Hernia Repair Four Arm Comparative Study
This study has been completed.
Sponsor:
Faculty of Medicine, University of Alexandria
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
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
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
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 May 23, 2013