Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000544370
Ethics application status
Approved
Date submitted
12/10/2008
Date registered
28/10/2008
Date last updated
4/07/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of life quality between patients undergoing modified primary closure and retromuscular mesh repair for abdominal incisional hernia.
Scientific title
The prospective randomized trial comparing the components separation technique with retromuscular prosthetic mesh repair in patients with incisional hernia regarding the quality of life.
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Incisional hernia 3875 0
Condition category
Condition code
Surgery 4075 4075 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The abdominal incisional hernias placed in the midline will be grouped into two. In the stidy group the components separation technique will be used. After surgical reduction of the hernia, the healthy fascial edges will be isolated. Then a wide skin flap will be raised on both sides of the midline incision. The lateral edge of the rectus muscle will be identified. An incision will be done to the external oblique fascia through the length of the original incision just lateral to the lateral border of the rectus bundle, protecting the Spigel line. The incision which will be deepened just under the external oblique muscle fibers sparing the underlying internal oblique and transversus abdominis muscles. The plane between the external and internal oblique muscles will be advanced through the whole length upto the level of the midaxillary line. This procedure will be repeated for the contralateral side. The healthy medial fascial edges of the rectus muscles will be approximated using polypropylene continuous sutures.
Intervention code [1] 3603 0
Treatment: Surgery
Comparator / control treatment
Active control. In the retromuscular mesh repair technique, after reduction of the hernial sac a plane will be formed under the rectus muscles upto the lateral edge of the muscle bundle. The same procedure will be applied to the other side. Then a large piece of polypropylene mesh sized at least 5 cm longer than the hernial defect on all sides will be placed under the rectus muscles. The edges of the mesh will be fixed to the overlying fascia by 8-10 all-layers polypropylene sutures (placed about 10 cm.s apart) which will be tied over the fascia and under the skin. The overlying midline fascia will be closed after isolating the healthy edges.
Control group
Active

Outcomes
Primary outcome [1] 4905 0
Freedom of movement during daily activities as coded in three grades; no restriction, somehow restricting and overt-full restriction.
Timepoint [1] 4905 0
1 month, 6 month, 12 month, 2 years
Primary outcome [2] 4972 0
Pain as measured by the numeric rating scale. The scale consists of a horizontal line and numbers through 0 to 10 placed at equal intervals on top of the line. The patient is asked to point the level of pain experienced during rest and movement with the tip of a pen (0 no pain, 10 maximum imaginable pain).
Timepoint [2] 4972 0
1 month, 6 month, 12 month, 2 years
Primary outcome [3] 4973 0
Quality of Life as measured by SF-36. The SF-36 form is a multipurpose health assessing form consisting of 6 domains. The participant will reply to the queries personally or with the help of the accompanying person when she/he is invited for examination at the specified timepoints.
Timepoint [3] 4973 0
1 month, 6 month, 12 month, 2 years
Secondary outcome [1] 8285 0
Hernia recurrence. This will be assessed by physical examination on the specified timepoints. If there is a doubt with the examination, computerized tomography will be performed.
Timepoint [1] 8285 0
1 month, 6 month, 12 month, 2 years
Secondary outcome [2] 8388 0
All postoperative complications including surgical site infection, wound dehiscence and mortality. These will be assessed on follow-up visits by examining the patient and the wound. Mortality is assessed by the hospital records or by interviewing the relatives.
Timepoint [2] 8388 0
1 month, 6 month, 12 month, 2 years

Eligibility
Key inclusion criteria
All patients accepting the procedure who have abdominal midline incisional hernias.
Minimum age
16 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with off-midline incisional hernias and not accepting to be included in the study.

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)
Consecutive patients will be explained regarding the procedures and will be assigned one or the other method if they agree to participate. Allocation concealment will be by contacting the holder of the allocation schedule who was “off-site”.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Blocked ranked randomization method will be used. Random seed generator of the computer software will be the source of the sequence.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/04/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 1260 0
Turkey
State/province [1] 1260 0

Funding & Sponsors
Funding source category [1] 4061 0
University
Name [1] 4061 0
Baskent University
Country [1] 4061 0
Turkey
Primary sponsor type
University
Name
Baskent University
Address
1. Cadde 16. Sokak No:11 06490 Bahçelievler / ANKARA
Country
Turkey
Secondary sponsor category [1] 3671 0
None
Name [1] 3671 0
Address [1] 3671 0
Country [1] 3671 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6137 0
Baskent University Ethics Committee
Ethics committee address [1] 6137 0
Ethics committee country [1] 6137 0
Turkey
Date submitted for ethics approval [1] 6137 0
Approval date [1] 6137 0
Ethics approval number [1] 6137 0

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

Contacts
Principal investigator
Name 29029 0
Address 29029 0
Country 29029 0
Phone 29029 0
Fax 29029 0
Email 29029 0
Contact person for public queries
Name 12186 0
Tarik Zafer Nursal
Address 12186 0
Gürselpasa Mah. Mavi Bulvar No:133/2 Senbayrak Sitesi B-Blok Seyhan / Adana
Country 12186 0
Turkey
Phone 12186 0
+905327763645
Fax 12186 0
Email 12186 0
[email protected]
Contact person for scientific queries
Name 3114 0
Tarik Zafer Nursal
Address 3114 0
Gürselpasa Mah. Mavi Bulvar No:133/2 Senbayrak Sitesi B-Blok Seyhan / Adana
Country 3114 0
Turkey
Phone 3114 0
+905327763645
Fax 3114 0
Email 3114 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
No additional documents have been identified.