Trial Review

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
ACTRN12610000031066
Ethics application status
Approved
Date submitted
14/12/2009
Date registered
12/01/2010
Date last updated
12/01/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Prospective Randomized Trial of Laparoscopic Totally Extraperitoneal (TEP) Inguinal Hernioplasty with Partially Absorbable Light Weight Mesh versus Multifilament Polyester Anatomical Mesh
Scientific title
Prospective Randomized Trial comparing the mesh manipulating time of Laparoscopic Totally Extraperitoneal (TEP) Inguinal Hernioplasty with Partially Absorbable Light Weight Mesh versus Multifilament Polyester Anatomical Mesh
Secondary ID [1] 1206 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal hernia 252389 0
Condition category
Condition code
Surgery 256571 256571 0 0
Surgical techniques
Oral and Gastrointestinal 256590 256590 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
In this study, the surgical handling and clinical outcome of two totally different meshes use for laparoscopic inguinal hernia repair is compared. One is constructed with non-absorbable polypropylene (Prolene) mixed with an absorbable material poliglecaprone 25 (Monocryl) in a single sheet form. (ULTRAPROT, Ethicon Inc., manufactured by Johnson & Johnson Company) The other mesh we compare is a polyester multifilament mesh constructed in an anatomical form to fit the inguinal canal. (PARIETEXT polyester mesh, Tyco Healthcare Ltd., manufactured by Sofradim Production). Both types of mesh are applied by laparoscopic means into the extraperitoneal space permanently.

The approximate duration of the procedure is 60-120 minutes. The primary endpoint is the mesh manipulating time;l therefore, the duration of procedure will be affected by the type of mesh used
Intervention code [1] 255693 0
Treatment: Surgery
Comparator / control treatment
ULTRAPRO mesh vs. PARIETEX mesh
Control group
Active

Outcomes
Primary outcome [1] 257462 0
The primary endpoints were mesh manipulating time. This is measured from the time the mesh is inserted via the laparoscopic port to the time when it is snugly placed
Timepoint [1] 257462 0
intraoperatively
Secondary outcome [1] 262636 0
hernia recurrence rate

outcome assessed by clinical examination
Timepoint [1] 262636 0
2 weeks, 6 months, 1 year, 2 years, 3 years after the date of operation
Secondary outcome [2] 262660 0
perioperative complication rate

such as seroma, hematoma, wound infection, chronic pain, recurrence

assessed during clinical follow up
Timepoint [2] 262660 0
2 weeks, 6 months, 1 year, 2 years, 3 years after the date of operation
Secondary outcome [3] 262661 0
length of hospital stay, measured by total number of days for hospital stay
Timepoint [3] 262661 0
during hospital stay
Secondary outcome [4] 262662 0
number of days required to resume normal outdoor activities and work

patient will be asked about the time he/she resumed normal outdoor activities during follow ups
Timepoint [4] 262662 0
during early postoperative period, 2 weeks, 6 months after the date of operation
Secondary outcome [5] 262663 0
incidence of chronic post-operative neuralgia

outcome measured by number of occurrence during follow up
Timepoint [5] 262663 0
2 weeks, 6 months, 1 year, 2 years, 3 years after the date of operation

Eligibility
Key inclusion criteria
1. Age 18 to 80 years
2. Medical fitness for general anesthesia
3. Suitability for laparoscopic TEP repair
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Not suitable for laparoscopic inguinal hernia repair
2. Not suitable for general anaesthesia
3. Suspected sliding hernia
4. Lower abdominal scar over operative region
5. On anticoagulant
6. Bleeding diathesis
7. Chronic liver disease with ascites or portal hypertension

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)
The randomization will be done just before the surgery by sealed opaque envelopes.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sealed opaque envelopes containing type of mesh to be used will be generated by clerical staff not involved in this study. Simple randomisation is done by using a randomisation table created by a computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/12/2009
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 2365 0
Hong Kong
State/province [1] 2365 0

Funding & Sponsors
Funding source category [1] 256176 0
Hospital
Name [1] 256176 0
Pamela Youde Nethersole Eastern Hospital
Country [1] 256176 0
Hong Kong
Primary sponsor type
Individual
Name
Dr. Tony Cheung
Address
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan
Hong Kong
postal code: n/a
Country
Hong Kong
Secondary sponsor category [1] 251516 0
Individual
Name [1] 251516 0
Dr. George Yang
Address [1] 251516 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan,
Hong Kong
postal code: n/a
Country [1] 251516 0
Hong Kong

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 258280 0
Ethics Committee, Hong Kong East Cluster, Hospital Authority
Ethics committee address [1] 258280 0
3 Lok Man Road,
Chai Wan
Hong Kong
postal code: n/a
Ethics committee country [1] 258280 0
Hong Kong
Date submitted for ethics approval [1] 258280 0
Approval date [1] 258280 0
18/11/2009
Ethics approval number [1] 258280 0

Summary
Brief summary
This study is performed to compare the two types of mesh commonly used in laparoscopic hernia repair.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 30615 0
Address 30615 0
Country 30615 0
Phone 30615 0
Fax 30615 0
Email 30615 0
Contact person for public queries
Name 13862 0
Dr. Tony Cheung
Address 13862 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan,
Hong Kong
postal code: n/a
Country 13862 0
Hong Kong
Phone 13862 0
(852)2595-6111
Fax 13862 0
Email 13862 0
[email protected]
Contact person for scientific queries
Name 4790 0
Dr. Tony Cheung
Address 4790 0
Department of Surgery
Pamela Youde Nethersole Eastern Hospital
3 Lok Man Road, Chai Wan,
Hong Kong
postal code: n/a
Country 4790 0
Hong Kong
Phone 4790 0
(852)2595-6111
Fax 4790 0
Email 4790 0
[email protected]

No information has been provided regarding IPD availability


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
SourceTitleYear of PublicationDOI
Dimensions AIProspective randomized controlled trial comparing partially absorbable lightweight mesh and multifilament polyester anatomical mesh in laparoscopic inguinal hernia repair2017https://doi.org/10.1111/ases.12421
N.B. These documents automatically identified may not have been verified by the study sponsor.