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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Pública 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 October 19, 2014