Long-term incidence of incisional hernia after abdominal surgery
| ISRCTN | ISRCTN65599814 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN65599814 |
| Protocol serial number | N/A |
| Sponsor | Orbis Medical Centre (Netherlands) |
| Funder | Orbis Medical Centre (Netherlands) |
- Submission date
- 13/07/2010
- Registration date
- 21/07/2010
- Last edited
- 18/12/2020
- 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 AGM Hoofwijk
Scientific
Scientific
Dr. H. van der Hoffplein 1
Sittard-Geleen
6130 MB
Netherlands
| t.hoofwijk@orbisconcern.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective randomised clinical trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Long-term incidence of incisional hernia after abdominal surgery: a prospective randomised trial comparing two suture materials |
| Study acronym | Buiksluittrial (Belly Close Trial) |
| Study objectives | Non-absorbable sutures (Prolene®) cause less incisional hernias than slow-absorbing suture materials (PDS®) while not causing more other complications such as suture sinus or wound infection. |
| Ethics approval(s) | Local Medical Ethics Committee (Medisch Ethische Toetsingscommissie) approved in 2001 (ref: 01.005) |
| Health condition(s) or problem(s) studied | Abdominal wall: incisional hernia |
| Intervention | Closure of the abdominal fascia with non absorbable (Prolene®) or slow-absorbable (PDS®) suture-materials. All patients were followed up by outpatient visits after 1 month and 6 month intervals during which they were interviewed, examined and during which ultrasonography of the abdominal wall was performed. |
| Intervention type | Other |
| Primary outcome measure(s) |
Incidence of incisional hernia, measured until 6 months (end of follow-up) |
| Key secondary outcome measure(s) |
Measured until 6 months (end of follow-up): |
| Completion date | 01/01/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 600 |
| Total final enrolment | 223 |
| Key inclusion criteria | 1. Aged 18 - 86 years, either sex 2. Undergoing an elective or emergency median laparotomy at the General Surgery Department of the Orbis Medical Centre in the Netherlands |
| Key exclusion criteria | 1. Pregnancy 2. Presence of an abdominal hernia 3. No informed consent 4. Aged younger than 18 years 5. Life expectancy of less than 1 year |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Dr. H. van der Hoffplein 1
Sittard-Geleen
6130 MB
Netherlands
6130 MB
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 | 01/05/2011 | 18/12/2020 | Yes | No |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
18/12/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
