Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12605000725662
Ethics application status
Approved
Date submitted
7/10/2005
Date registered
11/11/2005
Date last updated
1/06/2024
Date data sharing statement initially provided
24/09/2019
Date results information initially provided
24/09/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Multicentre Randomised Controlled Trial of Laparoscopic Suture vs Mesh for Effective Repair of Large Hiatus Hernia
Scientific title
Multicentre Randomised Controlled Trial of Laparoscopic Suture vs Mesh for Effective Repair of Large Hiatus Hernia
Secondary ID [1] 287836 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hiatus herna 876 0
Condition category
Condition code
Oral and Gastrointestinal 944 944 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Surgery 945 945 0 0
Other surgery

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Laparoscopic surgical repair - sutures alone vs absorbable Biomesh vs non-absorbable Timesh
Intervention code [1] 702 0
Treatment: Surgery
Comparator / control treatment
2 surgical variants compared in RCT
Control group
Active

Outcomes
Primary outcome [1] 1242 0
Integrity of hiatus hernia repair.
Timepoint [1] 1242 0
Measured by Barium meal X-ray at 6 months and 3 yrs, and by clinical follow-up - yearly for up to 20 years.
Secondary outcome [1] 2260 0
Clinical recurrence of the hernia.
Timepoint [1] 2260 0
Follow-up for 20 years
Secondary outcome [2] 2261 0
The development of post-operative reflux.
Timepoint [2] 2261 0
Follow-up for 20 years
Secondary outcome [3] 2262 0
The development of post-operative side effects.
Timepoint [3] 2262 0
Follow-up for 20 years
Secondary outcome [4] 2263 0
Overall satisfaction with the surgical outcome.
Timepoint [4] 2263 0
Follow-up for 20 years

Eligibility
Key inclusion criteria
Large hiatus hernia (more than 50% of stomach in the chest)Laparoscopic surgical repair clinically indicatedFit for surgery.
Minimum age
18 Years
Maximum age
Not stated
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No informed consent.Previous surgery for gastro-oesophageal reflux or repair for hiatus herniaPregnant.

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)
Sealed envelope - only opened once surgery has commenced
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
200 envelopes will be prepared, containing equal numbers of each allocation. They will be shuffled, and then randomly selected from the pile of envelopes. There will be no stratification.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/11/2005
Actual
1/02/2006
Date of last participant enrolment
Anticipated
Actual
1/09/2012
Date of last data collection
Anticipated
1/02/2026
Actual
Sample size
Target
129
Accrual to date
Final
126
Recruitment in Australia
Recruitment state(s)
SA

Funding & Sponsors
Funding source category [1] 1042 0
Government body
Name [1] 1042 0
NHMRC grant
Country [1] 1042 0
Australia
Primary sponsor type
Hospital
Name
Dept of Surgery at Flinders Medical Centre
Address
Bedford Park, SA
Country
Australia
Secondary sponsor category [1] 904 0
None
Name [1] 904 0
No secondary sponsorship
Address [1] 904 0
Country [1] 904 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 2341 0
Flinders Medical Centre
Ethics committee address [1] 2341 0
Bedford Park, SA 5042
Ethics committee country [1] 2341 0
Australia
Date submitted for ethics approval [1] 2341 0
Approval date [1] 2341 0
01/02/2006
Ethics approval number [1] 2341 0
Ethics committee name [2] 2342 0
Royal Adelaide Hospital
Ethics committee address [2] 2342 0
Port Road, Adelaide, SA, 5000
Ethics committee country [2] 2342 0
Australia
Date submitted for ethics approval [2] 2342 0
Approval date [2] 2342 0
01/02/2006
Ethics approval number [2] 2342 0

Summary
Brief summary
In a multicentre prospective double-blinded randomized trial, we will compare 3 laparoscopic methods for the repair of large hiatus hernia
a) Repair using either sutures alone
b) Repair with Biomesh (absorbable)
c) Repair with Timesh (non-absorbable).
to determine:
1) Short term and long term effectiveness of the hernia repair
2) Risk of postoperative side effects

This trial will test the hypothesis that there is no difference in the incidence of recurrent hiatus hernia for the 3 different techniques of repair of large hiatus hernia. The primary outcome will be the integrity of the hiatal repair assessed by barium meal X-ray. Secondary outcomes will include clinical recurrence of the hernia, the development of post-operative reflux, the development of post-operative side effects, and overall satisfaction with the surgical outcome.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 35131 0
Prof David Watson
Address 35131 0
Dept Surgery
Flinders University
Country 35131 0
Australia
Phone 35131 0
+61882046086
Fax 35131 0
Email 35131 0
david.watson@flinders.edu.au
Contact person for public queries
Name 9891 0
Prof Professor David Watson
Address 9891 0
Department of Surgery
Flinders University
Flinders Medical Centre
Bedford Park SA 5042
Country 9891 0
Australia
Phone 9891 0
+61 8 82046086
Fax 9891 0
Email 9891 0
david.watson@flinders.edu.au
Contact person for scientific queries
Name 819 0
Prof Professor David Watson
Address 819 0
Department of Surgery
Flinders University
Flinders Medical Centre
Bedford Park SA 5042
Country 819 0
Australia
Phone 819 0
+61 8 82046086
Fax 819 0
Email 819 0
david.watson@flinders.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Study results articleYes Watson DI, Thompson SK, Devitt PG, Smith L, Woods ... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseFive Year Follow-up of a Randomized Controlled Trial of Laparoscopic Repair of Very Large Hiatus Hernia With Sutures Versus Absorbable Versus Nonabsorbable Mesh.2020https://dx.doi.org/10.1097/SLA.0000000000003734
EmbaseQuality of Life Following Repair of Large Hiatal Hernia is Improved but not Influenced by Use of Mesh: Results From a Randomized Controlled Trial.2015https://dx.doi.org/10.1007/s00268-015-2970-3
Dimensions AILong-term outcomes of revisional surgery following laparoscopic fundoplication2009https://doi.org/10.1002/bjs.6486
N.B. These documents automatically identified may not have been verified by the study sponsor.