NCT01348477

Brief Summary

The investigators describe a new surgical technique for inguinal hernia open repair, which will be compared with the Lichtenstein technique. The investigators seek to find the difference between the two techniques in postoperative pain.

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
168

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 5, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

May 5, 2011

Status Verified

September 1, 2010

Enrollment Period

1.2 years

First QC Date

May 2, 2011

Last Update Submit

May 4, 2011

Conditions

Inguinal Hernia

Keywords

inguinalherniapaininguinodyniamesh

Outcome Measures

Primary Outcomes (3)

  • pain one month after surgery

    Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.

    one month

  • pain three months after surgery

    Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.

    three months

  • pain six months after surgery

    Pain will be measured by the Visual Analogue Scale, from zero to ten. Measurements will be made per month, three months and six months after surgery. With these data we will built two survival curves (one for each group)with the proportions of patients still have pain in every time frame. We will compare the two curves with logrank statistic test.

    six months

Secondary Outcomes (3)

  • dysesthesia one month after surgery

    one month

  • dysesthesia three months after surgery

    three months

  • dysesthesia six months after surgery

    six months

Study Arms (2)

Elliptical domed mesh technique

EXPERIMENTAL

84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique

Procedure: Elliptical domed mesh technique

Lichtenstein technique

ACTIVE COMPARATOR

84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)

Procedure: Elliptical domed mesh technique

Interventions

Elliptical domed mesh techniquePROCEDURE

A segment of polypropylene mesh of 10 by 15cm enters the inguinal preperitoneal space, where takes the form of a dome and is fixed by four stitches

Also known as: preperitoneal mesh
Elliptical domed mesh techniqueLichtenstein technique

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult patients diagnosed with uncomplicated primary inguinal hernia
  • mentally healthy patients
  • patients without preoperative groin pain
  • patients eligible for outpatient surgery

You may not qualify if:

  • patients with different surgical diagnosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ambulatory care medical unit number 55 (UMAA 55)

León, Guanajuato, Mexico

RECRUITING

MeSH Terms

Conditions

Hernia, InguinalHerniaPain

Condition Hierarchy (Ancestors)

Hernia, AbdominalPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Rafal L Smolinski, surgeon

    IMSS

    PRINCIPAL INVESTIGATOR

  • Martha A Hernandez, researcher

    IMSS

    STUDY DIRECTOR

  • Sergio E Solorio, researcher

    IMSS

    STUDY CHAIR

Central Study Contacts

Rafal L Smolinski, surgeon

CONTACT

52-477-7768584ludwiksrk@hotmail.com

Sergio E Solorio, researcher

CONTACT

52-477-7174800soloriosergio@aol.com

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 GOV

Study Record Dates

First Submitted

May 2, 2011

First Posted

May 5, 2011

Study Start

October 1, 2010

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

May 5, 2011

Record last verified: 2010-09

Locations

ME(1)