Standardization of Laparoscopic Hernia Repair

Incisional Hernia Clinical Trial

— LIPOM  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02089958
• Other study ID #: AE 003
• Status: Completed
• Phase: N/A
• First received: March 15, 2014
• Last updated: September 15, 2016
• Start date: September 2013
• Est. completion date: October 2015

Study information

• Verified date: September 2016
• Source: Klinikum Fulda
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Description:

Data are scheduled for publication.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 102
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hernia
• Incisional Hernia

Intervention

Procedure:
• Laparoscopic incisional hernia repair
Standardized laparoscopic incisional hernia repair with mesh

Locations

Country	Name	City	State
Germany	Klinikum Fulda	Fulda	Hessen

Sponsors (2)

Lead Sponsor	Collaborator
Klinikum Fulda	Johnson & Johnson

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Wound infection	Measured along SSI-classification	12 mts postoperatively	No
Primary	Recurrence rate		until 12 mths postoperatively	No
Secondary	Pain, Quality of Life	Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.	until 12 mths postoperatively	No