Incisional HerniaLIPOMNCT02089958
Standardization of Laparoscopic Hernia Repair
An observational study of Incisional Hernia, run by Klinikum Fulda at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Incisional Hernia
- What is being tested?
- Laparoscopic incisional hernia repair
- Type of treatment
- Surgery or procedure
- How many people
- 102 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2013to Oct 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pts. with incisional hernia following prior abdominal surgery
Who may be able to join
- 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
Who cannot join
- Recurrent incisional hernia
- Ventral hernie
- Hernia size > EHS W 2
- Hernia location EHS L 4, ASA >3
- Prospective mesh overlap < 5 cm
- Malignant disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the detailed description
Data are scheduled for publication.
- Conditions
- Incisional Hernia
- Being tested
- Laparoscopic incisional hernia repair
- Keywords
- Lapraoscopy, incisional hernia repair, mesh
- Medical subject headings
- Incisional Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic incisional hernia repairProcedure or surgery
Also called LIPOM
Standardized laparoscopic incisional hernia repair with mesh
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopic incisional hernia repair | Incisional hernia, LIPOM Receives: Procedure: Laparoscopic incisional hernia repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recurrence rate
Measured: until 12 mths postoperatively
Secondary outcomes (1)
Pain, Quality of Life
Pain measured by numeric rating scale. QoL measured by Carolina Comfort Scale.
Measured: until 12 mths postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2014 (estimated)
- Study startSep 2013
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Incisional HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Fulda
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson
- Responsible party
- Principal investigator, Achim Hellinger, Klinikum Fulda
- Investigators
- Achim Hellinger, MD, PhD, Study chair, Klinikum Fulda
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089958
- Sponsor's protocol ID
- AE 003
- Acronym
- LIPOM
- Status last verified
- Sep 2016
- First submitted
- 15 Mar 2014
- Last updated
- 16 Sep 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: publication
Publications
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.
PubMed 29736474
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02089958
- Acronym / sponsor ID
- LIPOM / AE 003
- Conditions
- Incisional Hernia
- Keywords
- Lapraoscopy, incisional hernia repair, mesh
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Klinikum FuldaUniversity, hospital or other
- Collaborators
- Johnson & Johnson
- Study start
- Sep 2013
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 18 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laparoscopic incisional hernia repair | – | Procedure: Laparoscopic incisional hernia repairIncisional hernia, LIPOM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pts. with incisional hernia following prior abdominal surgery
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Recurrent incisional hernia
- Ventral hernie
- Hernia size > EHS W 2
- Hernia location EHS L 4, ASA >3
- Prospective mesh overlap < 5 cm
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Laparoscopic incisional hernia repairAlso: LIPOMStandardized laparoscopic incisional hernia repair with mesh | Procedure or surgery | Laparoscopic incisional hernia repair |
Primary outcome
Recurrence rate
Time frame: until 12 mths postoperatively
1 secondary outcome
Pain, Quality of Life
Time frame: until 12 mths postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2016.
- Derived from this study: PubMed 29736474Hellinger 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.
- Individual participant dataSharing planned: Yes. publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Achim Hellinger, MD, PhD study chair
Klinikum Fulda
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Incisional Hernia, run by Klinikum Fulda at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recurrence rate (time frame: until 12 mths postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02089958, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2016.