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Prospective Study Of A Size Tailored Approach To Repair Umbilical And Epigastric Primary Ventral Hernias

NCT ID: NCT01639118

Last Updated: 2012-11-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

11 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-03-31

Study Completion Date

2012-08-31

Brief Summary

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Primary ventral hernias, such as umbilical and epigastric hernias, are best repaired with abdominal wall reinforcement by mesh implantation. Mesh-devices using a dual-sided mesh technology have been developed for the specific indication of small ventral hernias; this technique is very attractive because the mesh can be introduced through a nearly invisible scar in the umbilicus. The dual layer of the mesh inhibits the formation of adhesions of the viscera to the mesh so, if wanted, it can be positioned in a intraperitoneal position. No literature is available on the adequate size of mesh needed to repair a hernia defect of an umbilical or epigastric hernia. Very small hernias are now often enlarged for repair with a large mesh device. Small hernias might benefit of repair with a small mesh device so no enlargement of the defect is necessary Larger hernias might benefit from a larger mesh size to have more overlap of the mesh beyond the hernia defect.

With this prospective cohort study the investigators want to explore the efficacy of C-QUR V-Patch of different sizes for the different sizes of hernia defects.

Detailed Description

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Conditions

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Ventral Hernia Umbilical Hernia Epigastric Hernia

Keywords

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primary ventral hernia repair with mesh umbilical hernia repair epigastric hernia repair C-Qur V-patch Size tailored repair preperitoneal repair abdominal hernia dual sided mesh

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* all adult patients that are planned for surgical repair of a primary umbilical or epigastric hernia will be considered to enter the study.

Exclusion Criteria

* patients refusing to participate at the follow up visits
* pregnancy
* age \< 18 years
* life expectancy less than 12 months
* recurrent umbilical or epigastric hernia
* incisional or trocar site hernias
* emergency operations
* liver cirrhosis or ascites
* cancer patients
* concomitant surgery
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Algemeen Ziekenhuis Maria Middelares

OTHER

Sponsor Role lead

Responsible Party

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Stijn De Sutter

Dr. Stijn De Sutter

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stijn De Sutter, MD

Role: PRINCIPAL_INVESTIGATOR

Algemeen Ziekenhuis Maria Middelares

Filip Muysoms, MD

Role: STUDY_DIRECTOR

Algemeen Ziekenhuis Maria Middelares

Iris Kyle-Leinhase, PhD

Role: STUDY_CHAIR

Algemeen Ziekenhuis Maria Middelares

Locations

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AZ Maria Middelares

Ghent, Oost Vlaanderen, Belgium

Site Status

Countries

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Belgium

Other Identifiers

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SITUP-2012

Identifier Type: -

Identifier Source: org_study_id