Condition category
Nutritional, Metabolic, Endocrine
Date applied
04/10/2010
Date assigned
19/10/2010
Last edited
19/10/2010
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 Wency Chen

ORCID ID

Contact details

1,Yi-Da Road
Yan-Chao Township
Kaohsiung County
824
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMRP097019

Study information

Scientific title

Cost-effectiveness and surgical outcomes of laparoscopic Roux-en-Y gastric bypass in one Asia center: a retrospective study

Acronym

Study hypothesis

To evaluate the cost-effectiveness and surgical outcome of laparoscopic Roux-en-Y gastric bypass in one Asia Center.

Ethics approval

E-Da Institution Review Board approved on the 18th April 2008 (ref: EMRP097019)

Study design

Retrospective observational non-randomised study

Primary study design

Observational

Secondary study design

Non randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

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

Condition

Morbid obesity

Intervention

Patients received laparoscopic Roux-en-Y gastric bypass surgery. Duration of follow up will be at least 3 years for all the patients after surgery.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured immediately during hospitalisation and discharge:
1. Operation time
2. Surgical complication
3. Hospital stay
4. Hospital fee

Secondary outcome measures

1. Excess weight loss at 1st, 3rd ,6th, 9th and 12th month after surgery
2. Long term complication, measured for 3 years follow-up
3. Vitamin and nutrition deficiency, measured for 3 years follow-up

Overall trial start date

01/08/2004

Overall trial end date

31/12/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 years, either sex
2. Morbid obesity
3. Receving laparoscopic Roux-en-Y gastric bypass

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

1000 patients

Participant exclusion criteria

1. Substance abuse
2. Psychiatric illness

Recruitment start date

01/08/2004

Recruitment end date

31/12/2011

Locations

Countries of recruitment

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
Yan-Chao Township
Kaohsiung County
824
Taiwan

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