Laparoscopic adjustable banded gastric plication in morbid obesity

ISRCTN ISRCTN17213539
DOI https://doi.org/10.1186/ISRCTN17213539
Secondary identifying numbers EMRP22098N
Submission date
21/09/2010
Registration date
07/10/2010
Last edited
07/10/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Chih-Kun Huang
Scientific

1 Yi-Da Road
Kaohsiung county
824
Taiwan

Phone +886 (0)9 36263146
Email dr.ckhuang@hotmail.com

Study information

Study designProspective cohort trial
Primary study designInterventional
Secondary study designCohort study
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use contact details below to request a patient information sheet
Scientific titleLaparoscopic adjustable banded gastric plication in morbid obesity: a prospective study
Study objectivesTo evaluate the safety and weight loss effect of laparoscopic adjustable banded gastric plication (LABGAP)
Ethics approval(s)The E-Da Institutional Review Board (IRB) approved on the 11th of May 2009 (ref: EMRP22098N)
Health condition(s) or problem(s) studiedMorbid obesity
InterventionGastric banding combined with total greater curvature plication.
This is a single arm trial to evaluate the results and complications associated with the LABGAP. The total duration of follow up is 2 years.
Intervention typeProcedure/Surgery
Primary outcome measure1. Weight loss and BMI reduction, assessed every 3 months from surgery
2. Resolution of co-mobidity after surgery
Secondary outcome measuresComplication and management of surgery
Overall study start date01/04/2009
Completion date30/06/2012

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
Upper age limit65 Years
SexBoth
Target number of participants100
Key inclusion criteria1. Body Mass Index (BMI: kg/m^2) greater than 40
2. BMI between 35 and 40 with associated comorbidities
3. Age 18-65, either sex
Key exclusion criteria1. Substance abuse
2. Psychiatric illnesses that could endanger a close postoperative follow-up
3. History of allergic to silicon materials
Date of first enrolment01/04/2009
Date of final enrolment30/06/2012

Locations

Countries of recruitment

  • China
  • Taiwan

Study participating centre

1 Yi-Da Road
Kaohsiung county
824
Taiwan

Sponsor information

E-DA Hospital (Taiwan)
Hospital/treatment centre

1 Yi-Da Road
Kaohsiung County
824
Taiwan

Email ed105497@edah.org.tw
Website http://www.edah-hospital.com/
ROR logo "ROR" https://ror.org/00eh7f421

Funders

Funder type

Hospital/treatment centre

E-Da hospital (Taiwan)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan