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Standardization of Laparoscopic Hernia Repair (LIPOM)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02089958
Recruitment Status : Completed
First Posted : March 18, 2014
Last Update Posted : September 16, 2016
Sponsor:
Collaborator:
Johnson & Johnson
Information provided by (Responsible Party):
Achim Hellinger, Klinikum Fulda

Brief Summary:
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.

Condition or disease Intervention/treatment
Incisional Hernia Procedure: Laparoscopic incisional hernia repair

Detailed Description:
Data are scheduled for publication.

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Study Type : Observational
Actual Enrollment : 102 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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
Study Start Date : September 2013
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hernia

Group/Cohort Intervention/treatment
Laparoscopic incisional hernia repair
Incisional hernia, LIPOM
Procedure: Laparoscopic incisional hernia repair
Standardized laparoscopic incisional hernia repair with mesh
Other Name: LIPOM




Primary Outcome Measures :
  1. Recurrence rate [ Time Frame: until 12 mths postoperatively ]

Secondary Outcome Measures :
  1. Pain, Quality of Life [ Time Frame: until 12 mths postoperatively ]
    Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.


Other Outcome Measures:
  1. Wound infection [ Time Frame: 12 mts postoperatively ]
    Measured along SSI-classification



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Pts. with incisional hernia following prior abdominal surgery
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02089958


Locations
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Germany
Klinikum Fulda
Fulda, Hessen, Germany, 36039
Sponsors and Collaborators
Klinikum Fulda
Johnson & Johnson
Investigators
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Study Chair: Achim Hellinger, MD, PhD Klinikum Fulda
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Achim Hellinger, Priv. Doz. Dr. med., Klinikum Fulda
ClinicalTrials.gov Identifier: NCT02089958    
Other Study ID Numbers: AE 003
First Posted: March 18, 2014    Key Record Dates
Last Update Posted: September 16, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: publication
Keywords provided by Achim Hellinger, Klinikum Fulda:
Lapraoscopy, incisional hernia repair, mesh
Additional relevant MeSH terms:
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Hernia
Incisional Hernia
Pathological Conditions, Anatomical
Postoperative Complications
Pathologic Processes