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
  Purpose

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.


Condition Intervention Phase
Incisional Hernia
Device: Implant of a prosthetic mesh
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Study of Long-term Follow-up of Incisional Hernia Repaired With Intraperitoneal Mesh Versus On-lay Mesh Repair

Resource links provided by NLM:


Further study details as provided by Cirujanos la Serena:

Primary Outcome Measures:
  • Long-term recurrence [ Time Frame: 5 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Short-term complications [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 80
Study Start Date: January 2009
Study Completion Date: July 2012
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1. Intraperitoneal repair
Patients with incisional hernia, 5 cm in diameter or with an area of 25 cm2, submitted to elective surgery
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: 2. On-Lay repair
Patients with incisional hernia, with a diameter of 5 cm or an area of 25 cm2, submitted to elective surgery
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

  Eligibility

Ages Eligible for Study:   35 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00891254

Locations
Chile
Hospital de La Serena
La Serena, Iv Region, Chile, IV REGION
Sponsors and Collaborators
Cirujanos la Serena
Investigators
Principal Investigator: MARCELO A BELTRAN, M.D. HOSPITAL DE LA SERENA
  More Information

No publications provided

Responsible Party: MARCELO A. BELTRAN, M.D., DIGESTIVE SURGEON, Cirujanos la Serena
ClinicalTrials.gov Identifier: NCT00891254     History of Changes
Other Study ID Numbers: HLS-2904009-03
Study First Received: April 30, 2009
Last Updated: October 29, 2012
Health Authority: Chile: Instituto de Salud Publica de Chile

Keywords provided by Cirujanos la Serena:
Incisional hernia
Intraperitoneal mesh repair
On-lay repair
Prosthetic mesh
First repair (no recurrent hernia will be included)
Recurrence
Complications

Additional relevant MeSH terms:
Hernia
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on April 15, 2014