Trial comparing various methods of liver retraction in Laparoscopic Roux-en-Y Gastric Bypass
| ISRCTN | ISRCTN29657697 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN29657697 |
| Secondary identifying numbers | EMRP30098N |
- Submission date
- 04/11/2011
- Registration date
- 15/11/2011
- Last edited
- 06/11/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Plain English summary of protocol
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
Contact information
Scientific
1 E-Da Road
Jian-Shu Tsuen
Yan-Chau Shiang
Kaohsiung
824
Taiwan
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | A randomised controlled trial comparing various methods of liver retraction in Laparoscopic Roux-en-Y Gastric bypass |
| Study acronym | LRYGB |
| Study objectives | 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(s) | E-Da Hospital Ethics Committee and Institutional Review Board, Taiwan, 15 January 2010 ref: EMRP30098N |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/2010 |
| Completion date | 31/07/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 65 Years |
| Sex | Both |
| Target number of participants | 60, 20 in each group |
| Key inclusion criteria | 1. Age 18-65 years 2. Body mass index (BMI) > 32 kg/m2 3. Written informed consent |
| Key exclusion criteria | 1. Patients younger than 18 or older than 65 years 2. Unresolved psychiatric illness 3. Substance abuse 4. Liver cirrhosis |
| Date of first enrolment | 01/01/2010 |
| Date of final enrolment | 31/07/2010 |
Locations
Countries of recruitment
- Taiwan
Study participating centre
824
Taiwan
Sponsor information
Hospital/treatment centre
No.1, Yida Road
Jiaosu Village
Yanchao District
Kaohsiung
82445
Taiwan
| Website | http://www.edah-hospital.com/en/index.html |
|---|---|
"ROR" |
https://ror.org/00eh7f421 |
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
