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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MARCELO A. BELTRAN, M.D., Cirujanos la Serena
ClinicalTrials.gov Identifier:
NCT00891254
First received: April 30, 2009
Last updated: October 29, 2012
Last verified: October 2012
History of Changes

April 30, 2009
October 29, 2012
January 2009
January 2011   (final data collection date for primary outcome measure)
Long-term recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00891254 on ClinicalTrials.gov Archive Site
Short-term complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh
Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair

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.
Not Provided
Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Incisional Hernia
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
  • Active Comparator: 1. Intraperitoneal repair
    Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery
    Intervention: Device: Implant of a prosthetic mesh
  • Active Comparator: 2. On-Lay repair
    Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery
    Intervention: Device: Implant of a prosthetic mesh
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
80
July 2012
January 2011   (final data collection date for primary outcome measure)

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
Both
35 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
Chile
 
NCT00891254
HLS-2904009-03
No
MARCELO A. BELTRAN, M.D., Cirujanos la Serena
Cirujanos la Serena
Not Provided
Principal Investigator: MARCELO A BELTRAN, M.D. HOSPITAL DE LA SERENA
Cirujanos la Serena
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP