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

Not Applicable

• Conditions: Inguinal Hernia
• Interventions: Procedure: Elliptical domed mesh technique

• Registration Number: NCT01348477
• Lead Sponsor: Instituto Mexicano del Seguro Social

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.

Study Timeline

• Status Verified: 2010-09
• Study Start: 2010-10
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-05-04
• Last Update Submitted: 2011-05-04
• Study First Posted: 2011-05-05
• Last Update Posted: 2011-05-05
• Primary Completion: 2011-12
• Study Completion: 2011-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 168

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Elliptical domed mesh technique	Elliptical domed mesh technique	84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique
Lichtenstein technique	Elliptical domed mesh technique	84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)

Primary Outcome Measures

Name	Time	Method
pain one month after surgery	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	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	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.

Secondary Outcome Measures

Name	Time	Method
dysesthesia one month after surgery	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	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	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.

Trial Locations

Locations (1)

Ambulatory care medical unit number 55 (UMAA 55); 🇲🇽 Leon, Guanajuato, Mexico