Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000337976
Ethics application status
Approved
Date submitted
24/03/2011
Date registered
31/03/2011
Date last updated
31/03/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Open preperitoneal versus anterior approach
for recurrent inguinal hernia
Scientific title
Identifying the recurrence rate, time off from work, postoperative pain, scrotal swelling and wound infections in open preperitoneal versus anterior approach for recurrent inguinal hernia: a prospective randomized trial
Secondary ID [1] 259849 0
no
Universal Trial Number (UTN)
U1111-1120-2671
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
recurrent inguinal hernia 265425 0
Condition category
Condition code
Surgery 265584 265584 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The open preperitoneal approach to the inguinal region was performed under general or regional anesthesia, as originally described by Nyhus . Through a lower abdominal transverse incision, the anterior rectus sheath was incised and the rectus muscle reflected medially. The preperitoneal space was cleaved with blunt dissection, exposing the myopectineal orifice. The cord was explored and the hernias were reduced. A 15x15 cm polypropylene mesh with a slit was inserted in the preperitoneal space and fixed with nonabsorbable sutures to pubic tubercle and Cooper's ligament. The mesh was passed behind the cord and manipulated to lay flat against the posterior inguinal floor overlapping the entire myopectineal orifice. The mean operative time was 71.6 minutes .
Intervention code [1] 264267 0
Treatment: Surgery
Comparator / control treatment
Intervention: Open preperitoneal approach Comparator/Control: anterior inguinal approach.
The anterior tension-free repair, as defined by Lichtenstein was performed using 6 x 11 cm polypropylene mesh. The mean operative time in group A was 71.6 minutes . In group B , the mean value was 94.7 minutes .
The time of hospital stay and the time off from work were less in posterior preperitoneal repair groups.
Chronic postoperative pain,scrotal swelling and testicular atrophy were less in preperitoneal approach
Control group
Active

Outcomes
Primary outcome [1] 262381 0
The primary end point of the study was recurrence of the hernia, defined as a clinically detectable characteristic swelling in the groin and diagnosed by the two authors.
Timepoint [1] 262381 0
The main follow up period was 37.11 months.
Secondary outcome [1] 273667 0
The secondary end points were time off from work, defined as the number of days between the day of surgery and the first day a patient returned to work .
Timepoint [1] 273667 0
1.5 months
Secondary outcome [2] 273685 0
postoperative pain
Timepoint [2] 273685 0
4 months
Secondary outcome [3] 273686 0
scrotal swelling
Timepoint [3] 273686 0
2 weeks
Secondary outcome [4] 273687 0
wound infections
Timepoint [4] 273687 0
2 weeks

Eligibility
Key inclusion criteria
all patients having unilateral recurrent inguinal scrotal and irreducible hernias.
Minimum age
42 Years
Maximum age
65 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Patients with primary inguinal hernias and patients with marked obesity (BMI > 35) and ASA grade 3 and beyond were excluded

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not 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
Completed
Date of first participant enrolment
Anticipated
1/01/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
50
Accrual to date
Final
Recruitment outside Australia
Country [1] 3314 0
Egypt
State/province [1] 3314 0

Funding & Sponsors
Funding source category [1] 264734 0
Hospital
Name [1] 264734 0
Port-Fouad general hospital
Country [1] 264734 0
Egypt
Funding source category [2] 264735 0
Hospital
Name [2] 264735 0
Suez Canal University hospital
Country [2] 264735 0
Egypt
Primary sponsor type
Individual
Name
Aly Saber
Address
Port-Fouad General Hospital, Department of general surgery,
Port-Fouad, Port-Said, Egypt.
Country
Egypt
Secondary sponsor category [1] 263850 0
None
Name [1] 263850 0
Address [1] 263850 0
Country [1] 263850 0

Ethics approval
Ethics application status
Approved

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

Contacts
Principal investigator
Name 32379 0
Address 32379 0
Country 32379 0
Phone 32379 0
Fax 32379 0
Email 32379 0
Contact person for public queries
Name 15626 0
Aly Saber
Address 15626 0
Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 15626 0
Egypt
Phone 15626 0
+2/066/ 3406474
Fax 15626 0
Email 15626 0
[email protected]
Contact person for scientific queries
Name 6554 0
Aly Saber
Address 6554 0
Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 6554 0
Egypt
Phone 6554 0
+2/066/3406474
Fax 6554 0
Email 6554 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.