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

Cirujanos la Serena

Status and phase: Completed; Phase 1

Conditions: Incisional Hernia

Treatments: Device: Implant of a prosthetic mesh

Study type: Interventional

Funder types: Other

Identifiers

NCT00891254

HLS-2904009-03

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: All

Ages: 35 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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80 participants in 2 patient groups

1. Intraperitoneal repair

Active Comparator group

Description:

Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery

Treatment:

Device: Implant of a prosthetic mesh

2. On-Lay repair

Active Comparator group

Description:

Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery

Treatment:

Device: Implant of a prosthetic mesh