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Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varazdin General Hospital
ClinicalTrials.gov Identifier:
NCT01953302
First received: September 21, 2013
Last updated: April 17, 2017
Last verified: April 2017
  Purpose
Ventral hernias, primary and recurrent, are major surgical challenge. We aim to investigate efficacy of modified technique of ventral hernias repair: an "open intraperitoneal mesh" technique.

Condition Intervention
Incisional Ventral Hernia
Recurrent Ventral Hernia
Procedure: modified "open mesh technique"

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: No masking
Primary Purpose: Treatment
Official Title: Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair

Resource links provided by NLM:


Further study details as provided by Varazdin General Hospital:

Primary Outcome Measures:
  • number/frequency of early postoperative complications (wound infections, seroma, hematoma) [ Time Frame: four weeks after the surgery ]

Secondary Outcome Measures:
  • postoperative hernia recurrence [ Time Frame: up to 36 months after the surgery ]

Enrollment: 124
Study Start Date: May 2010
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: modified "open mesh technique"
We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.
Procedure: modified "open mesh technique"
We positioned mesh intraperitoneally so it can provide adequate mechanical support to the weakened abdominal wall. We also preserved hernia sack to conceal the mesh.
Other Names:
  • Proceed Surgical Mesh
  • VycrilTM,2-0 resorbing sutures

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients aged 18 years or older
  • American Society of Anesthesiologists physical status I, II, III

Exclusion Criteria:

  • refusal of the patients to give informed consent
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01953302

Locations
Croatia
Varazdin General Hospital
Varazdin, Croatia, HR-42000
Sponsors and Collaborators
Varazdin General Hospital
Investigators
Principal Investigator: Ranko Stare, MD, PhD Varazdin General Hospital
  More Information

Publications:
Responsible Party: Varazdin General Hospital
ClinicalTrials.gov Identifier: NCT01953302     History of Changes
Other Study ID Numbers: 24011983
Study First Received: September 21, 2013
Last Updated: April 17, 2017

Keywords provided by Varazdin General Hospital:
ventral hernia
infection
hematoma
seroma
recurrence
mesh technique

Additional relevant MeSH terms:
Hernia
Hernia, Ventral
Pathological Conditions, Anatomical
Hernia, Abdominal

ClinicalTrials.gov processed this record on April 21, 2017