Hernia Repair Four Arm Comparative Study

University of Alexandria

Status: Completed

Conditions: Inguinal Hernia

Treatments: Procedure: Laparoscopic transperitoneal approach; Procedure: Laparoscopic totally extraperitoneal approach; Procedure: open properitoneal hernia repair; Procedure: Lechtestien hernia repair

Study type: Interventional

Funder types: Other

Identifiers

NCT00940433

# 90713

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: Male

Volunteers: No Healthy Volunteers

Inclusion criteria

• adult male primary inguinal hernia

Exclusion criteria

• recurrent hernia previous lower abdominal surgery [excluding appendectomy]

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 4 patient groups

open properitoneal

Active Comparator group

Description:

patients undergoing open properitoneal hernia repair

Treatment:

Procedure: open properitoneal hernia repair

Lechtenstien repair

Active Comparator group

Description:

Patients undergoing Lechtestien hernia repair

Treatment:

Procedure: Lechtestien hernia repair

Laparoscopic transperitoneal repair

Active Comparator group

Description:

Patients undergoing TAPP repair

Treatment:

Procedure: Laparoscopic transperitoneal approach

Lap totally extraperitoneal approach

Active Comparator group

Description:

Patients undergoing TEP approach

Treatment:

Procedure: Laparoscopic totally extraperitoneal approach