Standardization of Laparoscopic Hernia Repair (LIPOM)

September 15, 2016 updated by: Achim Hellinger, Klinikum Fulda

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Data are scheduled for publication.

Study Type

Observational

Enrollment (Actual)

102

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Hessen
      • Fulda, Hessen, Germany, 36039
        • Klinikum Fulda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Pts. with incisional hernia following prior abdominal surgery

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Laparoscopic incisional hernia repair
Incisional hernia, LIPOM
Procedure: Laparoscopic incisional hernia repair
Standardized laparoscopic incisional hernia repair with mesh
Other Names:
  • LIPOM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Recurrence rate
Time Frame: until 12 mths postoperatively
until 12 mths postoperatively

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain, Quality of Life
Time Frame: until 12 mths postoperatively
Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.
until 12 mths postoperatively

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Wound infection
Time Frame: 12 mts postoperatively
Measured along SSI-classification
12 mts postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Klinikum Fulda

Collaborators

Johnson & Johnson

Investigators

  • Study Chair: Achim Hellinger, MD, PhD, Klinikum Fulda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2013

Primary Completion (Actual)

October 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

March 15, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (Estimate)

March 18, 2014

Study Record Updates

Last Update Posted (Estimate)

September 16, 2016

Last Update Submitted That Met QC Criteria

September 15, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AE 003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

publication

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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