Bowel preparation or not in elective colon surgery

ISRCTN ISRCTN28535118
DOI https://doi.org/10.1186/ISRCTN28535118
Protocol serial number N/A
Sponsor Umea University/The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
Funder The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
Submission date
25/07/2005
Registration date
17/11/2005
Last edited
19/02/2008
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Erik Nilsson
Scientific

Kirurg Kliniken
Norrlands Universitetssjukhus
Umeå
90185
Sweden

erik.nilsson@surgery.umu.se

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Scientific title
Study acronymBoniec
Study objectivesPostoperative complication rate in the bowel preparation group is the same as in the non-bowel preparation group (null hypothesis).
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedElective colon surgery
InterventionThe study compares colon surgery with preoperatively given bowel preparation (standard today) with no given bowel preparation preoperatively.
Intervention typeProcedure/Surgery
Primary outcome measure(s)

1. Mortality within 30 days postop
2. Local infectious complications
3. Cardiovascular complications

Key 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

Completion date11/03/2005

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target sample size at registration1500
Key inclusion criteria1. 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
Key exclusion criteriaBowel preparation given preoperatively from other reasons than surgery.
Date of first enrolment01/01/1999
Date of final enrolment11/03/2005

Locations

Countries of recruitment

  • Sweden

Study participating centre

Kirurg Kliniken
Umeå
90185
Sweden

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/06/2007 Yes No
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