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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00891254
First Posted: May 1, 2009
Last Update Posted: October 31, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MARCELO A. BELTRAN, M.D., Cirujanos la Serena
  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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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 MARCELO A. BELTRAN, M.D., Cirujanos la Serena:

Primary Outcome Measures:
  • Long-term recurrence [ Time Frame: 5 years ]

Secondary Outcome Measures:
  • Short-term complications [ Time Frame: 1 year ]

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

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Ages Eligible for Study:   35 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: April 30, 2009
First Posted: May 1, 2009
Last Update Posted: October 31, 2012
Last Verified: October 2012

Keywords provided by MARCELO A. BELTRAN, M.D., 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
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes