Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

Tracking Information
First Submitted Date ICMJE	November 9, 2008
First Posted Date ICMJE	November 11, 2008
Last Update Posted Date	February 26, 2018
Study Start Date ICMJE	January 2006
Actual Primary Completion Date	April 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures ICMJE; (submitted: November 9, 2008)	hernia recurrence rate [ Time Frame: 24 months ]
Original Primary Outcome Measures ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00789230 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ICMJE; (submitted: November 9, 2008)	Post-operative morbidity and complications [ Time Frame: 3 months ]
Original Secondary Outcome Measures ICMJE	Same as current
Current Other Outcome Measures ICMJE	Not Provided
Original Other Outcome Measures ICMJE	Not Provided
Descriptive Information
Brief Title ICMJE	Mesh Versus Suture Repair for Umbilical Hernias
Official Title ICMJE	Mesh Versus Suture Repair for Umbilical Hernias: a Double Blinded, Randomised Controlled Clinical Trial
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.
Study Type ICMJE	Interventional
Study Phase	Not Applicable
Study Design ICMJE	Allocation: Randomized; Intervention Model: Parallel Assignment; Intervention Model Description: Suture versus mesh repair in umbilical hernia patients Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
Condition ICMJE	Umbilical Hernia
Intervention ICMJE	Procedure: primary suture closure primary suture closure of hernia; Device: mesh enforced closure mesh enforced closure of hernia
Study Arms	Active Comparator: primary suture Intervention: Procedure: primary suture closure; Active Comparator: mesh enforced closure Intervention: Device: mesh enforced closure
Publications *	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.
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status ICMJE	Completed
Actual Enrollment ICMJE; (submitted: November 9, 2008)	300
Original Estimated Enrollment ICMJE	Same as current
Actual Study Completion Date	August 2015
Actual Primary Completion Date	April 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria ICMJE	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years and older (Adult, Senior)
Accepts Healthy Volunteers	No
Contacts ICMJE	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries ICMJE	Germany, Italy, Netherlands
Removed Location Countries
Administrative Information
NCT Number ICMJE	NCT00789230
Other Study ID Numbers ICMJE	HUMP
Has Data Monitoring Committee	Yes
U.S. FDA-regulated Product	Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement	Plan to Share IPD: No
Responsible Party	Ruth Kaufmann, MD, Erasmus Medical Center
Study Sponsor ICMJE	Ruth Kaufmann, MD
Collaborators ICMJE	Not Provided
Investigators ICMJE	Principal Investigator: J. Jeekel, MD, PhD Erasmus Medical Center Principal Investigator: J.F. Lange, MD, PhD Erasmus Medical Center
PRS Account	Erasmus Medical Center
Verification Date	February 2018
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP