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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2010 by Instituto Mexicano del Seguro Social.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Instituto Mexicano del Seguro Social
ClinicalTrials.gov Identifier:
NCT01348477
First received: May 2, 2011
Last updated: May 4, 2011
Last verified: September 2010
  Purpose

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.


Condition Intervention
Inguinal Hernia
Procedure: Elliptical domed mesh technique

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair

Resource links provided by NLM:


Further study details as provided by Instituto Mexicano del Seguro Social:

Primary Outcome Measures:
  • pain one month after surgery [ Time Frame: one month ] [ Designated as safety issue: No ]
    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 [ Time Frame: three months ] [ Designated as safety issue: No ]
    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 [ Time Frame: six months ] [ Designated as safety issue: No ]
    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 [ Time Frame: one month ] [ Designated as safety issue: No ]
    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 [ Time Frame: three months ] [ Designated as safety issue: No ]
    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 [ Time Frame: six months ] [ Designated as safety issue: No ]
    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.


Estimated Enrollment: 168
Study Start Date: October 2010
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elliptical domed mesh technique
84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique
Procedure: Elliptical domed mesh technique
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
Other Name: preperitoneal mesh
Active Comparator: Lichtenstein technique
84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)
Procedure: Elliptical domed mesh technique
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
Other Name: preperitoneal mesh

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01348477

Contacts
Contact: Rafal L Smolinski, surgeon 52-477-7768584 ludwiksrk@hotmail.com
Contact: Sergio E Solorio, researcher 52-477-7174800 soloriosergio@aol.com

Locations
Mexico
Ambulatory care medical unit number 55 (UMAA 55) Recruiting
Leon, Guanajuato, Mexico
Contact: Rafal L Smolinski, surgeon    52-477-7768584    ludwiksrk@hotmail.com   
Contact: Sergio E Solorio, researcher    52-477-7174800    soloriosergio@aol.com   
Principal Investigator: Martha A Hernandez, researcher         
Principal Investigator: Rafal L Smolinski, surgeon         
Principal Investigator: Sergio E Solorio, researcher         
Sub-Investigator: Juan C Mayagoitia, surgeon         
Sponsors and Collaborators
Instituto Mexicano del Seguro Social
Investigators
Principal Investigator: Rafal L Smolinski, surgeon IMSS
Study Director: Martha A Hernandez, researcher IMSS
Study Chair: Sergio E Solorio, researcher IMSS
  More Information

No publications provided

Responsible Party: Smolinski Kurek Rafal Ludwik, Mexican Social Security Institute
ClinicalTrials.gov Identifier: NCT01348477     History of Changes
Other Study ID Numbers: R-2010-1005-10
Study First Received: May 2, 2011
Last Updated: May 4, 2011
Health Authority: Mexico: Coordinación de Investigación en Salud

Keywords provided by Instituto Mexicano del Seguro Social:
inguinal
hernia
pain
inguinodynia
mesh

Additional relevant MeSH terms:
Hernia
Hernia, Inguinal
Hernia, Abdominal
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on October 22, 2014