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

April 6, 2024 updated by: Varazdin General Hospital
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

We analyzed early postoperative complications (EPCs; wound infection, hematoma, and seroma) and late postoperative complications (recurrence) in 124 patients operated for IHs and recurrent IHs (RIHs) using our new technique. Our technique involved repairing hernias by preserving the hernia sac, which was later used to conceal the mesh that replaced the abdominal wall defect, thus dividing the mesh from subcutaneous tissue.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Croatia
      • Varazdin, Croatia, HR-42000
        • Varazdin General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Early Postoperative Complications (Wound Infections, Seroma, Hematoma)
Time Frame: four weeks after the surgery
we counted number of patinetns with wound infection, seroma, hematoma that occured in the early postoperative time
four weeks after the surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Number of Patients With Postoperative Hernia Recurrence
Time Frame: up to 36 months after the surgery
up to 36 months after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Varazdin General Hospital

Investigators

  • Principal Investigator: Ranko Stare, MD, PhD, Varazdin General Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2010

Primary Completion (Actual)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

September 21, 2013

First Submitted That Met QC Criteria

September 25, 2013

First Posted (Estimated)

September 30, 2013

Study Record Updates

Last Update Posted (Actual)

April 12, 2024

Last Update Submitted That Met QC Criteria

April 6, 2024

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 24011983

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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