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Trial registered on ANZCTR
Registration number
ACTRN12612000965808
Ethics application status
Not yet submitted
Date submitted
5/09/2012
Date registered
7/09/2012
Date last updated
7/09/2012
Type of registration
Prospectively registered
Titles & IDs
Public title
Does reducing intra-abdominal scar tissue formation after removal of a gastric band make subsequent obesity surgery quicker and safer?
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Scientific title
Can the Sprayable Adhesion Barrier SprayShield (Trademark) reduce operating time during laparoscopic sleeve gastrectomy in patients who have previously had laparoscopic removal of a gastric band?
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Secondary ID [1]
281178
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Nil
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Universal Trial Number (UTN)
U1111-1134-3424
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Trial acronym
The SABROS (Sprayable Adhesion Barriers in Revisional Obesity Surgery) trial
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Post-operative, intra-abdominal adhesion formation
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Condition category
Condition code
Surgery
287682
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0
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Surgical techniques
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Diet and Nutrition
287690
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0
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Obesity
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
The intervention is performed at the end of the laparoscopic gastric band removal before removing all the laparoscopic ports. It is a Polymer Kit containing two precursor solutions, a polyethylene glycol (PEG) ester trilysine amine solution and a borate buffer solution. These are mixed together causing the precursors to link forming a synthetic, absorbable, hydrogel adhesion barrier. The reconstituted Polymer Kit syringes are attached to an applicator to allow the polymer to be sprayed onto the operative field. Upon spraying, the polymer liquids mix and rapidly cross-link to form a thin, flexible, tissue adherent, hydrogel adhesion barrier.
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Intervention code [1]
285627
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Prevention
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Intervention code [2]
285644
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Treatment: Surgery
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Comparator / control treatment
No treatment (patients undergo a standard laparoscopic gastric band removal without use of the intervention)
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Control group
Active
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Outcomes
Primary outcome [1]
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Operative time of the laparoscopic sleeve gastrectomy (as calculated by blinded assessor on DVD)
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Assessment method [1]
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Timepoint [1]
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Day of surgery
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Secondary outcome [1]
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Time taken to complete dissection during laparoscopic sleeve gastrectomy (as calculated by blinded assessor on DVD)
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Assessment method [1]
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Timepoint [1]
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Day of surgery
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Secondary outcome [2]
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Morbidity and mortality as assessed by patient case note review
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Assessment method [2]
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Timepoint [2]
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30 days post-laparoscopic sleeve gastrectomy
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Secondary outcome [3]
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Density of adhesions encoutered during laparoscopic sleeve gastrectomy (as calculated by blinded assessor on DVD)
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Assessment method [3]
299063
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Timepoint [3]
299063
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Day of surgery
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Eligibility
Key inclusion criteria
Patients undergoing a staged conversion of a gastric band to a laparoscopic sleeve gastrectomy who meet the following criteria:
1 Any sex
2 Aged over 18
3 Proficient at speaking and understanding written English
4 Ability to understand the consent process
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1 Band erosion as reason for gastric band removal
2 Previous major surgery with suspicion of pre-existing adhesions
3 Pregnant or lactating
4 Renal or hepatic impairment
5 Known allergy to blue food colourings
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Study design
Purpose of the study
Prevention
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 4
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
1/10/2012
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
52
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Funding & Sponsors
Funding source category [1]
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Commercial sector/Industry
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Name [1]
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Covidien PLC
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Address [1]
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166 Epping Road
Lane Cove
NSW 2066
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Country [1]
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Australia
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Primary sponsor type
Individual
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Name
Dr Michael Talbot
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Address
Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
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Country
Australia
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Secondary sponsor category [1]
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None
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Name [1]
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Address [1]
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Country [1]
284782
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Other collaborator category [1]
277058
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Individual
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Name [1]
277058
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Dr William Hawkins
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Address [1]
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Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
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Country [1]
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Australia
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Ethics approval
Ethics application status
Not yet submitted
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Ethics committee name [1]
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Bellberry
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Ethics committee address [1]
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229 Greenhill Road
Dulwich
South Australia 5065
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Ethics committee country [1]
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Australia
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Date submitted for ethics approval [1]
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09/08/2012
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Approval date [1]
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Ethics approval number [1]
287984
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Summary
Brief summary
A randomised trial to determine whether using a sprayable adhesion barrier onto the operative field during removal of a gastric band will make a future laparoscopic sleeve gastrectomy quicker and safer due to reduced scar formation where the gastric band used to be.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Tania Matisan
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Address
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Upper GI Surgery
Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
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Country
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Australia
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Phone
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+61 2 9553 1120
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Name
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Dr Michael Talbot
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Address
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Upper GI Surgery
Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
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Country
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Australia
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Phone
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+61 2 9553 1120
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Fax
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Email
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[email protected]
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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