Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614001047684
Ethics application status
Approved
Date submitted
23/09/2014
Date registered
30/09/2014
Date last updated
3/12/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Comparative study between chronic post operative pain after using polypropylene mesh and self fixating mesh for management of primary inguinal hernia in adult males: a prospective randomized controlled trial
Scientific title
Comparative study between Lichtenstein procedure using polypropylene mesh and self fixating mesh for management of primary inguinal hernia in adult males in terms of chronic post operative pain: a prospective randomized controlled trial
Secondary ID [1] 285385 0
nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Inguinal Hernia 293123 0
Chronic post operative pain 293124 0
Condition category
Condition code
Surgery 293393 293393 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lichtenstein procedure; semi-absorbable self fixating mesh
“ParietexProgrip Trademark Mesh” (12X8 cm) is applied over the fascia transversalis after herniotomy and narrowing of the deep ring. For application of the mesh, anatomy around the spermatic
cord should be clear. The flap of the mesh is opened and closed loosely around the spermatic cord. The mesh was presented with the self gripping surface facing the tissues. Mesh is applied from medial side exceeding one centimeter
of the pubic bone first then was spread on the surrounding tissue around the spermatic cord starting by spreading the cranial part and lastly fixing the lower part to inguinal ligament. No sutures were used for fixation of the mesh.
Care was taken to avoid folding the mesh. Trimming
small part of the mesh may be needed to achieve the non folding. We completed the procedure by closing the external spermatic fascia and the skin. Procedure duration is about (60 - 120 minutes)
Intervention code [1] 290303 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] 293224 0
chronic post operative pain
Timepoint [1] 293224 0
base line, then at 3,6, and 12 months post operatively, measured by Visual Analogue Scale
Secondary outcome [1] 310625 0
recurrence
Timepoint [1] 310625 0
at 3,6, and 12 months post operatively, measured by clinical examination
Secondary outcome [2] 310626 0
operative time
Timepoint [2] 310626 0
intraoperative measured by time (minutes)
Secondary outcome [3] 310627 0
time to return to domestic and work activity
Timepoint [3] 310627 0
at 14 days and 30 days 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
No limit
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 90 envelopes were divided into 45 polypropylene mesh and 45 self fixating mesh. Envelopes are completely sealed and shuffled. An operating nurse with no clinical involvement in the trial and is blinded to the procedure chooses one envelope just before the surgery and informs the surgeon with the procedure to be done.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Type of endpoint/s
Efficacy
Statistical methods / analysis
Minimal sample size needed for each group was calculated
to be 37. The calculation was based on a of
0.05, power of 0.80. (with effect size 0.2 =19%).
It was calculated by using G power program version
3.1.3 2007

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
18/10/2014
Actual
26/10/2014
Date of last participant enrolment
Anticipated
1/12/2015
Actual
4/11/2015
Date of last data collection
Anticipated
Actual
Sample size
Target
74
Accrual to date
Final
90
Recruitment outside Australia
Country [1] 6373 0
Saudi Arabia
State/province [1] 6373 0
Asir

Funding & Sponsors
Funding source category [1] 289995 0
Self funded/Unfunded
Name [1] 289995 0
Country [1] 289995 0
Primary sponsor type
University
Name
King Khalid University
Address
Greiger
PO: 641
Zip: 61421
Abha
Country
Saudi Arabia
Secondary sponsor category [1] 288680 0
Hospital
Name [1] 288680 0
Aseer Central Hospital
Address [1] 288680 0
King Abdullah Road
PO Box 34
Zip: 62523
Abha
Saudi Arabia
Country [1] 288680 0
Saudi Arabia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293967 0
Research ethical committee of King Khalid University
Ethics committee address [1] 293967 0
Ethics committee country [1] 293967 0
Saudi Arabia
Date submitted for ethics approval [1] 293967 0
26/01/2015
Approval date [1] 293967 0
05/03/2015
Ethics approval number [1] 293967 0
HA-06-B-001

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 659 659 0 0
/AnzctrAttachments/367143-Ethical approval.docx

Contacts
Principal investigator
Name 51630 0
A/Prof Walid Abd El Maksoud MD, MRCS
Address 51630 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 51630 0
Saudi Arabia
Phone 51630 0
+966543128555
Fax 51630 0
Email 51630 0
[email protected]
Contact person for public queries
Name 51631 0
Walid Abd El Maksoud MD, MRCS
Address 51631 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 51631 0
Saudi Arabia
Phone 51631 0
+966543128555
Fax 51631 0
Email 51631 0
[email protected]
Contact person for scientific queries
Name 51632 0
Walid Abd El Maksoud MD, MRCS
Address 51632 0
King Khalid University, Abha, Saudi Arabia Faculty of Medicine Department of General Surgery Zip: 61421 P.O.: 641
Country 51632 0
Saudi Arabia
Phone 51632 0
+966543128555
Fax 51632 0
Email 51632 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.