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OpenTrials
Completed

NCT Number: NCT02089958

Standardization of Laparoscopic Hernia Repair

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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Key information

Conditions

Incisional Hernia Hernia Pathologic Processes Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Postoperative Complications

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Klinikum Fulda

Fulda, Hesse, 36039, Germany

About this study

Data are scheduled for publication.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Laparoscopic incisional hernia repair

Procedure

Standardized laparoscopic incisional hernia repair with mesh

Other names: LIPOM

Primary outcomes

  1. Recurrence rate

    Time frame: until 12 mths postoperatively

Secondary outcomes

  1. Pain, Quality of Life

    Time frame: until 12 mths postoperatively

    Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.

Other outcomes

  1. Wound infection

    Time frame: 12 mts postoperatively

    Measured along SSI-classification

Sponsors and collaborators

Lead sponsor

Klinikum Fulda

Other

Collaborators

  • Johnson & Johnson

Registry information

Official study 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

Acronym: LIPOM

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Mar 18, 2014
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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