Trial Review

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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626000953336
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
14/07/2026
Date registered
Help: Date registered
3/08/2026
Date last updated
Help: Date last updated
3/08/2026
Date data sharing statement initially provided
Help: Data sharing statement date
3/08/2026
Date results provided
Help: Date results provided
3/08/2026
Type of registration
Help: Type of registration
Retrospectively registered

Titles & IDs
Public title
Randomised Controlled Trial Comparing Laparoscopic Instrument Exchange Time Using the Surgirack™ vs Standard Instrument Holder in Laparoscopic Roux-en-Y Gastric Bypass
Scientific title
Randomised Controlled Trial Comparing Laparoscopic Instrument Exchange Time Using the Surgirack™ vs Standard Instrument Holder in Laparoscopic Roux-en-Y Gastric Bypass
Additional trial identifiers [1] 317905 0
Surgirack trial
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Morbid obesity 342852 0
Condition category
Condition code
Surgery 338964 338964 0 0
Surgical techniques
Diet and Nutrition 339104 339104 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is an alternatively designed method of storage of instruments during a laparoscopic Roux-en-Y gastric bypass. The Surgirack is a curved plastic instrument holder that clips to the drape overlying the patient during surgery. Each operation is approximately 2 hours in duration. The Surgirack or the standard instrument holder will be handled by the operating surgeon. Each operation will be video recorded to ensure adherence to the intervention. This will be a single surgeon study with cases randomised to Surgirack or standard instrument holder. The study will be led across 3 private hospital settings in Adelaide Australia. The private hospitals include Calvary North Adelaide, Burnside Hospital and Flinders Private Hospital. The operative steps, trocer placement, type and number of instruments is standardised for all cases.
Intervention code [1] 334752 0
Treatment: Devices
Description of the comparator or control
The control group will be the same duration for each operation approximately 2 hours. The control group will be laparoscopic Roux-en-Y gastric bypass with standard instrument holders rather than the Surgirack. Standard instrument holders are generic closed plastic tubes like a quiver. The type and number of laparoscopic instruments will remain the same. The location on the drapes and number of instrument holders (2) will also be standardised across both groups.
Control group
Active

Outcomes
Primary outcome [1] 346212 0
Difference in mean instrument exchange time (seconds), defined as the time from initiation of the exchange to successful placement of a new instrument in working position.
Timepoint [1] 346212 0
Each operation video will be analysed within 5 days of the surgery.
Secondary outcome [1] 465028 0
Total instrument exchange time for laparoscopic Roux-en-Y gastric bypass
Timepoint [1] 465028 0
All operation videos will be analysed within 5 days of the surgery.

Eligibility
Key inclusion criteria
• Elective laparoscopic Roux-en-Y gastric bypass
• Age 18 years or older
• Willingness and ability to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Concurrent hiatus hernia repair
• Refusal or inability to provide informed consent

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Random allocation will be performed by a web-based system called REDCap. Once a patient is consented and confirmed eligible the researcher logs into REDCap, clicks a button, and the system reveals the assignment. This creates an unchangeable audit trail.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Computer-generated random random sequence
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Continuous outcomes (e.g., mean exchange time) will be compared using independent samples t-tests or Mann-Whitney U tests if non-normally distributed. P-values below 0.05 will be considered significant. We powered the trial to detect a 10 minute difference in total instrument exchange time per case. Assuming an SD of paired differences of 12 minutes, a two-sided alpha=0.05 and 80% power require 15 paired cases.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
13/07/2026
Date of last participant enrolment
Anticipated
31/10/2026
Actual
Date of last data collection
Anticipated
6/11/2026
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
SA
Recruitment hospital [1] 29853 0
Flinders Private Hospital - Bedford Park
Recruitment hospital [2] 29854 0
Calvary North Adelaide Hospital - North Adelaide
Recruitment hospital [3] 29855 0
The Burnside War Memorial Hospital - Toorak Gardens
Recruitment postcode(s) [1] 46208 0
5042 - Bedford Park
Recruitment postcode(s) [2] 46209 0
5006 - North Adelaide
Recruitment postcode(s) [3] 46210 0
5065 - Toorak Gardens

Funding & Sponsors
Funding source category [1] 322439 0
Self funded/Unfunded
Name [1] 322439 0
Country [1] 322439 0
Primary sponsor type
Individual
Name
Jacob Chisholm Adelaide Bariatric Centre
Address
Country
Australia
Secondary sponsor category [1] 325366 0
Individual
Name [1] 325366 0
Alice Osterwalder Adelaide Bariatric Centre
Address [1] 325366 0
Country [1] 325366 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 320932 0
St Vincent's Hospital Melbourne Human Research Ethics Committee
Ethics committee address [1] 320932 0
Ethics committee country [1] 320932 0
Australia
Date submitted for ethics approval [1] 320932 0
06/07/2026
Approval date [1] 320932 0
10/07/2026
Ethics approval number [1] 320932 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 152122 0
Dr Alice Osterwalder
Address 152122 0
Adelaide Bariatric Centre 12 The Parade Norwood SA 5067
Country 152122 0
Australia
Phone 152122 0
+61 435142088
Fax 152122 0
Email 152122 0
[email protected]
Contact person for public queries
Name 152123 0
Alice Osterwalder
Address 152123 0
Adelaide Bariatric Centre 12 The Parade Norwood SA 5067
Country 152123 0
Australia
Phone 152123 0
+61 8 8177 1503
Fax 152123 0
Email 152123 0
[email protected]
Contact person for scientific queries
Name 152124 0
Alice Osterwalder
Address 152124 0
Adelaide Bariatric Centre 12 The Parade Norwood SA 5067
Country 152124 0
Australia
Phone 152124 0
+61 8 8177 1503
Fax 152124 0
Email 152124 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No


What supporting documents are/will be available?

TypeCitationLinkEmailOther DetailsAttachment
Ethical approval    2025.PID00482 Ethics approval.pdf
Informed consent form    PICF version 10 clean copy .docx
Study protocol    A Randomised Controlled Trial Comparing Laparoscopic Instrument Exchange Times Using the Surgirack version 6 clean copy.docx
Clinical study report    Appendix 3 version 2.docx


Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
AppendicesNo Appendix 1 version 2.docx
AppendicesNo Appendix 2 version 2.docx
AppendicesNo Appendix 3 version 2.docx
AppendicesNo Appendix 4 version 2.docx

Documents added automatically
No additional documents have been identified.