None listed
Conditions
Brief summary
In this study we will record on video laparoscopic gastric bypass procedures whilst using a new laparoscopic instrument holder, Surgirack. This device has been approved by the Therapeutic Goods Administration (TGA) which is the Australian government organisation tasked with making sure medical devices are safe. Surgirack has been used since January 2025 over 3000 times across 10 different hospitals and by 45 different surgeons within Adelaide. Surgirack has been used in laparoscopic gastric bypass close to 200 times since January 2025. We will also record laparoscopic gastric bypass using standard instrument holders. We will then compare the videos to see if there is a difference in instrument exchange time between the two different instrument holders. We believe that instrument exchange time is significantly reduced which would then reduce operating time.
Interventions
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
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.
Sponsors
Jacob Chisholm Adelaide Bariatric Centre
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
• Elective laparoscopic Roux-en-Y gastric bypass • Age 18 years or older • Willingness and ability to provide informed consent
Exclusion criteria
• Concurrent hiatus hernia repair • Refusal or inability to provide informed consent
Outcome results
None listed