Long-term incidence of incisional hernia after abdominal surgery

ISRCTN	ISRCTN65599814
DOI	https://doi.org/10.1186/ISRCTN65599814
Secondary identifying numbers	N/A

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

Dr. H. van der Hoffplein 1
Sittard-Geleen
6130 MB
Netherlands

Email	t.hoofwijk@orbisconcern.nl

Study information

Study design	Prospective randomised clinical trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient 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	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 study start date	01/10/2001
Completion date	01/01/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	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

Sponsor information

Orbis Medical Centre (Netherlands)
Hospital/treatment centre

c/o Dr AGM Hoofwijk
Department of General Surgery
PO Box 5500
Sittard
6130 MB
Netherlands

Phone	+31 (0)88 459 77 77
Email	t.hoofwijk@orbisconcern.nl
Website	http://www.orbisconcern.nl/

Funders

Funder type

Hospital/treatment centre

Orbis Medical Centre (Netherlands)

No information available

Results and Publications

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

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011	18/12/2020	Yes	No

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.