Mesh Versus Suture Repair for Umbilical Hernias (HUMP)

• ClinicalTrials.gov Identifier: NCT00789230
• Recruitment Status: Completed
• First Posted: November 11, 2008
• Last Update Posted: February 26, 2018
• Sponsor: Ruth Kaufmann, MD
• Information provided by (Responsible Party): Ruth Kaufmann, MD, Erasmus Medical Center

Tracking Information

• First Submitted Date: November 9, 2008
• First Posted Date: November 11, 2008
• Last Update Posted Date: February 26, 2018
• Study Start Date: January 2006
• Actual Primary Completion Date: April 2015 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 9, 2008): hernia recurrence rate [ Time Frame: 24 months ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: November 9, 2008): Post-operative morbidity and complications [ Time Frame: 3 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Mesh Versus Suture Repair for Umbilical Hernias
• Official Title: 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: Interventional
• Study Phase: Not Applicable

Study Design

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: Umbilical Hernia

Intervention

• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2008): 300
• Original Estimated Enrollment: 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

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, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany, Italy, Netherlands

Administrative Information

• NCT Number: NCT00789230
• Other Study ID Numbers: 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

• Current Responsible Party: Ruth Kaufmann, MD, Erasmus Medical Center
• Original Responsible Party: Professor Dr. J. Jeekel, ErasmusMedical Center Rotterdam
• Current Study Sponsor: Ruth Kaufmann, MD
• Original Study Sponsor: Erasmus Medical Center
• Collaborators: Not Provided

Investigators

• 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