Umbilical HerniaHUMPNCT00789230
Mesh Versus Suture Repair for Umbilical Hernias
A study testing primary suture closure and mesh enforced closure in people with Umbilical Hernia, run by Ruth Kaufmann, MD at 12 sites in 3 countries.
Trial summary
The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Umbilical Hernia
- What is being tested?
- primary suture closure and mesh enforced closure
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 12 sitesin 3 countries
- Study dates
- Jan 2006to Aug 2015
- Phase
- Interventional
- 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
Who may be able to join
- Primary umbilical hernia
- Signed Informed consent
Who cannot join
- Umbilical hernia ≥ 4 cm diameter
- Recurrence
- Midline laparotomy
- Ascites/Cirrhosis
- ASA score IV or above
- Incarcerated hernia/emergency procedures
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
Netherlands9 sites
Onze Lieve Vrouwe Gasthuis
Amsterdam
Wilhelmina Ziekenhuis
Assen
Reinier de Graaf Gasthuis
Delft
Erasmus University Medical Center
Rotterdam, South Holland, 3015CN
Havenziekenhuis
Rotterdam
Ikazia
Rotterdam
Maasstad Ziekenhuis
Rotterdam
Máxima Medisch Centrum
Veldhoven
Isala
Zwolle
Germany2 sites
Studienzentrum der Deutschen Gesellschaft für Chirurgie
Heidelberg
University of Witten/Herdecke
Witten
About this study
Official title: Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial
The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). Especially risk factors for hernia recurrence such as hernia size and BMI > 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.
Read the detailed description
Purpose The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). Especially risk factors for hernia recurrence such as hernia size and BMI > 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.
Study design Randomised controlled, double blinded, multi-centre trial. 300 consecutive patients with an umbilical hernia will be included in the study. Patients will be randomised in one of two groups of 150 patients each. Group 1 will include patients that will undergo primary (suture) repair; group 2 umbilical hernias will be repaired using a pre-peritoneal, flat polypropylene mesh in a tension free fashion.
Stratification will be utilized for the size of the hernia (1-2 cm or ≥2-4 cm) and the participating centre. Patients will visit the outpatient clinic after 2-3 weeks and after 3, 12 and 24 months.
The cumulative hernia recurrence rate during the 2-years follow-up period will be the primary outcome of the study. Complications, pain and QOL are secondary endpoints.
Statistical analysis All analyses will be performed according to the intention to treat principle and as specified in the protocol.
Financial support None.
- Conditions
- Umbilical Hernia
- Being tested
- primary suture closure, mesh enforced closure
- Keywords
- umbilical, hernia, mesh
- Medical subject headings
- Hernia, Umbilical, Hernia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
primary suture closureProcedure or surgery
primary suture closure of hernia
mesh enforced closureDevice
mesh enforced closure of hernia
| Study group | Role | What they receive |
|---|---|---|
| primary suture | Active comparator | Not described Receives: Procedure: primary suture closure |
| mesh enforced closure | Active comparator | Not described Receives: Device: mesh enforced closure |
What is being measured
The primary outcome is the main question the study is designed to answer.
hernia recurrence rate
Measured: 24 months
Secondary outcomes (1)
Post-operative morbidity and complications
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2008 (estimated)
- Study startJan 2006
- Primary completionApr 2015
- Study completionAug 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 Umbilical 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Suture versus mesh repair in umbilical hernia patients
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruth Kaufmann, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ruth Kaufmann, MD, Erasmus Medical Center
- Investigators
- J. Jeekel, MD, PhD, Principal investigator, Erasmus Medical CenterJ.F. Lange, MD, PhD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789230
- Sponsor's protocol ID
- HUMP
- Acronym
- HUMP
- Status last verified
- Feb 2018
- First submitted
- 9 Nov 2008
- Last updated
- 26 Feb 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaufmann R, Halm JA, Eker HH, Klitsie PJ, Nieuwenhuizen J, van Geldere D, Simons MP, van der Harst E, van 't Riet M, van der Holt B, Kleinrensink GJ, Jeekel J, Lange JF. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018 Mar 3;391(10123):860-869. doi: 10.1016/S0140-6736(18)30298-8. Epub 2018 Feb 17.
PubMed 29459021
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT00789230
- Acronym / sponsor ID
- HUMP / HUMP
- Conditions
- Umbilical Hernia
- Keywords
- umbilical, hernia, mesh
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Ruth Kaufmann, MDUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Apr 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 11 Nov 2008 (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.
The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). Especially risk factors for hernia recurrence such as hernia size and BMI > 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.
Detailed description
Purpose The purpose of the present study is to investigate whether or not the use of mesh is indicated in the repair of all size umbilical hernias as to reduce the rate of recurrence. This method is regularly used in umbilical hernia reconstruction although most surgeons repair small hernias using suture repair (fascia adaptation). Especially risk factors for hernia recurrence such as hernia size and BMI > 30 kg/m2 need to be evaluated and correlated to the method of hernia repair.
Study design Randomised controlled, double blinded, multi-centre trial. 300 consecutive patients with an umbilical hernia will be included in the study. Patients will be randomised in one of two groups of 150 patients each. Group 1 will include patients that will undergo primary (suture) repair; group 2 umbilical hernias will be repaired using a pre-peritoneal, flat polypropylene mesh in a tension free fashion.
Stratification will be utilized for the size of the hernia (1-2 cm or ≥2-4 cm) and the participating centre. Patients will visit the outpatient clinic after 2-3 weeks and after 3, 12 and 24 months.
The cumulative hernia recurrence rate during the 2-years follow-up period will be the primary outcome of the study. Complications, pain and QOL are secondary endpoints.
Statistical analysis All analyses will be performed according to the intention to treat principle and as specified in the protocol.
Financial support None.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Suture versus mesh repair in umbilical hernia patients
| Arm | Type | Receives |
|---|---|---|
| primary suture | Active comparator | Procedure: primary suture closure |
| mesh enforced closure | Active comparator | Device: mesh enforced closure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Primary umbilical hernia
- Signed Informed consent
Key exclusion criteria (6 listed)
- Umbilical hernia ≥ 4 cm diameter
- Recurrence
- Midline laparotomy
- Ascites/Cirrhosis
- ASA score IV or above
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 |
|---|---|---|
| primary suture closureprimary suture closure of hernia | Procedure or surgery | primary suture |
| mesh enforced closuremesh enforced closure of hernia | Device | mesh enforced closure |
Primary outcome
hernia recurrence rate
Time frame: 24 months
1 secondary outcome
Post-operative morbidity and complications
Time frame: 3 months
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 26 Feb 2018.
- Derived from this study: PubMed 29459021Kaufmann R, Halm JA, Eker HH, Klitsie PJ, Nieuwenhuizen J, van Geldere D, Simons MP, van der Harst E, van 't Riet M, van der Holt B, Kleinrensink GJ, Jeekel J, Lange JF. Mesh versus suture repair of umbilical hernia in adults: a randomised, double-blind, controlled, multicentre trial. Lancet. 2018 Mar 3;391(10123):860-869. doi: 10.1016/S0140-6736(18)30298-8. Epub 2018 Feb 17.
- Individual participant dataSharing planned: No
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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.
J. Jeekel, MD, PhD principal investigator
Erasmus Medical Center
J.F. Lange, MD, PhD principal investigator
Erasmus Medical Center
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing primary suture closure and mesh enforced closure in people with Umbilical Hernia, run by Ruth Kaufmann, MD at 12 sites in 3 countries.
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 2 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 26 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Netherlands, Germany, Italy. 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?
hernia recurrence rate (time frame: 24 months). 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 NCT00789230, 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 26 Feb 2018; AzTrials last refreshed its copy on 6 Nov 2026.