Hernia Repair Four Arm Comparative Study | NCT00940433

Studies
Hernia Repair Four Arm Comparative Study

NCT00940433

Sponsor

University of Alexandria

Status

Completed

Last Update Posted

Jan 15, 2010Estimated

Enrollment

100Actual

Phase

Not Applicable

Conditions

Inguinal Hernia

Interventions

open properitoneal hernia repair
Lechtestien hernia repair
Laparoscopic transperitoneal approach
Laparoscopic totally extraperitoneal approach

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2008

Primary Completion Date

Dec 2009Actual

Completion Date

Dec 2009Actual

First Submitted Date

Jul 15, 2009

First Submission Date that Met QC Criteria

Jul 15, 2009

First Posted Date

Jul 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 14, 2010

Last Update Posted Date

Jan 15, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
open properitoneal	Active Comparator	patients undergoing open properitoneal hernia repair	Procedure: open properitoneal hernia repair
Lechtenstien repair	Active Comparator	Patients undergoing Lechtestien hernia repair	Procedure: Lechtestien hernia repair
Laparoscopic transperitoneal repair	Active Comparator	Patients undergoing TAPP repair	Procedure: Laparoscopic transperitoneal approach
Lap totally extraperitoneal approach	Active Comparator	Patients undergoing TEP approach	Procedure: Laparoscopic totally extraperitoneal approach

Interventions

Name	Type	Description	Arm Group Labels	Other Names
open properitoneal hernia repair	Procedure	suprapubic retro-inguinal approach	open properitoneal

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
patient ability to resume domestic activity independently		daily reporting by the patient

Secondary Outcomes

Measure	Description	Time Frame
time of the patient to return to work		reported by the patient

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adult male primary inguinal hernia

Exclusion Criteria:

recurrent hernia previous lower abdominal surgery [excluding appendectomy]

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yasser Hamza, A professor	University of Alexandria	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Main University hospital		Alexandria	Alexandria Governorate	261112	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006552	Hernia, Inguinal

Ancestor Terms

ID	Term
D046449	Hernia, Abdominal
D006547	Hernia
D020763	Pathological Conditions, Anatomical
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C034807	tetra-4-amidinophenoxypropane
C072829	tetraethylpyrazine

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided