Trial Review

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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?
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?
Secondary ID [1] 281178 0
Nil
Universal Trial Number (UTN)
U1111-1134-3424
Trial acronym
The SABROS (Sprayable Adhesion Barriers in Revisional Obesity Surgery) trial
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post-operative, intra-abdominal adhesion formation 287344 0
Condition category
Condition code
Surgery 287682 287682 0 0
Surgical techniques
Diet and Nutrition 287690 287690 0 0
Obesity

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 285627 0
Prevention
Intervention code [2] 285644 0
Treatment: Surgery
Comparator / control treatment
No treatment (patients undergo a standard laparoscopic gastric band removal without use of the intervention)
Control group
Active

Outcomes
Primary outcome [1] 287925 0
Operative time of the laparoscopic sleeve gastrectomy (as calculated by blinded assessor on DVD)
Timepoint [1] 287925 0
Day of surgery
Secondary outcome [1] 299061 0
Time taken to complete dissection during laparoscopic sleeve gastrectomy (as calculated by blinded assessor on DVD)
Timepoint [1] 299061 0
Day of surgery
Secondary outcome [2] 299062 0
Morbidity and mortality as assessed by patient case note review
Timepoint [2] 299062 0
30 days post-laparoscopic sleeve gastrectomy
Secondary outcome [3] 299063 0
Density of adhesions encoutered during laparoscopic sleeve gastrectomy (as calculated by blinded assessor on DVD)
Timepoint [3] 299063 0
Day of surgery

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2012
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
52
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 285949 0
Commercial sector/Industry
Name [1] 285949 0
Covidien PLC
Country [1] 285949 0
Australia
Primary sponsor type
Individual
Name
Dr Michael Talbot
Address
Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
Country
Australia
Secondary sponsor category [1] 284782 0
None
Name [1] 284782 0
Address [1] 284782 0
Country [1] 284782 0
Other collaborator category [1] 277058 0
Individual
Name [1] 277058 0
Dr William Hawkins
Address [1] 277058 0
Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
Country [1] 277058 0
Australia

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 287984 0
Bellberry
Ethics committee address [1] 287984 0
229 Greenhill Road
Dulwich
South Australia 5065
Ethics committee country [1] 287984 0
Australia
Date submitted for ethics approval [1] 287984 0
09/08/2012
Approval date [1] 287984 0
Ethics approval number [1] 287984 0

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34675 0
Address 34675 0
Country 34675 0
Phone 34675 0
Fax 34675 0
Email 34675 0
Contact person for public queries
Name 17922 0
Tania Matisan
Address 17922 0
Upper GI Surgery
Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
Country 17922 0
Australia
Phone 17922 0
+61 2 9553 1120
Fax 17922 0
Email 17922 0
TaniaM@uppergisurgery.com.au
Contact person for scientific queries
Name 8850 0
Dr Michael Talbot
Address 8850 0
Upper GI Surgery
Suite 3, Level 5
St George Private Hospital
1 South Street
Kogarah NSW 2217
Country 8850 0
Australia
Phone 8850 0
+61 2 9553 1120
Fax 8850 0
Email 8850 0
michaelt@uppergisurgery.com.au

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.