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
Recruitment status was Recruiting
Sponsor:
Instituto Mexicano del Seguro Social
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
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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:
Genetics Home Reference related topics:
abdominal wall defect
MedlinePlus related topics:
Hernia
U.S. FDA Resources
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
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 Pathological Conditions, Anatomical Hernia, Abdominal |
ClinicalTrials.gov processed this record on May 16, 2013