Clinical trial NCT00789230: Mesh Versus Suture Repair for Umbilical Hernias
Official title: Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Umbilical Hernia
Keywords: umbilical
hernia
mesh
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2008-11-11
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Suture versus mesh repair in umbilical hernia patients
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: hernia recurrence rate
timeFrame: 24 months
Secondary outcomes:
measure: Post-operative morbidity and complications
timeFrame: 3 months
Other outcomes:
Locations:
city: Heidelberg
country: Germany
facility: Studienzentrum der Deutschen Gesellschaft für Chirurgie
city: Witten
country: Germany
facility: University of Witten/Herdecke
city: Milano
country: Italy
facility: Multimedica
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
state: Zuid Holland
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Assen
country: Netherlands
facility: Wilhelmina Ziekenhuis
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
city: Rotterdam
country: Netherlands
facility: Havenziekenhuis
city: Rotterdam
country: Netherlands
facility: Ikazia
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
city: Veldhoven
country: Netherlands
facility: Máxima Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala
Study officials:
affiliation: Erasmus Medical Center
name: J. Jeekel, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: J.F. Lange, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.