Standardization of Laparoscopic Hernia Repair

Completed

• Conditions: Incisional Hernia

• Registration Number: NCT02089958
• Lead Sponsor: 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.

Detailed Description

Data are scheduled for publication.

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-03-15
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-18
• Primary Completion: 2015-10
• Study Completion: 2015-10
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-15
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Recurrence rate	until 12 mths postoperatively

Secondary Outcome Measures

Name	Time	Method
Pain, Quality of Life	until 12 mths postoperatively	Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.

Trial Locations

Locations (1)

Klinikum Fulda; 🇩🇪 Fulda, Hessen, Germany