NCT01090219

Brief Summary

The aim of this study was to analyze the shrinkage of two different screens in the repair of inguinal hernias in men . 32 patients with unilateral inguinal hernia were assigned randomly. A Lichtenstein tension-free hernia repair was accomplished by emplacing heavy weight versus ultralight weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2008

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 18, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 19, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
Last Updated

March 19, 2010

Status Verified

February 1, 2008

Enrollment Period

2 years

First QC Date

March 18, 2010

Last Update Submit

March 18, 2010

Conditions

Inguinal Hernias

Keywords

Inguinal Herniacontraction of two different meshes in the repair of inguinal hernias in men

Outcome Measures

Primary Outcomes (1)

  • contraction of two different meshes in the repair of inguinal hernias in men

    digital radiography in post-surgical days: 1, 30, 60 and 90

Study Arms (1)

two differents meshes

EXPERIMENTAL

Heavy-weight versus low-weight polypropylene meshes

Procedure: two different meshes in the repair of inguinal hernias

Interventions

two different meshes in the repair of inguinal herniasPROCEDURE

A Lichtenstein tension-free hernia repair was accomplished by emplacing Heavy-weight versus low-weight polypropylene meshes for repair of incisional hernia, marked next to the lips with six titanium clips (LT200)

two differents meshes

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Elective Surgery
  • Men with unilateral inguinal hernia
  • Age 20 - 50 years

You may not qualify if:

  • BMI\> 30
  • Recurrent inguinal hernia
  • Strangulated inguinal hernia
  • Anesthetic risk ASA III and IV
  • Diabetics
  • COPD
  • Benign prostatic hypertrophy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

São José Hospital

Criciúma, Santa Catarina, Brazil

RECRUITING

Universidade do Extremo Sul Catarinense

Criciúma, Santa Catarina, Brazil

RECRUITING

MeSH Terms

Conditions

Hernia, Inguinal

Condition Hierarchy (Ancestors)

Hernia, AbdominalHerniaPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Central Study Contacts

Maria I Rosa, Ph.D.

CONTACT

+5548 34339976mir@unesc.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 18, 2010

First Posted

March 19, 2010

Study Start

February 1, 2008

Primary Completion

February 1, 2010

Study Completion

July 1, 2010

Last Updated

March 19, 2010

Record last verified: 2008-02

Locations

BR(2)