Hernia Umbilicalis Mesh versus Primary suture

ISRCTN	ISRCTN12851811
DOI	https://doi.org/10.1186/ISRCTN12851811
Secondary identifying numbers	N/A

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr Johan Lange
Scientific

Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Email	j.lange@erasmusmc.nl

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Prevention
Scientific title	Hernia Umbilicalis Mesh versus Primary suture
Study acronym	HUMP
Study objectives	In the repair of small umbilical hernias, mesh should be used to prevent recurrence.
Ethics approval(s)	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).
Health condition(s) or problem(s) studied	Umbilical hernia
Intervention	Mesh or primary suture
Intervention type	Other
Primary outcome measure	Recurrence
Secondary outcome measures	Quality of life
Overall study start date	01/05/2006
Completion date	01/05/2008

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	300
Total final enrolment	300
Key inclusion criteria	Patients with a primary umbilical hernia
Key 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
Date of first enrolment	01/05/2006
Date of final enrolment	01/05/2008

Dr. Molewaterplein 40

Rotterdam
3015 GD
Netherlands

Erasmus Medical Center (The Netherlands)
Hospital/treatment centre

Dr Molewaterplein 40
Rotterdam
3015 GD
Netherlands

Hospital/treatment centre

Erasmus Medical Centre Rotterdam

No information available

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	03/03/2018	07/01/2021	Yes	No

07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.