Standardization of Laparoscopic Hernia Repair
LIPOM
1 other identifier
observational
102
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2013
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 15, 2014
CompletedFirst Posted
Study publicly available on registry
March 18, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedSeptember 16, 2016
September 1, 2016
2.1 years
March 15, 2014
September 15, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Recurrence rate
until 12 mths postoperatively
Secondary Outcomes (1)
Pain, Quality of Life
until 12 mths postoperatively
Other Outcomes (1)
Wound infection
12 mts postoperatively
Study Arms (1)
Laparoscopic incisional hernia repair
Incisional hernia, LIPOM
Interventions
Standardized laparoscopic incisional hernia repair with mesh
Eligibility Criteria
Pts. with incisional hernia following prior abdominal surgery
You may qualify if:
- 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
You may not qualify if:
- Recurrent incisional hernia
- Ventral hernie
- Hernia size \> EHS W 2
- Hernia location EHS L 4, ASA \>3
- Prospective mesh overlap \< 5 cm
- Malignant disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Klinikum Fuldalead
- Johnson & Johnsoncollaborator
Study Sites (1)
Klinikum Fulda
Fulda, Hesse, 36039, Germany
Related Publications (1)
Hellinger A, Wotzlaw F, Fackeldey V, Pistorius G, Zdichavsky M, Junemann R, Buia A. Development of an open prospective observational multicentre cohort study to determine the impact of standardization of laparoscopic intraperitoneal onlay mesh repair (IPOM) for incisional hernia on clinical outcome and quality of life (LIPOM-Trial). Contemp Clin Trials Commun. 2016 Aug 11;4:118-123. doi: 10.1016/j.conctc.2016.08.001. eCollection 2016 Dec 15.
PMID: 29736474DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Achim Hellinger, MD, PhD
Klinikum Fulda
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Priv. Doz. Dr. med.
Study Record Dates
First Submitted
March 15, 2014
First Posted
March 18, 2014
Study Start
September 1, 2013
Primary Completion
October 1, 2015
Study Completion
October 1, 2015
Last Updated
September 16, 2016
Record last verified: 2016-09
Data Sharing
- IPD Sharing
- Will share
publication