|
ISRCTN
|
ISRCTN28535118
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Bowel preparation or not in elective colon surgery
|
|
Scientific title
|
|
|
Acronym
|
Boniec
|
|
Serial number at source
|
N/A
|
|
Study hypothesis
|
Postoperative complication rate in the bowel preparation group is the same as in the non-bowel preparation group (null hypothesis).
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
Sweden
|
|
Disease/condition/study domain
|
Elective colon surgery
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Bowel preparation given preoperatively from other reasons than surgery.
|
|
Anticipated start date
|
01/01/1999
|
|
Anticipated end date
|
11/03/2005
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
1500
|
|
Interventions
|
The study compares colon surgery with preoperatively given bowel preparation (standard today) with no given bowel preparation preoperatively.
|
|
Primary outcome measure(s)
|
1. Mortality within 30 days postop
2. Local infectious complications
3. Cardiovascular complications
|
|
Secondary outcome measure(s)
|
1. Postop bleeding
2. Reoperation
3. General infectious complications
4. Length of postop hospital stay
5. Rehospitalisation within 30 days postop
|
|
Sources of funding
|
The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
|
|
Trial website
|
|
|
Publications
|
Results in http://www.ncbi.nlm.nih.gov/pubmed/17514668
|
|
Contact name
|
Prof
Erik
Nilsson
|
|
Address
|
Kirurg Kliniken
Norrlands Universitetssjukhus
|
|
City/town
|
Umeå
|
|
Zip/Postcode
|
90185
|
|
Country
|
Sweden
|
|
Email
|
erik.nilsson@surgery.umu.se
|
|
Sponsor
|
Umea University/The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
|
|
Address
|
Norrlands Universitetssjukhus
|
|
City/town
|
Umeå
|
|
Zip/Postcode
|
90185
|
|
Country
|
Sweden
|
|
Email
|
peter.naredi@surgery.umu.se
|
|
Date applied
|
25/07/2005
|
|
Last edited
|
19/02/2008
|
|
Date ISRCTN assigned
|
17/11/2005
|
