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Trial registered on ANZCTR

Registration number
Ethics application status
Date submitted
Date registered
Date last updated
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
Universal Trial Number (UTN)
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

Study type
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

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

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
Can healthy volunteers participate?
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
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
Other design features
Not Applicable
Type of endpoint(s)
Statistical methods / analysis

Recruitment status
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment outside Australia
Country [1] 5417 0
State/province [1] 5417 0

Funding & Sponsors
Funding source category [1] 287981 0
Name [1] 287981 0
Port-Fouad general hospital
Address [1] 287981 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country [1] 287981 0
Funding source category [2] 287982 0
Name [2] 287982 0
Suez Canal University hospital
Address [2] 287982 0
Faculty of medicine, Suez Canal University. Sheikh Zaid zone, postal code: 22366, Ismailia, Egypt
Country [2] 287982 0
Primary sponsor type
Aly Saber
19 Al-guish street, postal code:11433 Port-Fouad ,Port-Said , Egypt
Secondary sponsor category [1] 286702 0
Name [1] 286702 0
Address [1] 286702 0
Country [1] 286702 0

Ethics approval
Ethics application status
Ethics committee name [1] 289911 0
Ethical committee of Port- Fouad general hospital
Ethics committee address [1] 289911 0
Al-obour zone, postal code :11644 , Port- Fouad general hospital, Port-Fouad, Port-Said, Egypt.
Ethics committee country [1] 289911 0
Date submitted for ethics approval [1] 289911 0
Approval date [1] 289911 0
Ethics approval number [1] 289911 0

Brief summary
The present work aimed at comparing three approaches in repair of recurrent inguinal hernia: anterior inguinal approach, open properitoneal repair and transabdominal pro-peritoneal repair and as regards regarding complications and early recurrence.
Trial website
Trial related presentations / publications
Public notes

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
Phone 43034 0
Fax 43034 0
Email 43034 0
Contact person for public queries
Name 43035 0
Dr Aly Saber
Address 43035 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 43035 0
Phone 43035 0
Fax 43035 0
Email 43035 0
Contact person for scientific queries
Name 43036 0
Dr Aly Saber
Address 43036 0
Al-obour zone, postal code: 11664,Port-Fouad general hospital, Port-Fouad, Port-Said, Egypt
Country 43036 0
Phone 43036 0
Fax 43036 0
Email 43036 0

No data has been provided for results reporting
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary