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Trial registered on ANZCTR


Registration number
ACTRN12612000793819
Ethics application status
Approved
Date submitted
20/07/2012
Date registered
27/07/2012
Date last updated
16/08/2012
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparative Study Between Lichtenstein Procedure and Modified Darn Repair in Treating Primary Inguinal Hernia. A Prospective Randomized Controlled Trial.
Scientific title
Comparative Study Between Chronic Post Operative Pain after Lichtenstein Procedure versus Modified Darn Repair in Treating Primary Inguinal Hernia in Adult Males. A Prospective Randomized Controlled Trial.
Secondary ID [1] 280888 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
primary inguinal hernia 286958 0
Condition category
Condition code
Surgery 287297 287297 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Modified darn repair:
The procedure started by taking the first stitch on the pubic tubercle using O polypropylene. The thread was passed through the inguinal ligament and the internal oblique fascia fibres in a continuous tension free manner. Suturing was proceeded from medial to lateral in a crisscross pattern with 1 cm interval between each suture. On reaching the cord at the deep ring, care was taken to pass the sutures around the cord with no pressure, then the sutures are ligated 2-3 cm lateral to the deep ring. Security sutures (2-O monofilament polypropylene) were taken in a continuous manner starting at the pubic tubercle and passing through the edges of the repair at the inguinal ligament and the internal oblique fascia fibres and through the loops of the previous sutures. Procedure duration is about (60 - 120 minutes)
Intervention code [1] 285320 0
Treatment: Surgery
Comparator / control treatment
Lichtenstein procedure; polypropylene mesh is applied over the fascia transversalis after herniotomy and narrowing of the deep ring. mesh is then fixed to pubic tubercle, internal blique fascia fibres and inguinal ligament. laterally, a small openning is made in the mesh through which the cord passes then the mesh is resutured laterally to create another deep ring. Procedure duration is about (60 - 120 minutes)
Control group
Active

Outcomes
Primary outcome [1] 287572 0
chronic post operative pain
Timepoint [1] 287572 0
base line, then at 3,6, and 12 months post operatively, measured by Visual Analogue Scale
Primary outcome [2] 287573 0
recurrence
Timepoint [2] 287573 0
at 3,6, and 12 months post operatively, measured by clinical examination
Secondary outcome [1] 298428 0
operative time
Timepoint [1] 298428 0
intraoperative measured by time (minutes)
Secondary outcome [2] 298429 0
time to return to domestic and work activity
Timepoint [2] 298429 0
at 14 dayes post operative, measured by time (days)

Eligibility
Key inclusion criteria
male patients with primary inguinal hernia classified as Gilbert III or IV
Minimum age
18 Years
Maximum age
60 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
patients with complicated hernia, and or with persistant predisposing factor of hernia (chronic cough or ascites,...etc) that could not be treated preoperatively

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)
closed envelope technique
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
a total number of 152 envelopes were divided into 76 modified darn repair and 76 Lichtenstein Procedure. Envelopes are completely sealed and shuffled. An investigator with no clinical involvement in the trial and is blinded to the procedure chooses one envelope just before the surgery and inform the surgeon with the procedure to be done.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Randomization was done immediately before performing the precedue. so the surgeon knows the procedure just before the operation
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
12/02/2008
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
152
Accrual to date
Final
Recruitment outside Australia
Country [1] 4416 0
Egypt
State/province [1] 4416 0

Funding & Sponsors
Funding source category [1] 285677 0
Hospital
Name [1] 285677 0
Alexandria Main University Hospital
Country [1] 285677 0
Egypt
Primary sponsor type
Hospital
Name
Alexandria Main University Hospital
Address
Kolleyet Al Teb st. Azareeta, Alexandria, Egypt. PO 21321
Country
Egypt
Secondary sponsor category [1] 284506 0
None
Name [1] 284506 0
Address [1] 284506 0
Country [1] 284506 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 287664 0
Ethical commitee of Alexandria Main University Hospital
Ethics committee address [1] 287664 0
Ethics committee country [1] 287664 0
Egypt
Date submitted for ethics approval [1] 287664 0
Approval date [1] 287664 0
Ethics approval number [1] 287664 0

Summary
Brief summary
Is MDR as a tension free repair with no mesh application comparable to the standard Lichtenstein procedure in treating primary inguinal hernia.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 34468 0
Address 34468 0
Country 34468 0
Phone 34468 0
Fax 34468 0
Email 34468 0
Contact person for public queries
Name 17715 0
dr. walid moamed Abd El maksoud
Address 17715 0
6 albert al awwal st.
smouha
alexandria
PO 21311
Country 17715 0
Egypt
Phone 17715 0
+966543834949
Fax 17715 0
Email 17715 0
[email protected]
Contact person for scientific queries
Name 8643 0
dr. walid moamed Abd El maksoud
Address 8643 0
6 albert al awwal st.
smouha
alexandria
PO 21311
Country 8643 0
Egypt
Phone 8643 0
+966543834949
Fax 8643 0
Email 8643 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
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