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Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia

Primary Purpose

Inguinal Hernia

Status
Unknown status
Phase
Not Applicable
Locations
Mexico
Study Type
Interventional
Intervention
Elliptical domed mesh technique
Sponsored by
Instituto Mexicano del Seguro Social
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia focused on measuring inguinal, hernia, pain, inguinodynia, mesh

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • patients with different surgical diagnosis

Sites / Locations

  • Ambulatory care medical unit number 55 (UMAA 55)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Elliptical domed mesh technique

Lichtenstein technique

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

dysesthesia one month after surgery
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
dysesthesia three months after surgery
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
dysesthesia six months after surgery
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.

Full Information

First Posted
May 2, 2011
Last Updated
May 4, 2011
Sponsor
Instituto Mexicano del Seguro Social
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1. Study Identification

Unique Protocol Identification Number
NCT01348477
Brief Title
Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia
Official Title
Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair
Study Type
Interventional

2. Study Status

Record Verification Date
September 2010
Overall Recruitment Status
Unknown status
Study Start Date
October 2010 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
December 2011 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Instituto Mexicano del Seguro Social

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
The investigators randomly assigned 168 adult patients with uncomplicated primary inguinal hernia to two treatment groups: Group A: 84 patients treated with the new technique Group B: 84 patients treated with the technique of Lichtenstein (gold standard) The investigators reviewed the patients operated on one week, one month, three months and six months after surgery. The investigators evaluated the presence of moderate to severe pain in each technique, as well as the intensity of pain, measured by visual analogue scale. The investigators also determined the presence of inguinal dysesthesias in each technique, measured by dermatome mapping.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia
Keywords
inguinal, hernia, pain, inguinodynia, mesh

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
168 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Elliptical domed mesh technique
Arm Type
Experimental
Arm Description
84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique
Arm Title
Lichtenstein technique
Arm Type
Active Comparator
Arm Description
84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)
Intervention Type
Procedure
Intervention Name(s)
Elliptical domed mesh technique
Other Intervention Name(s)
preperitoneal mesh
Intervention Description
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
Primary Outcome Measure Information:
Title
pain one month after surgery
Description
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.
Time Frame
one month
Title
pain three months after surgery
Description
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.
Time Frame
three months
Title
pain six months after surgery
Description
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.
Time Frame
six months
Secondary Outcome Measure Information:
Title
dysesthesia one month after surgery
Description
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
Time Frame
one month
Title
dysesthesia three months after surgery
Description
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
Time Frame
three months
Title
dysesthesia six months after surgery
Description
Inguinal dysesthesia will be measured by inguinal dermatome mapping, looking for anesthesia, hypoesthesia and hyperesthesia. Dysesthesias will be measured at one month, three months and six months. We dont know if there will be changes in dysesthesias over time but it is possible.
Time Frame
six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adult patients diagnosed with uncomplicated primary inguinal hernia mentally healthy patients patients without preoperative groin pain patients eligible for outpatient surgery Exclusion Criteria: patients with different surgical diagnosis
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rafal L Smolinski, surgeon
Phone
52-477-7768584
Email
ludwiksrk@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Sergio E Solorio, researcher
Phone
52-477-7174800
Email
soloriosergio@aol.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rafal L Smolinski, surgeon
Organizational Affiliation
IMSS
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martha A Hernandez, researcher
Organizational Affiliation
IMSS
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sergio E Solorio, researcher
Organizational Affiliation
IMSS
Official's Role
Study Chair
Facility Information:
Facility Name
Ambulatory care medical unit number 55 (UMAA 55)
City
Leon
State/Province
Guanajuato
Country
Mexico
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rafal L Smolinski, surgeon
Phone
52-477-7768584
Email
ludwiksrk@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sergio E Solorio, researcher
Phone
52-477-7174800
Email
soloriosergio@aol.com
First Name & Middle Initial & Last Name & Degree
Martha A Hernandez, researcher
First Name & Middle Initial & Last Name & Degree
Rafal L Smolinski, surgeon
First Name & Middle Initial & Last Name & Degree
Sergio E Solorio, researcher
First Name & Middle Initial & Last Name & Degree
Juan C Mayagoitia, surgeon

12. IPD Sharing Statement

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Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia

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