Mesh Versus Suture Repair for Umbilical Hernias - Full Text View

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.

Condition	Intervention
Umbilical Hernia	Procedure: primary suture closure Device: mesh enforced closure


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Suture versus mesh repair in umbilical hernia patients Masking: Participant, Investigator, Outcomes Assessor Primary Purpose: Treatment
Official Title:	Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial

Resource links provided by NLM:

MedlinePlus related topics: Hernia

U.S. FDA Resources

Further study details as provided by Ruth Kaufmann, MD, Erasmus Medical Center:

Primary Outcome Measures:

hernia recurrence rate [ Time Frame: 24 months ]

Secondary Outcome Measures:

Post-operative morbidity and complications [ Time Frame: 3 months ]


Enrollment:	300
Study Start Date:	January 2006
Study Completion Date:	August 2015
Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00789230

Locations


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

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

More Information


Responsible Party:	Ruth Kaufmann, MD, R. Kaufmann, Erasmus Medical Center
ClinicalTrials.gov Identifier:	NCT00789230 History of Changes
Other Study ID Numbers:	HUMP
Study First Received:	November 9, 2008
Last Updated:	April 5, 2017
Individual Participant Data
Plan to Share IPD:	No


Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		Yes
Device Product Not Approved or Cleared by U.S. FDA:		No
Pediatric Postmarket Surveillance of a Device Product:		No

Keywords provided by Ruth Kaufmann, MD, Erasmus Medical Center:


umbilical hernia mesh

Additional relevant MeSH terms:


Hernia Hernia, Umbilical Pathological Conditions, Anatomical	Infant, Newborn, Diseases Hernia, Ventral Hernia, Abdominal

ClinicalTrials.gov processed this record on June 23, 2017

Mesh Versus Suture Repair for Umbilical Hernias (HUMP)