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Hernia Repair Four Arm Comparative Study

Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00940433
Enrollment
100
Registered
2009-07-16
Start date
2008-02-29
Completion date
2009-12-31
Last updated
2010-01-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inguinal Hernia

Keywords

Minimally invasive, Inguinal hernia, Pro-peritoneal repair

Brief summary

This study compares the outcome of the four most commonly used operations for the repair of primary groin hernia including the new key hole surgical techniques. It aims at answering the question of whether the new technology really improve the outcome, saves time and reduce patient suffering.

Detailed description

The study compares two traditional techniques of inguinal hernia repair; namely Lechtenstien repair and properitoneal repair versus two techniques of laparoscopic hernia repair, namely extraperitoneal and transperitoneal repair. It compares the operative time, complications, postoperative pain and the speed of patient recovery.

Interventions

PROCEDUREopen properitoneal hernia repair

suprapubic retro-inguinal approach

PROCEDURELechtestien hernia repair

onlay mesh repair

PROCEDURELaparoscopic transperitoneal approach

intraperitoneal insufflation followed by re-exiting to the hernia site

PROCEDURELaparoscopic totally extraperitoneal approach

avoiding the peritoneum altogether

Sponsors

University of Alexandria
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Healthy volunteers
No

Inclusion criteria

* adult male primary inguinal hernia

Exclusion criteria

* recurrent hernia previous lower abdominal surgery \[excluding appendectomy\]

Design outcomes

Primary

MeasureTime frame
patient ability to resume domestic activity independentlydaily reporting by the patient

Secondary

MeasureTime frame
time of the patient to return to workreported by the patient

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026