Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000238471
Ethics application status
Approved
Date submitted
16/11/2024
Date registered
2/04/2025
Date last updated
2/04/2025
Date data sharing statement initially provided
2/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
Gas Assessment of Surgical Leaks in Enteric Anastomoses (GAS-LEAk)
Scientific title
Implementation of a gas-based anastomotic leak sensor in patients undergoing intra-abdominal surgery
Secondary ID [1] 313387 0
None
Universal Trial Number (UTN)
Trial acronym
GAS-LEAk
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Anastomotic leak 335760 0
Condition category
Condition code
Surgery 332317 332317 0 0
Other surgery
Oral and Gastrointestinal 333169 333169 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placement of a gas-based anastomotic leak sensor drain at the time of surgery (taking approximately 5 minutes of operative time), with monitoring of intraperitoneal gas levels for up to 7 days postoperatively, after which point the drain will be removed. The drain tubing will be placed inside the abdomen, and connected to a small, portable, external gas sensor. Research staff will monitor participants postoperative progress during the study with twice daily clinical review. There is no difference in the intervention between participants recruited in Stage 1 and Stage 2A.
Intervention code [1] 329969 0
Early detection / Screening
Intervention code [2] 330550 0
Treatment: Surgery
Comparator / control treatment
No control group will be used.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 339896 0
Changes in intraperitoneal concentrations of intestinal gases
Timepoint [1] 339896 0
Continuous monitoring over the first 7 days postoperatively
Secondary outcome [1] 441832 0
Drain Site Pain
Timepoint [1] 441832 0
Daily assessment while the drain is in situ
Secondary outcome [2] 441833 0
Drain Site Infection
Timepoint [2] 441833 0
Daily assessment while the drain is in situ
Secondary outcome [3] 441834 0
Drain Dislodgement
Timepoint [3] 441834 0
Daily assessment while the drain is in situ
Secondary outcome [4] 441835 0
Anastomotic Leak
Timepoint [4] 441835 0
In-hospital, 30-days, and 90-days postoperatively
Secondary outcome [5] 441837 0
Overall postoperative complications (e.g. pneumonia, acute kidney injury, wound infection)
Timepoint [5] 441837 0
In hospital, 30-days, and 90-days postoperatively
Secondary outcome [6] 444939 0
Intraabdominal collection
Timepoint [6] 444939 0
In hospital, 30 days, and 90-days postoperatively
Secondary outcome [7] 444940 0
Perceived comfort of the drain sensor
Timepoint [7] 444940 0
At discharge from hospital
Secondary outcome [8] 444943 0
Perceived safety of the drain sensor
Timepoint [8] 444943 0
At time of discharge from hospital

Eligibility
Key inclusion criteria
• Adult patients aged 18 years and over
• Undergoing intrabdominal surgery via either open or laparoscopic approach
o No bowel resection or anastomosis (Stage 1 only)
o Any colonic anastomosis, including ileocolic, colocolic, colorectal, or coloanal (Stage 2A only), with or without diverting ileostomy formation
• Able to give informed consent
• Able to understand the risks/benefit of the study
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
• Inability to give informed consent
• Patient refusal
• Aged <18 years
• Pregnancy
• Active infection of abdominal wall
• Known allergy to silicone
• Expected hospital discharge on same day as surgery

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
3/05/2025
Actual
Date of last participant enrolment
Anticipated
30/01/2027
Actual
Date of last data collection
Anticipated
1/05/2027
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 26732 0
New Zealand
State/province [1] 26732 0
Auckland

Funding & Sponsors
Funding source category [1] 317828 0
Government body
Name [1] 317828 0
Ministry of Business, Employment and Innovation
Country [1] 317828 0
New Zealand
Funding source category [2] 317831 0
Government body
Name [2] 317831 0
Health Research Council of New Zealand
Country [2] 317831 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 320164 0
None
Name [1] 320164 0
None
Address [1] 320164 0
Country [1] 320164 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316515 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 316515 0
Ethics committee country [1] 316515 0
New Zealand
Date submitted for ethics approval [1] 316515 0
25/11/2024
Approval date [1] 316515 0
15/01/2025
Ethics approval number [1] 316515 0

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

Contacts
Principal investigator
Name 138126 0
Prof Greg O'Grady
Address 138126 0
Department of Surgery, University of Auckland, Building 507, 22-30 Park Avenue, Auckland 1023, New Zealand
Country 138126 0
New Zealand
Phone 138126 0
+64274222989
Fax 138126 0
Email 138126 0
[email protected]
Contact person for public queries
Name 138127 0
Dr Cameron Wells
Address 138127 0
Department of Surgery, University of Auckland, Building 507, 22-30 Park Avenue, Auckland 1023, New Zealand
Country 138127 0
New Zealand
Phone 138127 0
+64 272448516
Fax 138127 0
Email 138127 0
[email protected]
Contact person for scientific queries
Name 138128 0
Dr Cameron Wells
Address 138128 0
Department of Surgery, University of Auckland, Building 507, 22-30 Park Avenue, Auckland 1023, New Zealand
Country 138128 0
New Zealand
Phone 138128 0
+64 272448516
Fax 138128 0
Email 138128 0
[email protected]

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


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.