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

Incisional Hernia Clinical Trial

Official title:

Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00891254
• Other study ID #: HLS-2904009-03
• Status: Completed
• Phase: Phase 1
• First received: April 30, 2009
• Last updated: October 29, 2012
• Start date: January 2009
• Est. completion date: July 2012

Study information

• Verified date: October 2012
• Source: Cirujanos la Serena
• Contact: n/a
• Is FDA regulated: No
• Health authority: Chile: Instituto de Salud Pública de Chile
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 2012
• Est. primary completion date: January 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 75 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

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

Locations

Country	Name	City	State
Chile	Hospital de La Serena	La Serena	Iv Region

Sponsors (1)

Lead Sponsor	Collaborator
Cirujanos la Serena

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Long-term recurrence		5 years	No
Secondary	Short-term complications		1 year	No