HUMP: Mesh Versus Suture Repair for Umbilical Hernias
Study Details
Study Description
Brief 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 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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
Arms and Interventions
| 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
|
Outcome Measures
Primary Outcome Measures
- hernia recurrence rate [24 months]
Secondary Outcome Measures
- Post-operative morbidity and complications [3 months]
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Studienzentrum der Deutschen Gesellschaft für Chirurgie | Heidelberg | Germany | ||
| 2 | University of Witten/Herdecke | Witten | Germany | ||
| 3 | Multimedica | Milano | Italy | ||
| 4 | Erasmus University Medical Center | Rotterdam | Zuid Holland | Netherlands | 3015CN |
| 5 | Onze Lieve Vrouwe Gasthuis | Amsterdam | Netherlands | ||
| 6 | Wilhelmina Ziekenhuis | Assen | Netherlands | ||
| 7 | Reinier de Graaf Gasthuis | Delft | Netherlands | ||
| 8 | Havenziekenhuis | Rotterdam | Netherlands | ||
| 9 | Ikazia | Rotterdam | Netherlands | ||
| 10 | Maasstad Ziekenhuis | Rotterdam | Netherlands | ||
| 11 | Máxima Medisch Centrum | Veldhoven | Netherlands | ||
| 12 | Isala | Zwolle | Netherlands |
Sponsors and Collaborators
- Ruth Kaufmann, MD
Investigators
- Principal Investigator: J. Jeekel, MD, PhD, Erasmus Medical Center
- Principal Investigator: J.F. Lange, MD, PhD, Erasmus Medical Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HUMP