Condition category
Surgery
Date applied
25/07/2005
Date assigned
17/11/2005
Last edited
19/02/2008
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

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

  1. 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.

Additional files

Editorial Notes