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

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ClinicalTrials.gov Identifier: NCT01348477
Recruitment Status : Unknown
Verified September 2010 by Instituto Mexicano del Seguro Social.
Recruitment status was:  Recruiting
First Posted : May 5, 2011
Last Update Posted : May 5, 2011
Sponsor:
Information provided by:

May 2, 2011
May 5, 2011
May 5, 2011
October 2010
December 2011   (Final data collection date for primary outcome measure)
  • pain one month after surgery [ Time Frame: one month ]
    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 ]
    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 ]
    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.
Same as current
No Changes Posted
  • dysesthesia one month after surgery [ Time Frame: one month ]
    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 ]
    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 ]
    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.
Same as current
Not Provided
Not Provided
 
Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique in Inguinal Hernia
Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair
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.

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.

Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Inguinal Hernia
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
  • Experimental: Elliptical domed mesh technique
    84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique
    Intervention: Procedure: Elliptical domed mesh technique
  • Active Comparator: Lichtenstein technique
    84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)
    Intervention: Procedure: Elliptical domed mesh technique
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
168
December 2011
December 2011   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Mexico
 
 
NCT01348477
R-2010-1005-10
Yes
Not Provided
Not Provided
Smolinski Kurek Rafal Ludwik, Mexican Social Security Institute
Instituto Mexicano del Seguro Social
Not Provided
Principal Investigator: Rafal L Smolinski, surgeon IMSS
Study Director: Martha A Hernandez, researcher IMSS
Study Chair: Sergio E Solorio, researcher IMSS
Instituto Mexicano del Seguro Social
September 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP