Trial record 5 of 179 for:    Open Studies | Hernia NOT disc

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Varazdin General Hospital
Sponsor:
Information provided by (Responsible Party):
Varazdin General Hospital
ClinicalTrials.gov Identifier:
NCT01953302
First received: September 21, 2013
Last updated: April 24, 2014
Last verified: September 2013
  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: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
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: NCT01953302

Contacts
Contact: Anita Lukic, MD, PhD 00385958236723 lukic.anita@yahoo.com
Contact: Alen Pajtak, MD 00385981918289 alen@dvasadva.net

Locations
Croatia
Varazdin General Hospital Recruiting
Varazdin, Croatia, HR-42000
Contact: Anita Lukic, MD, PhD    00385958236723    lukic.anita@yahoo.com   
Contact: Alen Pajtak, MD    00385981918289    alen@dvasadva.net   
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
Investigators
Principal Investigator: Ranko Stare, MD, PhD Varazdin General Hospital
  More Information

No publications provided

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 24, 2014
Health Authority: Croatia: Ethics Committee

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 September 18, 2014