Condition category
Digestive System
Date applied
13/07/2010
Date assigned
21/07/2010
Last edited
21/07/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.orbisconcern.nl/

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

Publication citations

Additional files

Editorial Notes