Hernia Repair Four Arm Comparative Study

Inguinal Hernia Clinical Trial

Official title:

Four Arm Randomised Trial Comparing Laparoscopic And Open Hernia Repairs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00940433
• Other study ID #: # 90713
• Status: Completed
• Phase: N/A
• First received: July 15, 2009
• Last updated: January 14, 2010
• Start date: February 2008
• Est. completion date: December 2009

Study information

• Verified date: January 2010
• Source: Faculty of Medicine, University of Alexandria
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Health and Population
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• adult male primary inguinal hernia

Exclusion Criteria:

• recurrent hernia previous lower abdominal surgery [excluding appendectomy]

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

Procedure:
• open properitoneal hernia repair
suprapubic retro-inguinal approach
• Lechtestien hernia repair
onlay mesh repair
• Laparoscopic transperitoneal approach
intraperitoneal insufflation followed by re-exiting to the hernia site
• Laparoscopic totally extraperitoneal approach
avoiding the peritoneum altogether

Locations

Country	Name	City	State
Egypt	Main University hospital	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Medicine, University of Alexandria

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient ability to resume domestic activity independently		daily reporting by the patient	No
Secondary	time of the patient to return to work		reported by the patient	No