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

Primary Purpose

Incisional Ventral Hernia, Recurrent Ventral Hernia

Status

Completed

Phase

Not Applicable

Locations

Croatia

Study Type

Interventional

Intervention

modified "open mesh technique"

About this trial

This is an interventional treatment trial for Incisional Ventral Hernia focused on measuring ventral hernia, infection, hematoma, seroma, recurrence, mesh technique

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Varazdin General Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

modified "open mesh technique"

Arm Description

We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.

Outcomes

Primary Outcome Measures

number/frequency of early postoperative complications (wound infections, seroma, hematoma)

Secondary Outcome Measures

postoperative hernia recurrence

Full Information

NCT ID

NCT01953302

First Posted

September 21, 2013

Last Updated

April 17, 2017

Sponsor

Varazdin General Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01953302

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2017

Overall Recruitment Status

Completed

Study Start Date

May 2010 (undefined)

Primary Completion Date

May 2014 (Actual)

Study Completion Date

May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Varazdin General Hospital

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Incisional Ventral Hernia, Recurrent Ventral Hernia

Keywords

ventral hernia, infection, hematoma, seroma, recurrence, mesh technique

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

124 (Actual)

8. Arms, Groups, and Interventions

Arm Title

modified "open mesh technique"

Arm Type

Experimental

Arm Description

We performed an "open" intraperitoneal mesh technique in all patients: we placed surgical mesh of appropriate size intraperitoneally with transfascial fixation and drainage.

Intervention Type

Procedure

Intervention Name(s)

modified "open mesh technique"

Other Intervention Name(s)

Proceed Surgical Mesh, VycrilTM,2-0 resorbing sutures

Intervention Description

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.

Primary Outcome Measure Information:

Title

number/frequency of early postoperative complications (wound infections, seroma, hematoma)

Time Frame

four weeks after the surgery

Secondary Outcome Measure Information:

Title

postoperative hernia recurrence

Time Frame

up to 36 months after the surgery

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ranko Stare, MD, PhD

Organizational Affiliation

Varazdin General Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

Varazdin General Hospital

City

Varazdin

ZIP/Postal Code

HR-42000

Country

Croatia

12. IPD Sharing Statement

Citations:

PubMed Identifier

27209474

Citation

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.

Results Reference

result

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

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