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

ISRCTN ISRCTN32060125
DOI https://doi.org/10.1186/ISRCTN32060125
Protocol serial number EMRP097019
Sponsor E-Da Hospital (Taiwan)
Funder E-Da Hospital (Taiwan)
Submission date
04/10/2010
Registration date
19/10/2010
Last edited
19/10/2010
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
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 Wency Chen
Scientific

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

Study information

Primary study designObservational
Study designRetrospective observational non-randomised study
Secondary study designNon randomised controlled trial
Study type Participant information sheet
Scientific titleCost-effectiveness and surgical outcomes of laparoscopic Roux-en-Y gastric bypass in one Asia center: a retrospective study
Study objectivesTo evaluate the cost-effectiveness and surgical outcome of laparoscopic Roux-en-Y gastric bypass in one Asia Center.
Ethics approval(s)E-Da Institution Review Board approved on the 18th April 2008 (ref: EMRP097019)
Health condition(s) or problem(s) studiedMorbid obesity
InterventionPatients 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 typeOther
Primary outcome measure(s)

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

Key secondary outcome measure(s)

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

Completion date31/12/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration1000
Key inclusion criteria1. Aged 18 - 65 years, either sex
2. Morbid obesity
3. Receving laparoscopic Roux-en-Y gastric bypass
Key exclusion criteria1. Substance abuse
2. Psychiatric illness
Date of first enrolment01/08/2004
Date of final enrolment31/12/2011

Locations

Countries of recruitment

  • Taiwan

Study participating centre

1,Yi-Da Road
Kaohsiung County
824
Taiwan

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes