Mesh Versus Suture Repair for Umbilical Hernias (HUMP)
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| ClinicalTrials.gov Identifier: NCT00789230 |
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Recruitment Status :
Completed
First Posted : November 11, 2008
Last Update Posted : February 26, 2018
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Umbilical Hernia | Procedure: primary suture closure Device: mesh enforced closure | Not Applicable |
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 Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 300 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Suture versus mesh repair in umbilical hernia patients |
| Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial |
| Study Start Date : | January 2006 |
| Actual Primary Completion Date : | April 2015 |
| Actual Study Completion Date : | August 2015 |
| Arm | Intervention/treatment |
|---|---|
| Active Comparator: primary suture |
Procedure: primary suture closure
primary suture closure of hernia |
| Active Comparator: mesh enforced closure |
Device: mesh enforced closure
mesh enforced closure of hernia |
- hernia recurrence rate [ Time Frame: 24 months ]
- Post-operative morbidity and complications [ Time Frame: 3 months ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Primary umbilical hernia
- Signed Informed consent
Exclusion Criteria:
- Umbilical hernia ≥ 4 cm diameter
- Recurrence
- Midline laparotomy
- Ascites/Cirrhosis
- ASA score IV or above
- Incarcerated hernia/emergency procedures
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789230
| Germany | |
| Studienzentrum der Deutschen Gesellschaft für Chirurgie | |
| Heidelberg, Germany | |
| University of Witten/Herdecke | |
| Witten, Germany | |
| Italy | |
| Multimedica | |
| Milano, Italy | |
| Netherlands | |
| Erasmus University Medical Center | |
| Rotterdam, Zuid Holland, Netherlands, 3015CN | |
| Onze Lieve Vrouwe Gasthuis | |
| Amsterdam, Netherlands | |
| Wilhelmina Ziekenhuis | |
| Assen, Netherlands | |
| Reinier de Graaf Gasthuis | |
| Delft, Netherlands | |
| Havenziekenhuis | |
| Rotterdam, Netherlands | |
| Ikazia | |
| Rotterdam, Netherlands | |
| Maasstad Ziekenhuis | |
| Rotterdam, Netherlands | |
| Máxima Medisch Centrum | |
| Veldhoven, Netherlands | |
| Isala | |
| Zwolle, Netherlands | |
| Principal Investigator: | J. Jeekel, MD, PhD | Erasmus Medical Center | |
| Principal Investigator: | J.F. Lange, MD, PhD | Erasmus Medical Center |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ruth Kaufmann, MD, R. Kaufmann, Erasmus Medical Center |
| ClinicalTrials.gov Identifier: | NCT00789230 History of Changes |
| Other Study ID Numbers: |
HUMP |
| First Posted: | November 11, 2008 Key Record Dates |
| Last Update Posted: | February 26, 2018 |
| Last Verified: | February 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | No | |
| Studies a U.S. FDA-regulated Device Product: | No | |
Keywords provided by Ruth Kaufmann, MD, Erasmus Medical Center:
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umbilical hernia mesh |
Additional relevant MeSH terms:
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Hernia Hernia, Umbilical Pathological Conditions, Anatomical |
Infant, Newborn, Diseases Hernia, Ventral Hernia, Abdominal |