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

Inguinal Hernia Clinical Trial

Official title:

Comparison Between Elliptical Domed Mesh Technique and Lichtenstein Technique, to Reduce Postoperative Pain in Open Inguinal Hernia Repair

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01348477
• Other study ID #: R-2010-1005-10
• Status: Recruiting
• Phase: N/A
• First received: May 2, 2011
• Last updated: May 4, 2011
• Start date: October 2010
• Est. completion date: December 2011

Study information

• Verified date: September 2010
• Source: Instituto Mexicano del Seguro Social
• Contact: Rafal L Smolinski, surgeon
• Phone: 52-477-7768584
• Email: ludwiksrk[@]hotmail.com
• Is FDA regulated: No
• Health authority: Mexico: Coordinación de Investigación en Salud
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 168
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Hernia, Inguinal
• Inguinal Hernia

Intervention

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

Locations

Country	Name	City	State
Mexico	Ambulatory care medical unit number 55 (UMAA 55)	Leon	Guanajuato

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Mexicano del Seguro Social

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Primary	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	No
Secondary	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.	one month	No
Secondary	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.	three months	No
Secondary	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.	six months	No