Back to resultsHernia Repair Four Arm Comparative Study
Primary Purpose
Inguinal Hernia
Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
open properitoneal hernia repair
Lechtestien hernia repair
Laparoscopic transperitoneal approach
Laparoscopic totally extraperitoneal approach
Sponsored by
About this trial
This is an interventional treatment trial for Inguinal Hernia focused on measuring Minimally invasive, Inguinal hernia, Pro-peritoneal repair
Eligibility Criteria
Inclusion Criteria:
- adult male primary inguinal hernia
Exclusion Criteria:
- recurrent hernia previous lower abdominal surgery [excluding appendectomy]
Sites / Locations
- Main University hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
open properitoneal
Lechtenstien repair
Laparoscopic transperitoneal repair
Lap totally extraperitoneal approach
Arm Description
patients undergoing open properitoneal hernia repair
Patients undergoing Lechtestien hernia repair
Patients undergoing TAPP repair
Patients undergoing TEP approach
Outcomes
Primary Outcome Measures
patient ability to resume domestic activity independently
Secondary Outcome Measures
time of the patient to return to work
Full Information
NCT ID
NCT00940433
First Posted
July 15, 2009
Last Updated
January 14, 2010
Sponsor
University of Alexandria
1. Study Identification
Unique Protocol Identification Number
NCT00940433
Brief Title
Hernia Repair Four Arm Comparative Study
Official Title
Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs
Study Type
Interventional
2. Study Status
Record Verification Date
January 2010
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Alexandria
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
Minimally invasive, Inguinal hernia, Pro-peritoneal repair
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
open properitoneal
Arm Type
Active Comparator
Arm Description
patients undergoing open properitoneal hernia repair
Arm Title
Lechtenstien repair
Arm Type
Active Comparator
Arm Description
Patients undergoing Lechtestien hernia repair
Arm Title
Laparoscopic transperitoneal repair
Arm Type
Active Comparator
Arm Description
Patients undergoing TAPP repair
Arm Title
Lap totally extraperitoneal approach
Arm Type
Active Comparator
Arm Description
Patients undergoing TEP approach
Intervention Type
Procedure
Intervention Name(s)
open properitoneal hernia repair
Other Intervention Name(s)
extraperitoneal repair
Intervention Description
suprapubic retro-inguinal approach
Intervention Type
Procedure
Intervention Name(s)
Lechtestien hernia repair
Other Intervention Name(s)
tension free repair
Intervention Description
onlay mesh repair
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic transperitoneal approach
Other Intervention Name(s)
TAPP
Intervention Description
intraperitoneal insufflation followed by re-exiting to the hernia site
Intervention Type
Procedure
Intervention Name(s)
Laparoscopic totally extraperitoneal approach
Other Intervention Name(s)
TEP
Intervention Description
avoiding the peritoneum altogether
Primary Outcome Measure Information:
Title
patient ability to resume domestic activity independently
Time Frame
daily reporting by the patient
Secondary Outcome Measure Information:
Title
time of the patient to return to work
Time Frame
reported by the patient
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
adult male primary inguinal hernia
Exclusion Criteria:
recurrent hernia previous lower abdominal surgery [excluding appendectomy]
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yasser Hamza, A professor
Organizational Affiliation
University of Alexandria
Official's Role
Principal Investigator
Facility Information:
Facility Name
Main University hospital
City
Alexandria
ZIP/Postal Code
261112
Country
Egypt
12. IPD Sharing Statement
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Hernia Repair Four Arm Comparative Study
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