Mesh Versus Suture Repair for Umbilical Hernias

Umbilical Hernia Clinical Trial

— HUMP  

Official title:

Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00789230
• Other study ID #: HUMP
• 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
• 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

Related Conditions & MeSH terms

• Hernia
• Hernia, Umbilical
• Umbilical Hernia

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