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

NCT ID: NCT01953302

Last Updated: 2024-04-12

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-05-31

Study Completion Date

2014-05-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Incisional Ventral Hernia Recurrent Ventral Hernia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

modified "open mesh technique"

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type PROCEDURE

Other Intervention Names

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Proceed Surgical Mesh VycrilTM,2-0 resorbing sutures

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Varazdin General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ranko Stare, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Varazdin General Hospital

Locations

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Varazdin General Hospital

Varaždin, , Croatia

Site Status

Countries

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Croatia

References

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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.

Reference Type RESULT
PMID: 27209474 (View on PubMed)

Other Identifiers

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24011983

Identifier Type: -

Identifier Source: org_study_id

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