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

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ClinicalTrials.gov Identifier: NCT01953302
Recruitment Status : Completed
First Posted : September 30, 2013
Last Update Posted : April 19, 2017
Sponsor:
Information provided by (Responsible Party):
Varazdin General Hospital

Brief Summary:
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 or disease Intervention/treatment Phase
Incisional Ventral Hernia Recurrent Ventral Hernia Procedure: modified "open mesh technique" Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 124 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
Study Start Date : May 2010
Actual Primary Completion Date : May 2014
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia
U.S. FDA Resources

Arm Intervention/treatment
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



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

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


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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

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): 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

Publications of Results:
Responsible Party: Varazdin General Hospital
ClinicalTrials.gov Identifier: NCT01953302     History of Changes
Other Study ID Numbers: 24011983
First Posted: September 30, 2013    Key Record Dates
Last Update Posted: April 19, 2017
Last Verified: April 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