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

Instituto Mexicano del Seguro Social

Status: Unknown

Conditions: Inguinal Hernia

Treatments: Procedure: Elliptical domed mesh technique

Study type: Interventional

Funder types: Other

Identifiers

NCT01348477

R-2010-1005-10

Details and patient eligibility

About

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.

Full 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.

Enrollment: 168 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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168 participants in 2 patient groups

Elliptical domed mesh technique

Experimental group

Description:

84 adult patients with primary uncomplicated inguinal hernia, treated with an open preperitoneal elliptical mesh technique

Treatment:

Procedure: Elliptical domed mesh technique

Lichtenstein technique

Active Comparator group

Description:

84 adult patients with primary uncomplicated inguinal hernia treated with the Lichtenstein technique (gold standard)

Treatment:

Procedure: Elliptical domed mesh technique