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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001116314
Ethics application status
Help: Ethics application status
Approved
Date submitted
Help: Date submitted
24/08/2026
Date registered
Help: Date registered
9/09/2026
Date last updated
Help: Date last updated
9/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
9/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
Does reinforced tension line closure of abdominal incision reduce incisional hernias after liver transplantation? A randomised controlled trial
Scientific title
Reinforced tension line closure versus conventional fascial closure for prevention of incisional hernia after liver transplantation: a randomised controlled trial
Additional trial identifiers [1] 318317 0
nil known
Universal Trial Number (UTN)
Trial acronym
RTL-LT
Related trial records

Health condition
Health condition(s) studied:
Incisional Hernia 343147 0
Liver Transplantation 343448 0
Condition category
Condition code
Surgery 339408 339408 0 0
Surgical techniques
Oral and Gastrointestinal 339541 339541 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
The intervention is - Reinforced tension line suture closure of the abdominal fascia (description below)

Intervention Group:
- Reinforced tension line closure suture
o 5mm of fascia exposed on either side.
o “the reinforced tension suture”- Longitudinal suture using 2-0 PDS placed 3-5mm away from fascial edge on either side and each suture bite 10mm apart.
- The parallel RTL suture will go through both anterior sheath and posterior sheath (avoiding the muscle) in a midline closure (on either side of the fascia)
- In the transverse component of the wound – we will perform a two layered closure
o we will utilise a parallel RTL suture for the posterior sheath first (on either side of the fascia). Once the posterior sheath/muscle of the transverse component is closed we will move onto closure of anterior sheath/muscle with another parallel RTL suture ( on each side)
- Followed by continuous closure of fascia with 2 x 0 PDS suture with 5-10mm bites of fascial edge, with 5-10mm between each suture ensure sutures go beyond the longitudinal reinforced suture line

This will be performed by the Liver Transplant surgeon for all recruited patients undergoing Liver Transplantation.

We will review operative notes to monitor adherence .
Intervention code [1] 334986 0
Treatment: Surgery
Description of the comparator or control
Control - Conventional suture closure (description below)

Control Group:
- Standard abdominal closure
o 5mm of fascia exposed on either side
o 2 x Suture - 0 or 1 PDS (polydioxanone), loop or single
o Continuous closure of fascia with 5-10mm bites of fascial edge, with 5-10mm distance between each suture.
o Using 4:1 suture to wound ratio for suture length.

We will review operative notes to monitor adherence
Control group
Active

Outcomes
Primary outcome [1] 346616 0
Incisional hernia rate at 12 months
Timepoint [1] 346616 0
This will be assessed at 12 month follow up
Secondary outcome [1] 466758 0
Rate of wound complications
Timepoint [1] 466758 0
Post operative - within 30 days.
Secondary outcome [2] 466760 0
Post operative morbidity/mortality using Clavien-Dindo Classification
Timepoint [2] 466760 0
This will be assessed within 90 days post-operation
Secondary outcome [3] 466761 0
Length of stay
Timepoint [3] 466761 0
Period of hospital stay from date of operation to date of discharge measured in days
Secondary outcome [4] 466762 0
Fascial closure duration
Timepoint [4] 466762 0
- from start of intervention (or control) to end of intervention - measured in minutes
Secondary outcome [5] 466763 0
Patient reported outcomes / quality of life
Timepoint [5] 466763 0
Pre operative ( baseline), 1 month post-operative follow up and 12 month post-operative follow up
Secondary outcome [6] 466764 0
Feasibility study (internal pilot )
Timepoint [6] 466764 0
6 month and 12 month review post commencement of recruitment

Eligibility
Key inclusion criteria
All patients undergoing liver transplantation for any indication

Participants need to have ability to provide consent or have a person responsible willing to consent. They must be willing to participate and comply with study requirements
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Healthy volunteers
No
Key exclusion criteria
• Patients with open abdomen – i.e fascia not closed at time of surgery

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)
Patients will be randomised to intervention or control group after the Liver Transplant Surgery has commenced. If decision is made to proceed with abdominal closure then patient will be randomised using REDCap to either group by the research team . The proposed intervention (or control) will be allocated to patient and disclosed to the treating surgeon who will perform the technique.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permutated block randomisation and risk stratification using REDCap
Risk factors used for stratification - presence of diabetes mellitus (yes/no) and BMI (30)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Expected numbers will be approximately 256 patients (based on sample size calculation)
• Using 30% as the baseline hernia rate, and the estimated hernia rate of 15% after intervention, using alpha at 0.05 and with 80% power, the samples size required is 121 per arm and 242 for both arms. Considering a 5% dropout rate, the required sample size is 128 per arm and 256 for two arms.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
14/09/2026
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
256
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 29956 0
Royal Prince Alfred Hospital - Camperdown
Recruitment postcode(s) [1] 46320 0
2050 - Camperdown

Funding & Sponsors
Funding source category [1] 322574 0
Hospital
Name [1] 322574 0
Royal Prince Alfred Hospital
Country [1] 322574 0
Australia
Primary sponsor type
Government body
Name
Sydney Local Health District
Address
Country
Australia
Secondary sponsor category [1] 325721 0
None
Name [1] 325721 0
Address [1] 325721 0
Country [1] 325721 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 321046 0
Sydney Local Health District Ethics Review Committee (RPAH Zone)
Ethics committee address [1] 321046 0
Ethics committee country [1] 321046 0
Australia
Date submitted for ethics approval [1] 321046 0
23/03/2026
Approval date [1] 321046 0
19/08/2026
Ethics approval number [1] 321046 0
X26-0164 & 2026/ETH00634

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

Contacts
Principal investigator
Name 152486 0
A/Prof Michael Crawford
Address 152486 0
Royal Prince Alfred Hospital, 50 Missenden Road, Camperdown, NSW, 2050
Country 152486 0
Australia
Phone 152486 0
+61 295158226
Fax 152486 0
Email 152486 0
[email protected]
Contact person for public queries
Name 152487 0
Ms Susan Virtue
Address 152487 0
Royal Prince Alfred Hospital, 50 Missenden Road, Camperdown, NSW, 2050
Country 152487 0
Australia
Phone 152487 0
+61 295158226
Fax 152487 0
Email 152487 0
[email protected]
Contact person for scientific queries
Name 152488 0
Dr Arsalan Bakhtiar
Address 152488 0
Royal Prince Alfred Hospital, 50 Missenden Road, Camperdown, NSW, 2050
Country 152488 0
Australia
Phone 152488 0
+61 295158226
Fax 152488 0
Email 152488 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.