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
  Purpose

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.


Condition Intervention
Inguinal Hernia
Procedure: open properitoneal hernia repair
Procedure: Lechtestien hernia repair
Procedure: Laparoscopic transperitoneal approach
Procedure: Laparoscopic totally extraperitoneal approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs

Resource links provided by NLM:


Further study details as provided by Faculty of Medicine, University of Alexandria:

Primary Outcome Measures:
  • patient ability to resume domestic activity independently [ Time Frame: daily reporting by the patient ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • time of the patient to return to work [ Time Frame: reported by the patient ] [ Designated as safety issue: No ]

Enrollment: 100
Study Start Date: February 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: open properitoneal
patients undergoing open properitoneal hernia repair
Procedure: open properitoneal hernia repair
suprapubic retro-inguinal approach
Other Name: extraperitoneal repair
Active Comparator: Lechtenstien repair
Patients undergoing Lechtestien hernia repair
Procedure: Lechtestien hernia repair
onlay mesh repair
Other Name: 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 Name: TAPP
Active Comparator: Lap totally extraperitoneal approach
Patients undergoing TEP approach
Procedure: Laparoscopic totally extraperitoneal approach
avoiding the peritoneum altogether
Other Name: TEP

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.

  Eligibility

Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult male primary inguinal hernia

Exclusion Criteria:

  • recurrent hernia previous lower abdominal surgery [excluding appendectomy]
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00940433

Locations
Egypt
Main University hospital
Alexandria, Egypt, 261112
Sponsors and Collaborators
Faculty of Medicine, University of Alexandria
Investigators
Principal Investigator: Yasser Hamza, A professor Faculty of Medicine, University of Alexandria
  More Information

No publications provided

Responsible Party: Yasser Hamza, Faculty of Medicine, University of Alexandria
ClinicalTrials.gov Identifier: NCT00940433     History of Changes
Other Study ID Numbers: # 90713
Study First Received: July 15, 2009
Last Updated: January 14, 2010
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Faculty of Medicine, University of Alexandria:
Minimally invasive
Inguinal hernia
Pro-peritoneal repair

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on September 22, 2014