Condition category
Digestive System
Date applied
20/04/2006
Date assigned
17/08/2006
Last edited
17/08/2006
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Johan Lange

ORCID ID

Contact details

Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
j.lange@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

HUMP

Study hypothesis

In the repair of small umbilical hernias, mesh should be used to prevent recurrence.

Ethics approval

Approved by the Medical Ethics Committee of Erasmus Medical Centre (Medisch Ethische Toetsings Commissie Erasmus M) on 13/04/2005 (reference number: MEC-2005-043).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Prevention

Patient information sheet

Condition

Umbilical hernia

Intervention

Mesh or primary suture

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Recurrence

Secondary outcome measures

Quality of live

Overall trial start date

01/05/2006

Overall trial end date

01/05/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients with a primary umbilical hernia

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

300

Participant exclusion criteria

1. Aged under 18 years
2. Peritoneal dialysis
3. Liver cirrhosis
4. Recurrence
5. Acute strangulation
6. American Society of Anesthesiologists (ASA) score more than III
7. Midline laparotomy in history

Recruitment start date

01/05/2006

Recruitment end date

01/05/2008

Locations

Countries of recruitment

Netherlands

Trial participating centre

Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Sponsor information

Organisation

Erasmus Medical Center (The Netherlands)

Sponsor details

Dr Molewaterplein 40
Rotterdam
3015 GD
Netherlands
+31 (0) 10 463 9222
j.lange@erasmusmc.nl

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Erasmus Medical Centre Rotterdam

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes