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Standardization of Laparoscopic Hernia Repair

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02089958
Acronym
LIPOM
Enrollment
102
Registered
2014-03-18
Start date
2013-09-30
Completion date
2015-10-31
Last updated
2016-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Incisional Hernia

Keywords

Lapraoscopy, incisional hernia repair, mesh

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.

Interventions

PROCEDURELaparoscopic incisional hernia repair

Standardized laparoscopic incisional hernia repair with mesh

Sponsors

Johnson & Johnson
CollaboratorINDUSTRY
Klinikum Fulda
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Recurrence rateuntil 12 mths postoperatively

Secondary

MeasureTime frameDescription
Pain, Quality of Lifeuntil 12 mths postoperativelyPain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.

Other

MeasureTime frameDescription
Wound infection12 mts postoperativelyMeasured along SSI-classification

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 12, 2026