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Completed

NCT Number: NCT00940433

Hernia Repair Four Arm Comparative Study

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.

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Key information

Conditions

Inguinal Hernia Hernia Hernia, Abdominal Hernia, Inguinal Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Main University hospital

Alexandria, Alexandria Governorate, 261112, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • adult male primary inguinal hernia

Exclusion criteria

  • recurrent hernia previous lower abdominal surgery [excluding appendectomy]

Treatment and study plan

open properitoneal hernia repair

Procedure

suprapubic retro-inguinal approach

Other names: extraperitoneal repair

Lechtestien hernia repair

Procedure

onlay mesh repair

Other names: tension free repair

Laparoscopic transperitoneal approach

Procedure

intraperitoneal insufflation followed by re-exiting to the hernia site

Other names: TAPP

Laparoscopic totally extraperitoneal approach

Procedure

avoiding the peritoneum altogether

Other names: TEP

Primary outcomes

  1. patient ability to resume domestic activity independently

    Time frame: daily reporting by the patient

Secondary outcomes

  1. time of the patient to return to work

    Time frame: reported by the patient

Sponsors and collaborators

Lead sponsor

University of Alexandria

Other

Registry information

Official study title

Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jul 16, 2009
Registry last updated
Jan 15, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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