Mesh Versus Suture Repair for Umbilical Hernias | NCT00789230

Studies
Mesh Versus Suture Repair for Umbilical Hernias

NCT00789230

Sponsor

Ruth Kaufmann, MD

Status

Completed

Last Update Posted

Feb 26, 2018Actual

Enrollment

300Actual

Phase

Not Applicable

Conditions

Umbilical Hernia

Interventions

primary suture closure
mesh enforced closure

Countries

Germany
Italy
Netherlands

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2006

Primary Completion Date

Apr 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Nov 9, 2008

First Submission Date that Met QC Criteria

Nov 9, 2008

First Posted Date

Nov 11, 2008Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2018

Last Update Posted Date

Feb 26, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Ruth Kaufmann, MD, R. Kaufmann, Erasmus Medical CenterSponsor-Investigator

Lead Sponsor

Ruth Kaufmann, MDOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
primary suture	Active Comparator		Procedure: primary suture closure
mesh enforced closure	Active Comparator		Device: mesh enforced closure

Interventions

Name	Type	Description	Arm Group Labels	Other Names
primary suture closure	Procedure	primary suture closure of hernia	primary suture

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
hernia recurrence rate		24 months

Secondary Outcomes

Measure	Description	Time Frame
Post-operative morbidity and complications		3 months

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
J. Jeekel, MD, PhD	Erasmus Medical Center	Principal Investigator
J.F. Lange, MD, PhD	Erasmus Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Studienzentrum der Deutschen Gesellschaft für Chirurgie		Heidelberg			Germany
University of Witten/Herdecke

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
29459021	Derived	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.

Type	Date	Date Unknown
Release	Aug 4, 2018
Reset	Jan 22, 2019

ID	Term
D006554	Hernia, Umbilical
D006547	Hernia

ID	Term
D007232	Infant, Newborn, Diseases
D009358	Congenital, Hereditary, and Neonatal Diseases and Abnormalities
D006555	Hernia, Ventral
D046449	Hernia, Abdominal