Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000458437
Ethics application status
Approved
Date submitted
18/04/2025
Date registered
15/05/2025
Date last updated
15/05/2025
Date data sharing statement initially provided
15/05/2025
Type of registration
Retrospectively registered

Titles & IDs
Public title
Improving Access to Hernia Surgery: A Study of Same-Day Procedures in Public Hospitals
Scientific title
Same-Day Abdominal Wall and Groin Hernia Surgery in Adults: A Prospective Cohort Study Evaluating a Public Short-Stay Model
Secondary ID [1] 314242 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Groin Hernia 337159 0
Inguinal Hernia 337299 0
Abdominal wall hernia 337300 0
Condition category
Condition code
Surgery 333578 333578 0 0
Other surgery

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Participants underwent elective repair of abdominal wall or groin hernias (inguinal, femoral, umbilical, or ventral) through a dedicated short-stay hernia surgery service. This service represents the standard model of care at our institution and is not an intervention specific to the study. All eligible patients received either laparoscopic or open hernia repair as a planned same-day procedure, with admission and discharge occurring within the same calendar day.

The care pathway emphasized minimally invasive techniques and the use of intraoperative nerve blocks to facilitate early recovery and discharge. Patients were selected for this pathway based on predefined clinical criteria, including age between 18 and 75 years, body mass index (BMI) under 40, and a low burden of comorbidities.

Participation in the study involved no deviation from standard care. Data were collected as part of routine clinical follow-up at 4 weeks and 12 months postoperatively to assess surgical complications and patient-reported quality of life.
Intervention code [1] 330853 0
Not applicable
Comparator / control treatment
There was no formal control group. Outcomes were compared against published benchmarks and historical standards for inpatient hernia repair, including rates of complications, failed same-day discharge, and quality-of-life outcomes. The performance of the same-day hernia service was evaluated in the context of existing literature and guideline targets for same-day surgical care.
Control group
Uncontrolled

Outcomes
Primary outcome [1] 341150 0
Same-day discharge rate
Timepoint [1] 341150 0
Day of surgery
Primary outcome [2] 341151 0
Postoperative complications
Timepoint [2] 341151 0
Clinical review completed on day of surgery
Primary outcome [3] 341152 0
Quality of life improvement
Timepoint [3] 341152 0
Baseline, 4 weeks, and 12 months post-operation
Secondary outcome [1] 446511 0
Readmission rate
Timepoint [1] 446511 0
Within 30 days post-operation
Secondary outcome [2] 446512 0
Reoperation rate
Timepoint [2] 446512 0
Reoperation rate from surgical records collected until 12 months post-operation.
Secondary outcome [3] 446513 0
Pain scores
Timepoint [3] 446513 0
At 1 week and 4 weeks post-operation
Secondary outcome [4] 446514 0
Return to normal activity/work
Timepoint [4] 446514 0
4 weeks and 12 months post-operation
Secondary outcome [5] 446515 0
Cost-effectiveness
Timepoint [5] 446515 0
After completion of cohort follow-up (12 months)

Eligibility
Key inclusion criteria
• Adults aged 18 to 75 years
• Diagnosed with an uncomplicated abdominal wall or groin hernia (inguinal, femoral, umbilical, or small ventral hernia)
• ASA Physical Status I–II
• BMI < 40
• Medically suitable for same-day discharge based on anaesthetic assessment
• Able to understand and consent to surgery and follow-up
• Social supports in place to facilitate recovery at home post-discharge
Minimum age
18 Years
Maximum age
75 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
• Age > 75 years
• Complex hernias (e.g., recurrent, strangulated, incarcerated, or requiring mesh explant)
• ASA Physical Status IIIb or higher
• BMI > or = 40
• Significant comorbidities requiring inpatient monitoring (e.g., unstable cardiovascular or respiratory disease, insulin-dependent diabetes with complications)
• Requirement for anticoagulation therapy that cannot be safely managed perioperatively
• Inadequate social support at home post-discharge
• Inability to understand study procedures or comply with follow-up
• Patients undergoing concurrent procedures or requiring overnight admission for other clinical reasons

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis
1. Descriptive Statistics:
• Continuous variables (e.g., age, BMI, ASA score, operation time) will be described using mean (standard deviation) or median (interquartile range), depending on the data distribution.
• Categorical variables (e.g., gender, hernia type, complication rates) will be reported as frequencies and percentages.
2. Primary Outcome Analysis:
• The rate of failed same-day discharge will be assessed using binomial proportion. Confidence intervals (CI) will be calculated.
• A chi-squared test or Fisher’s exact test will be used to compare proportions between groups (e.g., laparoscopic vs. open repairs).
3. Secondary Outcome Analysis:
• Readmission rate, reoperation rate, and pain scores will be compared using chi-squared tests (for categorical outcomes) and Mann-Whitney U tests or t-tests (for continuous outcomes) between different surgical approaches (laparoscopic vs. open).
• Quality-of-life scores (EuraHS-QoL Scale) will be analyzed using paired t-tests or Wilcoxon signed-rank tests for changes from baseline to 1-week, 1-month, and 3-month follow-up.
• Cost-effectiveness will be assessed using descriptive cost analysis and cost per outcome (same-day discharge, complications, etc.).
4. Multivariable Analysis:
• Logistic regression will be used to determine independent predictors of failed same-day discharge and complications (age, BMI, ASA score, type of hernia, surgical approach).
• Kaplan-Meier survival analysis will be performed for time-to-event outcomes such as reoperation or readmission, with differences assessed using the log-rank test.
5. Statistical Significance:
• A p-value of < 0.05 will be considered statistically significant for all tests.
• Data will be analyzed using RStudio, version 2024.09 or SPSS (depending on availability).
6. Handling Missing Data:
• Missing data will be handled using multiple imputation for continuous variables and last observation carried forward for categorical outcomes.
7. Sensitivity Analysis:
• Sensitivity analyses will be performed for the primary and secondary outcomes to check the robustness of the results under different assumptions or data handling methods.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
1/09/2023
Date of last participant enrolment
Anticipated
1/09/2026
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
352
Accrual to date
33
Final
Recruitment in Australia
Recruitment state(s)
NSW

Funding & Sponsors
Funding source category [1] 318763 0
Hospital
Name [1] 318763 0
Canterbury Hospital
Country [1] 318763 0
Australia
Primary sponsor type
Hospital
Name
Canterbury Hospital
Address
Country
Australia
Secondary sponsor category [1] 321203 0
None
Name [1] 321203 0
Address [1] 321203 0
Country [1] 321203 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 317373 0
Sydney Local Health District HREC – Concord Repatriation General Hospital
Ethics committee address [1] 317373 0
Ethics committee country [1] 317373 0
Australia
Date submitted for ethics approval [1] 317373 0
01/03/2023
Approval date [1] 317373 0
01/04/2023
Ethics approval number [1] 317373 0

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

Contacts
Principal investigator
Name 140850 0
Dr Sergei Tsakanov
Address 140850 0
General Surgery Department, Canterbury Hospital, 575 Canterbury Rd, Campsie NSW 2194
Country 140850 0
Australia
Phone 140850 0
+61 2 9787 0000
Fax 140850 0
Email 140850 0
[email protected]
Contact person for public queries
Name 140851 0
Pratik Raichurkar
Address 140851 0
General Surgery Department, Canterbury Hospital, 575 Canterbury Rd, Campsie NSW 2194
Country 140851 0
Australia
Phone 140851 0
+61 2 9787 0000
Fax 140851 0
Email 140851 0
[email protected]
Contact person for scientific queries
Name 140852 0
Pratik Raichurkar
Address 140852 0
General Surgery Department, Canterbury Hospital, 575 Canterbury Rd, Campsie NSW 2194
Country 140852 0
Australia
Phone 140852 0
+61 2 9787 0000
Fax 140852 0
Email 140852 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: No, individual participant data will not be shared as part of this study.



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.