Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613001050741
Ethics application status
Approved
Date submitted
17/09/2013
Date registered
20/09/2013
Date last updated
20/09/2013
Type of registration
Retrospectively registered

Titles & IDs
Public title
Laparoscopic Transabdominal Preperitoneal For Recurrent Inguinal Hernia: A Randomized Trial
Scientific title
Identifying the recurrence rate, time off from work, postoperative pain, scrotal swelling and wound infections in laparoscopic transabdominal preperitoneal , open preperitoneal versus anterior approach for recurrent inguinal hernia: a prospective randomized trial
Secondary ID [1] 283241 0
none
Universal Trial Number (UTN)
U1111-1148-1455
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Recurrent inguinal hernia 290109 0
Inguinoscrotal swellings 290123 0
Condition category
Condition code
Surgery 290489 290489 0 0
Surgical techniques

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
1-The laparoscopic transabdominal preperitoneal repair (TAPP):
The hernia defect was inspected. The properitoneal space was dissected from lateral to medial at the level of the retroinguinal (Bogros') space, with parietalization of the spermatic cord posteriorly and outwards. The dissection was continued medially towards the retropubic space, extending behind the symphysis pubis and iliopubic tract, exposing the pectineal ligament. The peritoneum forming the hernia sac was pulled in, separating it from the cord structures. A 15 x 10 cm sheet of polypropylene mesh was placed so as to cover the Hesselbach's triangle, the indirect space, and the femoral ring areas. The mesh was fixed using an endoscopic multifire hernia stapler. The mean operative time was 122.5 minutes (80-170).
2- 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 (40–120).
Intervention code [1] 287966 0
Treatment: Surgery
Comparator / control treatment
Intervention: Laparoscopic Transabdominal Preperitoneal and 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 was 94.7 minutes (60-150).
Control group
Active

Outcomes
Primary outcome [1] 290512 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 authors.
Timepoint [1] 290512 0
The follow up period was 41 +/- 26.87 months
Secondary outcome [1] 304680 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] 304680 0
from the day of surgery until the first day a patient returned to work
Secondary outcome [2] 304681 0
Postoperative pain was assessed using Visual Analog Scale pain score (1–10): Mild (1–4) , moderate (5–7), severe (8–10).
Timepoint [2] 304681 0
Postoperative pain was assessed after one month post-operatively.
Secondary outcome [3] 304682 0
Scrotal swelling was assessed clinically by the treating surgeons.
Timepoint [3] 304682 0
2 weeks
Secondary outcome [4] 304683 0
Wound infection was assessed clinically by the treating surgeons.
Timepoint [4] 304683 0
2 weeks

Eligibility
Key inclusion criteria
all patients are of male sex and had 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
6/01/2007
Date of last participant enrolment
Anticipated
Actual
23/04/2011
Date of last data collection
Anticipated
Actual
Sample size
Target
60
Accrual to date
Final
Recruitment outside Australia
Country [1] 5417 0
Egypt
State/province [1] 5417 0

Funding & Sponsors
Funding source category [1] 287981 0
Hospital
Name [1] 287981 0
Port-Fouad general hospital
Country [1] 287981 0
Egypt
Funding source category [2] 287982 0
Hospital
Name [2] 287982 0
Suez Canal University hospital
Country [2] 287982 0
Egypt
Primary sponsor type
Individual
Name
Aly Saber
Address
19 Al-guish street, postal code:11433 Port-Fouad ,Port-Said , Egypt
Country
Egypt
Secondary sponsor category [1] 286702 0
None
Name [1] 286702 0
Address [1] 286702 0
Country [1] 286702 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289911 0
Ethical committee of Port- Fouad general hospital
Ethics committee address [1] 289911 0
Ethics committee country [1] 289911 0
Egypt
Date submitted for ethics approval [1] 289911 0
Approval date [1] 289911 0
Ethics approval number [1] 289911 0

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

Contacts
Principal investigator
Name 43034 0
Dr Aly Saber
Address 43034 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 43034 0
Egypt
Phone 43034 0
+201223752032
Fax 43034 0
Email 43034 0
[email protected]
Contact person for public queries
Name 43035 0
Aly Saber
Address 43035 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 43035 0
Egypt
Phone 43035 0
+201223752032
Fax 43035 0
Email 43035 0
[email protected]
Contact person for scientific queries
Name 43036 0
Aly Saber
Address 43036 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 43036 0
Egypt
Phone 43036 0
+201223752032
Fax 43036 0
Email 43036 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.