Contact information
Type
Scientific
Primary contact
Prof Erik Nilsson
ORCID ID
Contact details
Kirurg Kliniken
Norrlands Universitetssjukhus
Umeå
90185
Sweden
erik.nilsson@surgery.umu.se
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Boniec
Study hypothesis
Postoperative complication rate in the bowel preparation group is the same as in the non-bowel preparation group (null hypothesis).
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Elective colon surgery
Intervention
The study compares colon surgery with preoperatively given bowel preparation (standard today) with no given bowel preparation preoperatively.
Intervention type
Procedure/Surgery
Phase
Not Specified
Drug names
Primary outcome measures
1. Mortality within 30 days postop
2. Local infectious complications
3. Cardiovascular complications
Secondary outcome measures
1. Postop bleeding
2. Reoperation
3. General infectious complications
4. Length of postop hospital stay
5. Rehospitalisation within 30 days postop
Overall trial start date
01/01/1999
Overall trial end date
11/03/2005
Reason abandoned
Eligibility
Participant inclusion criteria
1. Patient aged 18 - 85 years
2. Elective resection for cancer, adenoma or diverticular disease
3. Survival over 6 months foreseen
4. Written consent after written and spoken information
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
1500
Participant exclusion criteria
Bowel preparation given preoperatively from other reasons than surgery.
Recruitment start date
01/01/1999
Recruitment end date
11/03/2005
Locations
Countries of recruitment
Sweden
Trial participating centre
Kirurg Kliniken
Umeå
90185
Sweden
Sponsor information
Organisation
Umea University/The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
Sponsor details
Norrlands Universitetssjukhus
Umeå
90185
Sweden
peter.naredi@surgery.umu.se
Sponsor type
Research council
Website
Funders
Funder type
Research council
Funder name
The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/17514668
Publication citations
-
Results
Jung B, Påhlman L, Nyström PO, Nilsson E, , Multicentre randomized clinical trial of mechanical bowel preparation in elective colonic resection., Br J Surg, 2007, 94, 6, 689-695, doi: 10.1002/bjs.5816.