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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2013 by Varazdin General Hospital.
Recruitment status was  Recruiting
Information provided by (Responsible Party):
Varazdin General Hospital Identifier:
First received: September 21, 2013
Last updated: April 24, 2014
Last verified: September 2013
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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair - a Pilot Study on 55 Patients

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • postoperative hernia recurrence [ Time Frame: up to 36 months after the surgery ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: May 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: September 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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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 identifier: NCT01953302

Contact: Anita Lukic, MD, PhD 00385958236723
Contact: Alen Pajtak, MD 00385981918289

Varazdin General Hospital Recruiting
Varazdin, Croatia, HR-42000
Contact: Anita Lukic, MD, PhD    00385958236723   
Contact: Alen Pajtak, MD    00385981918289   
Sub-Investigator: Alen Pajtak, MD         
Principal Investigator: Ranko Stare, MD, PhD         
Sub-Investigator: Sandra Skorjanec, MD, PhD         
Sub-Investigator: Ivica Biskup, MD         
Sub-Investigator: Krunoslav Hrzenjak, MD         
Sub-Investigator: Anita Lukic, MD, PhD         
Sponsors and Collaborators
Varazdin General Hospital
Principal Investigator: Ranko Stare, MD, PhD Varazdin General Hospital
  More Information

No publications provided

Responsible Party: Varazdin General Hospital Identifier: NCT01953302     History of Changes
Other Study ID Numbers: 24011983
Study First Received: September 21, 2013
Last Updated: April 24, 2014
Health Authority: Croatia: Ethics Committee

Keywords provided by Varazdin General Hospital:
ventral hernia
mesh technique

Additional relevant MeSH terms:
Hernia, Ventral
Hernia, Abdominal
Pathological Conditions, Anatomical processed this record on November 27, 2015