Standardization of Laparoscopic Hernia Repair

NCT ID: NCT02089958

Last Updated: 2016-09-16

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

COMPLETED

Total Enrollment

102 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-10-31

Brief Summary

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Incisional hernias are one of the most frequent complications in abdominal surgery. Laparoscopic repair is widely used but even not standardized. Existing data from different study designs show no representative data resulting in a lack of comparability and evidence. Therefore the standardization of operative techique has been proposed by the LIPOM-study group and will be assessed in a prospective manner.

Detailed Description

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Data are scheduled for publication.

Conditions

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Incisional Hernia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Laparoscopic incisional hernia repair

Incisional hernia, LIPOM

Laparoscopic incisional hernia repair

Intervention Type PROCEDURE

Standardized laparoscopic incisional hernia repair with mesh

Interventions

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Laparoscopic incisional hernia repair

Standardized laparoscopic incisional hernia repair with mesh

Intervention Type PROCEDURE

Other Intervention Names

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LIPOM

Eligibility Criteria

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Inclusion Criteria

* Primary incisional hernia
* Hernia size EHS W 1-2
* Hernia location EHS M 1-5, L 1-3
* Clinical symptoms or progressive growth of hernia

Exclusion Criteria

* Recurrent incisional hernia
* Ventral hernie
* Hernia size \> EHS W 2
* Hernia location EHS L 4, ASA \>3
* Prospective mesh overlap \< 5 cm
* Malignant disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Johnson & Johnson

INDUSTRY

Sponsor Role collaborator

Klinikum Fulda

OTHER

Sponsor Role lead

Responsible Party

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Achim Hellinger

Priv. Doz. Dr. med.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Achim Hellinger, MD, PhD

Role: STUDY_CHAIR

Klinikum Fulda

Locations

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Klinikum Fulda

Fulda, Hesse, Germany

Site Status

Countries

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Germany

References

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Hellinger A, Wotzlaw F, Fackeldey V, Pistorius G, Zdichavsky M, Junemann R, Buia A. Development of an open prospective observational multicentre cohort study to determine the impact of standardization of laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia on clinical outcome and quality of life (LIPOM-Trial). Contemp Clin Trials Commun. 2016 Aug 11;4:118-123. doi: 10.1016/j.conctc.2016.08.001. eCollection 2016 Dec 15.

Reference Type DERIVED
PMID: 29736474 (View on PubMed)

Other Identifiers

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AE 003

Identifier Type: -

Identifier Source: org_study_id

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