Condition category
Surgery
Date applied
21/09/2010
Date assigned
07/10/2010
Last edited
07/10/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Chih-Kun Huang

ORCID ID

Contact details

1 Yi-Da Road
Kaohsiung county
824
Taiwan
+886 (0)9 36263146
dr.ckhuang@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMRP22098N

Study information

Scientific title

Laparoscopic adjustable banded gastric plication in morbid obesity: a prospective study

Acronym

Study hypothesis

To evaluate the safety and weight loss effect of laparoscopic adjustable banded gastric plication (LABGAP)

Ethics approval

The E-Da Institutional Review Board (IRB) approved on the 11th of May 2009 (ref: EMRP22098N)

Study design

Prospective cohort trial

Primary study design

Interventional

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use contact details below to request a patient information sheet

Condition

Morbid obesity

Intervention

Gastric 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 type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Weight loss and BMI reduction, assessed every 3 months from surgery
2. Resolution of co-mobidity after surgery

Secondary outcome measures

Complication and management of surgery

Overall trial start date

01/04/2009

Overall trial end date

30/06/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100

Participant exclusion criteria

1. Substance abuse
2. Psychiatric illnesses that could endanger a close postoperative follow-up
3. History of allergic to silicon materials

Recruitment start date

01/04/2009

Recruitment end date

30/06/2012

Locations

Countries of recruitment

China, Taiwan

Trial participating centre

1 Yi-Da Road
Kaohsiung county
824
Taiwan

Sponsor information

Organisation

E-DA Hospital (Taiwan)

Sponsor details

1 Yi-Da Road
Kaohsiung County
824
Taiwan
ed105497@edah.org.tw

Sponsor type

Hospital/treatment centre

Website

http://www.edah-hospital.com/

Funders

Funder type

Hospital/treatment centre

Funder name

E-Da hospital (Taiwan)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes