Condition category
Nutritional, Metabolic, Endocrine
Date applied
27/09/2010
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

Yi-Da Road
Kaohsiung County
824
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMRP17098N

Study information

Scientific title

Single-incision transumbilical laparoscopic Roux-en-Y gastric bypass: a prospective non-randomised controlled study

Acronym

Study hypothesis

1. To evaluate the feasibility and safety of single-incision transumbilical laparoscopic Roux-en-Y gastric bypass
2.To compare the surgical outcome of the single incision transumbilical and 5-ports laparoscopic Roux-en-Y gastric bypass

Ethics approval

E-Da Institutional Review Board (IRB) approved on the 13th August 2009 (ref: EMRP17098N)

Study design

Prospective non-randomised controlled study

Primary study design

Interventional

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/type II diabetes meliitus

Intervention

The study prospectively compares single incision transumbilical laparoscopic Roux en Y gastric bypass (intervention arm) and conventional 5-port laparoscopic Roux en Y gastric bypass (control arm). Patients can choose which surgery they prefer for themselves. The total duration for treatment is 2 years and all patients are followed 2 years.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measured peri-operatively and 3 months post-operatively:
1. Operation time
2. Intra-operative complication
3. Post-operative complication
4. Analgesic use
5. Hospitalisation

Secondary outcome measures

1. Excess weight loss in first year, measured at 1, 3, 6, 9 and 12 months
2. Wound satisfaction, measured at 3 months

Overall trial start date

01/11/2008

Overall trial end date

31/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

All patients (aged 18 - 65 years, either sex) considered for laparoscopic Roux-en-Y gastric bypass as the treatment method for morbid obesity or Type II Diabetes mellitus

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

100 patients

Participant exclusion criteria

1. Body mass index (BMI) greater than 50
2. Body height greater than 180 cm

Recruitment start date

01/11/2008

Recruitment end date

31/12/2010

Locations

Countries of recruitment

Taiwan

Trial participating centre

Yi-Da Road
Kaohsiung County
824
Taiwan

Sponsor information

Organisation

E-Da Hospital (Taiwan)

Sponsor details

1 Yi-Da Road
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