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ISRCTN
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ISRCTN65599814
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ClinicalTrials.gov identifier
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Public title
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Long-term incidence of incisional hernia after abdominal surgery
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Scientific title
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Long-term incidence of incisional hernia after abdominal surgery: a prospective randomised trial comparing two suture materials
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Acronym
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Buiksluittrial (Belly Close Trial)
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Serial number at source
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N/A
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Study hypothesis
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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.
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Lay summary
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Ethics approval
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Local Medical Ethics Committee (Medisch Ethische Toetsingscommissie) approved in 2001 (ref: 01.005)
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Study design
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Prospective randomised clinical trial
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Countries of recruitment
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Netherlands
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Disease/condition/study domain
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Abdominal wall: incisional hernia
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Participants - inclusion criteria
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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
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Participants - exclusion criteria
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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
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Anticipated start date
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01/10/2001
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Anticipated end date
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01/01/2005
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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600
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Interventions
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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.
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Primary outcome measure(s)
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Incidence of incisional hernia, measured until 6 months (end of follow-up)
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Secondary outcome measure(s)
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Measured until 6 months (end of follow-up):
1. Wound infection
2. Suture sinus
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Sources of funding
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Orbis Medical Centre (Netherlands)
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Trial website
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Publications
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Contact name
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Dr
AGM
Hoofwijk
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Address
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Dr. H. van der Hoffplein 1
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City/town
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Sittard-Geleen
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Zip/Postcode
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6130 MB
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Country
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Netherlands
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Email
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t.hoofwijk@orbisconcern.nl
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Sponsor
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Orbis Medical Centre (Netherlands)
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Address
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c/o Dr AGM Hoofwijk
Department of General Surgery
PO Box 5500
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City/town
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Sittard
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Zip/Postcode
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6130 MB
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Country
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Netherlands
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Tel
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+31 (0)88 459 77 77
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Fax
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+31 (0)88 459 7970
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Email
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t.hoofwijk@orbisconcern.nl
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Sponsor website:
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http://www.orbisconcern.nl/
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Date applied
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13/07/2010
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Last edited
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21/07/2010
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Date ISRCTN assigned
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21/07/2010
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