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.

Study Overview

• Status: Unknown
• Conditions: Inguinal Hernia
• Intervention / Treatment: Procedure: Elliptical domed mesh technique

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 Type: Interventional
• Enrollment (Anticipated): 168
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Mexico
  • Guanajuato
    • Leon, Guanajuato, Mexico
      • Recruiting
      • Ambulatory care medical unit number 55 (UMAA 55)
      • Contact: Rafal L Smolinski, surgeon; Phone Number: 52-477-7768584; Email: ludwiksrk@hotmail.com
      • Contact: Sergio E Solorio, researcher; Phone Number: 52-477-7174800; Email: 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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 Names: 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 Names: preperitoneal mesh

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: October 1, 2010
• Primary Completion (Anticipated): December 1, 2011
• Study Completion (Anticipated): December 1, 2011

Study Registration Dates

• First Submitted: May 2, 2011
• First Submitted That Met QC Criteria: May 4, 2011
• First Posted (Estimate): May 5, 2011

Study Record Updates

• Last Update Posted (Estimate): May 5, 2011
• Last Update Submitted That Met QC Criteria: May 4, 2011
• Last Verified: September 1, 2010

More Information

Terms related to this study

• Keywords: pain; hernia; inguinal; mesh; inguinodynia
• Additional Relevant MeSH Terms: Pathological Conditions, Anatomical; Hernia, Abdominal; Hernia; Hernia, Inguinal
• Other Study ID Numbers: R-2010-1005-10