Modified "Open Intraperitoneal Mesh" Technique of Incisional Ventral Hernia Repair
1 other identifier
interventional
124
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started May 2010
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
September 21, 2013
CompletedFirst Posted
Study publicly available on registry
September 30, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
April 12, 2024
CompletedApril 12, 2024
April 1, 2017
4 years
September 21, 2013
August 31, 2023
April 6, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time
four weeks after the surgery
Secondary Outcomes (1)
Number of Patients With Postoperative Hernia Recurrence
up to 36 months after the surgery
Study Arms (1)
modified "open mesh technique"
EXPERIMENTALWe performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients aged 18 years or older
- American Society of Anesthesiologists physical status I, II, III
You may not qualify if:
- refusal of the patients to give informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Varazdin General Hospital
Varaždin, HR-42000, Croatia
Related Publications (1)
Pajtak A, Stare R, Biskup I, Lukic A, Skorjanec S, Hrzenjak K. A modified open intraperitoneal mesh (Garestin) technique for incisional ventral hernia repair. Asian J Surg. 2017 Jul;40(4):278-284. doi: 10.1016/j.asjsur.2016.02.001. Epub 2016 May 18.
PMID: 27209474RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Alen Pajtak
- Organization
- Varazdin General Hospital
Study Officials
- PRINCIPAL INVESTIGATOR
Ranko Stare, MD, PhD
Varazdin General Hospital
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 21, 2013
First Posted
September 30, 2013
Study Start
May 1, 2010
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
April 12, 2024
Results First Posted
April 12, 2024
Record last verified: 2017-04