Hernia Repair Four Arm Comparative Study

NCT ID: NCT00940433

Last Updated: 2010-01-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-12-31

Brief Summary

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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

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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.

Conditions

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Inguinal Hernia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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open properitoneal

patients undergoing open properitoneal hernia repair

Group Type ACTIVE_COMPARATOR

open properitoneal hernia repair

Intervention Type PROCEDURE

suprapubic retro-inguinal approach

Lechtenstien repair

Patients undergoing Lechtestien hernia repair

Group Type ACTIVE_COMPARATOR

Lechtestien hernia repair

Intervention Type PROCEDURE

onlay mesh repair

Laparoscopic transperitoneal repair

Patients undergoing TAPP repair

Group Type ACTIVE_COMPARATOR

Laparoscopic transperitoneal approach

Intervention Type PROCEDURE

intraperitoneal insufflation followed by re-exiting to the hernia site

Lap totally extraperitoneal approach

Patients undergoing TEP approach

Group Type ACTIVE_COMPARATOR

Laparoscopic totally extraperitoneal approach

Intervention Type PROCEDURE

avoiding the peritoneum altogether

Interventions

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open properitoneal hernia repair

suprapubic retro-inguinal approach

Intervention Type PROCEDURE

Lechtestien hernia repair

onlay mesh repair

Intervention Type PROCEDURE

Laparoscopic transperitoneal approach

intraperitoneal insufflation followed by re-exiting to the hernia site

Intervention Type PROCEDURE

Laparoscopic totally extraperitoneal approach

avoiding the peritoneum altogether

Intervention Type PROCEDURE

Other Intervention Names

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extraperitoneal repair tension free repair TAPP TEP

Eligibility Criteria

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Inclusion Criteria

* adult male primary inguinal hernia

Exclusion Criteria

* recurrent hernia previous lower abdominal surgery \[excluding appendectomy\]
Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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University of Alexandria

OTHER

Sponsor Role lead

Responsible Party

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Faculty of Medicine, University of Alexandria

Principal Investigators

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Yasser Hamza, A professor

Role: PRINCIPAL_INVESTIGATOR

University of Alexandria

Locations

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Main University hospital

Alexandria, Alexandria Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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# 90713

Identifier Type: -

Identifier Source: org_study_id

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