Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh

Cirujanos la Serena80 enrolled

Overview

The intraperitoneal repair has been proven safe for the repair of incisional hernia and is accepted, together with the subfascial or retromuscular repair as the "gold-standard" for the repair of incisional hernia. However no studies have convincingly proven that this approach is better than the on-lay repair. The authors believe that the intraperitoneal repair performs better than the on-lay repair for incisional hernia.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Incisional Hernia

Interventions

Implant of a prosthetic meshDEVICE

A prosthetic mesh will be implanted either intraperitoneally or in the on-lay (supra-fascial) position depending on the arm of the study

Eligibility

Sex: ALLMin age: 35 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients with incisional hernia 5 cm of diameter or with an area of 25 square cm (cm2) * First repair * Older than 35 years of age and younger than 75 years of age * Both genders * Any BMI * Only upper abdominal midline incisional hernias (supraumbilical) * Patients submitted only to elective repair Exclusion Criteria: * Recurrent incisional hernia * Emergency surgery * Hernias with a diameter higher than 5 cm or more than 25 cm2 of area * Lower midline abdominal incisional hernias * Other hernias rather than midline incisional hernias * Non-incisional hernias

Locations (1)

Hospital de La Serena

La Serena, Coquimbo Region, Chile

Outcomes

Primary Outcomes

Long-term recurrence

Time frame: 5 years

Secondary Outcomes

Short-term complications

Time frame: 1 year

Data from ClinicalTrials.gov

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