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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00891254
Other study ID # HLS-2904009-03
Secondary ID
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


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
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