Hernia Umbilicalis Mesh versus Primary suture
| ISRCTN | ISRCTN12851811 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12851811 |
| Protocol serial number | N/A |
| Sponsor | Erasmus Medical Center (The Netherlands) |
| Funder | Erasmus Medical Centre Rotterdam |
- Submission date
- 20/04/2006
- Registration date
- 17/08/2006
- Last edited
- 07/01/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Johan Lange
Scientific
Scientific
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
| j.lange@erasmusmc.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Recurrence |
| Key secondary outcome measure(s) |
Quality of life |
| Completion date | 01/05/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dr. Molewaterplein 40
Rotterdam
3015 GD
Netherlands
3015 GD
Netherlands
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 03/03/2018 | 07/01/2021 | Yes | No |
Editorial Notes
07/01/2021: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
