Contact information
Type
Scientific
Primary contact
Dr AGM Hoofwijk
ORCID ID
Contact details
Dr. H. van der Hoffplein 1
Sittard-Geleen
6130 MB
Netherlands
t.hoofwijk@orbisconcern.nl
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Long-term incidence of incisional hernia after abdominal surgery: a prospective randomised trial comparing two suture materials
Acronym
Buiksluittrial (Belly Close Trial)
Study hypothesis
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
Local Medical Ethics Committee (Medisch Ethische Toetsingscommissie) approved in 2001 (ref: 01.005)
Study design
Prospective randomised clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
Incidence of incisional hernia, measured until 6 months (end of follow-up)
Secondary outcome measures
Measured until 6 months (end of follow-up):
1. Wound infection
2. Suture sinus
Overall trial start date
01/10/2001
Overall trial end date
01/01/2005
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant 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
Recruitment start date
01/10/2001
Recruitment end date
01/01/2005
Locations
Countries of recruitment
Netherlands
Trial participating centre
Dr. H. van der Hoffplein 1
Sittard-Geleen
6130 MB
Netherlands
Sponsor information
Organisation
Orbis Medical Centre (Netherlands)
Sponsor details
c/o Dr AGM Hoofwijk
Department of General Surgery
PO Box 5500
Sittard
6130 MB
Netherlands
+31 (0)88 459 77 77
t.hoofwijk@orbisconcern.nl
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Orbis Medical Centre (Netherlands)
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