Trial Outcomes & Findings for Swedish Adjustable Gastric Banding Observational Cohort Study (NCT NCT01183975)

NCT ID: NCT01183975

Last Updated: 2014-08-08

Results Overview

Mean change in BMI for valid subjects

• Recruitment status: COMPLETED
• Target enrollment: 517 participants
• Primary outcome timeframe: 3 years follow-up
• Results posted on: 2014-08-08

Participant Flow

The cohort consisted of 517 cases of the SAGB implanted by 31 surgeons recruited between 02 SEPT 2007 and 30 April 2008.

Participant milestones

Measure	Patients Treated With SAGB by Solicited Teams Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Overall Study STARTED	517
Overall Study COMPLETED	444
Overall Study NOT COMPLETED	73

Reasons for withdrawal

Measure	Patients Treated With SAGB by Solicited Teams Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Overall Study Lost to Follow-up	73

Baseline Characteristics

Swedish Adjustable Gastric Banding Observational Cohort Study

Baseline characteristics by cohort

Measure	Patients Treated With SAGB by Solicited Teams n=517 Participants Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Age, Continuous	37.5 years STANDARD_DEVIATION 10.92 • n=5 Participants
Gender Female	455 participants n=5 Participants
Gender Male	61 participants n=5 Participants
Region of Enrollment France	517 participants n=5 Participants
Patients treated with SAGB by solicited teams	517 participants n=5 Participants

PRIMARY outcome

Timeframe: 3 years follow-up

Population: 517 valid patients analyzed

Mean change in BMI for valid subjects

Outcome measures

Measure	Patients Treated With SAGB by Solicited Teams n=517 Participants Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Mean BMI Change	-9.03 kg/m^2 Standard Deviation 5.31

PRIMARY outcome

Timeframe: 3 years follow up

Mean excess weight change in valid subjects. Excess weight is calculated as body weight minus ideal body weight, where ideal body weight is determined by the method of Lorentz (Ein neuer Konstitionsinde. Klin Wochenschr 1929; 8:348-51).

Outcome measures

Measure	Patients Treated With SAGB by Solicited Teams n=517 Participants Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Mean Excess Weight Change	-45.76 percent change in excess weight Standard Deviation 29.97

Adverse Events

Patients Treated With SAGB by Solicited Teams

Serious events: 123 serious events

Other events: 26 other events

Deaths: 0 deaths

Serious adverse events

Measure	Patients Treated With SAGB by Solicited Teams n=517 participants at risk Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Gastrointestinal disorders Band Removal	13.0% 67/517 • Number of events 67 • 3 years
Skin and subcutaneous tissue disorders abdominoplasty	4.4% 23/517 • Number of events 23 • 3 years
Gastrointestinal disorders port re-interventions without port removal	4.3% 22/517 • Number of events 22 • 3 years
Gastrointestinal disorders port removal	1.5% 8/517 • Number of events 8 • 3 years
Gastrointestinal disorders band re-interventions without removal	0.58% 3/517 • Number of events 3 • 3 years

Other adverse events

Measure	Patients Treated With SAGB by Solicited Teams n=517 participants at risk Patients treated with SAGB by solicited teams. No selection criteria at cohort inclusion applied to the 500 (+50) first patients treated in order to ensure consecutive and exhaustive recruitment in the concerned centers over the inclusion period.
Gastrointestinal disorders band-related: Slippage	5.0% 26/517 • Number of events 26 • 3 years

Additional Information

Birgit Temiz

Ethicon, Inc.

Phone: +49 (0) 40 5297 3144

Email: btemiz@its.jnj.com

Results disclosure agreements

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

Restriction type: LTE60