Condition category
Surgery
Date applied
04/11/2011
Date assigned
15/11/2011
Last edited
06/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Liver retraction is necessary during Laparoscopic Roux-en-Y gastric Bypass (LRYGB) surgery to make sure that the surgeon has enough space and can see what they are doing. Hypertrophic fatty left lobe of the liver in morbidly obese patients makes liver retraction more challenging for surgeons dealing with weight loss surgery (called bariatric surgeons). Traditional liver retractors require another wound for insertion, are bulky and may cause liver injury. This additional wound may also lead to local wound infection, port site hernia and may add to post-operative pain and discomfort. The response of the liver to the retraction also needs to be addressed. This is the aim of this study which compared three methods: the traditional Nathanson liver retractor (Group I), liver suspension tape (Group II), V shaped liver suspension technique called V-LIST (Group III).

Who can participate?
Patients aged 18-65 years, with a BMI > 32 kg/m2 and who have given written informed consent.

What does the study involve?
Participants are randomly allocated to three groups: Nathanson liver retractor (Group I), Liver suspension tape (Group II) and (Group III) on the basis of method of liver retraction used and taken for surgery Laparoscopic Roux-en-Y gastric Bypass (LRYGB).

What are the possible benefits and risks of participating?
The patients in Group II and III may benefit from less liver trauma, fewer trocar wound related complications (a trocar is the device that will be used to provide better access to the abdomen).
The patients may need more operative time in Group II and III.

Where is the study run from?
The study will take place at EDa Hospital, Kaohsiung City (Taiwan)

When is the study starting and how long is it expected to run for?
January 2010 to July 2010.

Who is funding the study?
EDa Hospital, Kaohsiung City (Taiwan)

Who is the main contact?
Professor Chih-Kun Huang
dr.ckhuang@hotmail.com

Trial website

Contact information

Type

Scientific

Primary contact

Prof Chih-Kun Huang

ORCID ID

Contact details

1 E-Da Road
Jian-Shu Tsuen
Yan-Chau Shiang
Kaohsiung
824
Taiwan

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EMRP30098N

Study information

Scientific title

A randomised controlled trial comparing various methods of liver retraction in Laparoscopic Roux-en-Y Gastric bypass

Acronym

LRYGB

Study hypothesis

The patients may benefit from novel retraction techniques like Liver suspension tape, V-shaped liver suspension technique with less trauma to liver and less scarring.

Ethics approval

E-Da Hospital Ethics Committee and Institutional Review Board, Taiwan, 15 January 2010 ref: EMRP30098N

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

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

Laparoscopic roux-en-y gastric bypass for obese patients

Intervention

Eligible consenting participants (N=60) will be randomised into 3 groups:
Group I: Nathanson Liver Retractor (n=20)
Group II: Liver Suspension Tape (n=20)
Group III: V-LIST (n=20)

Preoperative liver function test (LFT) (SGOT, SGPT, Total Bilirubin)
Preoperative Liver dimensions measurement

Surgery: We recorded gastric pouch time, operative time, time for liver suspension, Operative view score, Difficulty score, Visual analogue scale (VAS) for pain

LFT (SGOT, SGPT, Total Bilirubin):
Immediate Postop, 18 hours, 1 week and 1 month.

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

1. Liver Function Test (LFT) just before surgery immediately post operation and at 18 hours, 1 week and at 1 month after surgery
2. Intra-operative time for gastric pouch, time taken for liver suspension and total operative time

Secondary outcome measures

1. Liver dimensions
2. Difficulty and operative view scores
3. Visual analogue scale) VAS
Measured at post operation after day 1 and day 2

Overall trial start date

01/01/2010

Overall trial end date

31/07/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Age 18-65 years
2. Body mass index (BMI) > 32 kg/m2
3. Written informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

60, 20 in each group

Participant exclusion criteria

1. Patients younger than 18 or older than 65 years
2. Unresolved psychiatric illness
3. Substance abuse
4. Liver cirrhosis

Recruitment start date

01/01/2010

Recruitment end date

31/07/2010

Locations

Countries of recruitment

Taiwan

Trial participating centre

1 E-Da Road
Kaohsiung
824
Taiwan

Sponsor information

Organisation

E-Da Hospital (Taiwan)

Sponsor details

No.1
Yida Road
Jiaosu Village
Yanchao District
Kaohsiung
82445
Taiwan

Sponsor type

Hospital/treatment centre

Website

http://www.edah-hospital.com/en/index.html

Funders

Funder type

Hospital/treatment centre

Funder name

E-Da Hospital Kaohsiung (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