adverse Events

Adverse Events

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Adverse Events n=57 participants at risk 2 Adverse events requiring successful removal of band for slipped bands.
Gastrointestinal disorders Band slippage, leading to removal	3.5% 2/57 • Number of events 2 • 5 years

Other adverse events

Adverse event data not reported

Additional Information

Kirk W Reichard, MD, MBA, Surgical Director

Nemours Childrens Health Delaware

Phone: 302-651-5999

Email: kreichar@nemours.org

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place