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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00789230
Other study ID # HUMP
Secondary ID
Status Completed
Phase N/A
First received November 9, 2008
Last updated February 22, 2018
Start date January 2006
Est. completion date August 2015

Study information

Verified date February 2018
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date August 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Procedure:
primary suture closure
primary suture closure of hernia
Device:
mesh enforced closure
mesh enforced closure of hernia

Locations

Country Name City State
Germany Studienzentrum der Deutschen Gesellschaft für Chirurgie Heidelberg
Germany University of Witten/Herdecke Witten
Italy Multimedica Milano
Netherlands Onze Lieve Vrouwe Gasthuis Amsterdam
Netherlands Wilhelmina Ziekenhuis Assen
Netherlands Reinier de Graaf Gasthuis Delft
Netherlands Erasmus University Medical Center Rotterdam Zuid Holland
Netherlands Havenziekenhuis Rotterdam
Netherlands Ikazia Rotterdam
Netherlands Maasstad Ziekenhuis Rotterdam
Netherlands Máxima Medisch Centrum Veldhoven
Netherlands Isala Zwolle

Sponsors (1)

Lead Sponsor Collaborator
Ruth Kaufmann, MD

Countries where clinical trial is conducted

Germany,  Italy,  Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary hernia recurrence rate 24 months
Secondary Post-operative morbidity and complications 3 months
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