Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00007242

Trial Description

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Title

Standardization of Laparoscopic Intraperitoneal Onlay Mesh Augmentation for Incisional Hernia Repair: Impact on Clinical Outcomes and Quality-of-Life - Open Prospective Observational Multicentre Cohort Study

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Trial Acronym

LIPOM

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00007242
  •   2015/04/29
  •   2014/03/15
  •   yes
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Secondary IDs

  •   NCT02089958  (ClinicalTrials.gov)
  •   AE 003  (Klinikum Fulda)
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Health Condition or Problem studied

  •   Incisional Hernia
  •   K43.0 -  Ventral hernia with obstruction, without gangrene
  •   K43.1 -  Ventral hernia with gangrene
  •   K43.2 -  [generalization K43: Ventral hernia]
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Interventions/Observational Groups

  •   Procedure: Laparoscopic incisional hernia repair
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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Recurrence rate; time frame: until 12 mths postoperatively

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Secondary Outcome

- Pain, Quality of Life; time frame: until 12 mths postoperatively; Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/09/30
  •   100
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional 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

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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

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Addresses

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    • Klinikum Fulda
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    • Johnson & Johnson
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    • Klinikum Fulda
    • Achim Hellinger, MD, PhD 
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    • Katja Dehler, CS 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/11/05
* This entry means the parameter is not applicable or has not been set.