Hernia Repair Four Arm Comparative Study

January 14, 2010 updated by: University of Alexandria

Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt, 261112
        • Main University hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • adult male primary inguinal hernia

Exclusion Criteria:

  • recurrent hernia previous lower abdominal surgery [excluding appendectomy]

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: open properitoneal
patients undergoing open properitoneal hernia repair
Procedure: open properitoneal hernia repair
suprapubic retro-inguinal approach
Other Names:
  • extraperitoneal repair
Active Comparator: Lechtenstien repair
Patients undergoing Lechtestien hernia repair
Procedure: Lechtestien hernia repair
onlay mesh repair
Other Names:
  • tension free repair
Active Comparator: Laparoscopic transperitoneal repair
Patients undergoing TAPP repair
Procedure: Laparoscopic transperitoneal approach
intraperitoneal insufflation followed by re-exiting to the hernia site
Other Names:
  • TAPP
Active Comparator: Lap totally extraperitoneal approach
Patients undergoing TEP approach
Procedure: Laparoscopic totally extraperitoneal approach
avoiding the peritoneum altogether
Other Names:
  • TEP

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
patient ability to resume domestic activity independently
Time Frame: daily reporting by the patient
daily reporting by the patient

Secondary Outcome Measures

Outcome Measure
Time Frame
time of the patient to return to work
Time Frame: reported by the patient
reported by the patient

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alexandria

Investigators

  • Principal Investigator: Yasser Hamza, A professor, University of Alexandria

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

July 15, 2009

First Submitted That Met QC Criteria

July 15, 2009

First Posted (Estimate)

July 16, 2009

Study Record Updates

Last Update Posted (Estimate)

January 15, 2010

Last Update Submitted That Met QC Criteria

January 14, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • # 90713

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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