Bowel preparation or not in elective colon surgery
| ISRCTN | ISRCTN28535118 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN28535118 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Kirurg Kliniken
Norrlands Universitetssjukhus
Umeå
90185
Sweden
| erik.nilsson@surgery.umu.se |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | |
| Study acronym | Boniec |
| Study objectives | Postoperative 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) studied | 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 |
| Primary outcome measure | 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 study start date | 01/01/1999 |
| Completion date | 11/03/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 1500 |
| Key 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 |
| Key exclusion criteria | Bowel preparation given preoperatively from other reasons than surgery. |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 11/03/2005 |
Locations
Countries of recruitment
- Sweden
Study participating centre
Kirurg Kliniken
Umeå
90185
Sweden
90185
Sweden
Sponsor information
Umea University/The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
Research council
Research council
Norrlands Universitetssjukhus
Umeå
90185
Sweden
| peter.naredi@surgery.umu.se | |
"ROR" |
https://ror.org/05kb8h459 |
Funders
Funder type
Research council
The Health Research Council of South-East of Sweden (FORSS Sydöstra sjukvårdsregionen) (Sweden)
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 | 01/06/2007 | Yes | No |
