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Hernia Repair Four Arm Comparative Study

This study has been completed.
Sponsor:
Information provided by:
Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier:
NCT00940433
First received: July 15, 2009
Last updated: January 14, 2010
Last verified: January 2010

July 15, 2009
January 14, 2010
February 2008
December 2009   (final data collection date for primary outcome measure)
patient ability to resume domestic activity independently [ Time Frame: daily reporting by the patient ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00940433 on ClinicalTrials.gov Archive Site
time of the patient to return to work [ Time Frame: reported by the patient ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Hernia Repair Four Arm Comparative Study
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Inguinal Hernia
  • Procedure: open properitoneal hernia repair
    suprapubic retro-inguinal approach
    Other Name: extraperitoneal repair
  • Procedure: Lechtestien hernia repair
    onlay mesh repair
    Other Name: tension free repair
  • Procedure: Laparoscopic transperitoneal approach
    intraperitoneal insufflation followed by re-exiting to the hernia site
    Other Name: TAPP
  • Procedure: Laparoscopic totally extraperitoneal approach
    avoiding the peritoneum altogether
    Other Name: TEP
  • Active Comparator: open properitoneal
    patients undergoing open properitoneal hernia repair
    Intervention: Procedure: open properitoneal hernia repair
  • Active Comparator: Lechtenstien repair
    Patients undergoing Lechtestien hernia repair
    Intervention: Procedure: Lechtestien hernia repair
  • Active Comparator: Laparoscopic transperitoneal repair
    Patients undergoing TAPP repair
    Intervention: Procedure: Laparoscopic transperitoneal approach
  • Active Comparator: Lap totally extraperitoneal approach
    Patients undergoing TEP approach
    Intervention: Procedure: Laparoscopic totally extraperitoneal approach
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
100
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • adult male primary inguinal hernia

Exclusion Criteria:

  • recurrent hernia previous lower abdominal surgery [excluding appendectomy]
Male
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Egypt
 
NCT00940433
# 90713
No
Yasser Hamza, Faculty of Medicine, University of Alexandria
Faculty of Medicine, University of Alexandria
Not Provided
Principal Investigator: Yasser Hamza, A professor Faculty of Medicine, University of Alexandria
Faculty of Medicine, University of Alexandria
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP