Comparison of the postoperative rate of complications and infections in indwelling and suprapubic urinary catheters
| ISRCTN | ISRCTN46098701 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN46098701 |
| Secondary identifying numbers | 1 |
- Submission date
- 27/11/2008
- Registration date
- 16/01/2009
- Last edited
- 16/03/2011
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Urological and Genital Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr Ute Kringel
Scientific
Scientific
Department of Obstetrics and Gynaecology
University of Rostock
Suedring 81
Rostock
18059
Germany
| Phone | +49 381 4401 4700 |
|---|---|
| ute.kringel@uni-rostock.de |
Study information
| Study design | Randomised controlled single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Comparison of the postoperative rate of complications and infections in indwelling urinary catheters and suprapubic catheters after anterior colporrhaphia: a three-arm prospective randomised trial |
| Study objectives | Suprapubic (Arm C) and indwelling urinary catheters (IUCs) for 96 hours (Arm B) are preferred in Europe after operations, including anterior colporrhaphia. Hypothesis 1: If there is no difference in infection or complication rate between IUCs for 96 hours (Arm B) and IUCs for 24 hours (Arm A), the latter will be considered sufficient. Hypothesis 2: If IUCs for 24 hours (Arm A) have no higher rate of infections and complications compared to suprapubic catheter for 96 hours (Arm C), the former could be considered sufficient. |
| Ethics approval(s) | Ethics Committee of the Medical Faculty, Institute of Forensic Medicine, University of Rostock, approved on 02/02/2007 (ref: HV 03/2007) |
| Health condition(s) or problem(s) studied | Urinary tract infection after operation |
| Intervention | Method of randomisation: permutated block randomisation with variable block length Duration of recruitment: 12 months Arm A: IUCs for 24 hours Arm B: IUCs for 96 hours Arm C: suprapubic catheter for 96 hours In Arm A and B the indwelling catheter was installed under sterile conditions preoperatively by a scrub nurse. In Arm C the catheter was inserted under sterile conditions directly after theatre by the performing surgeon. Total duration of follow-up: until discharge (mean value: 6.85 days +/- 1.45). |
| Intervention type | Other |
| Primary outcome measure | Rate of urinary tract infection at 4 days after operation. |
| Secondary outcome measures | Complications, assessed on the day of discharge (mean value: 6.85 days +/- 1.45). |
| Overall study start date | 01/03/2007 |
| Completion date | 29/02/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 300 |
| Key inclusion criteria | 1. Female patients 2. 45-85 year old 3. Patients with a planned anterior colporrhaphia 4. Patient's consent 5. Urine analysis and urine culture immediately before and 4 days after the operation |
| Key exclusion criteria | 1. Symptomatic urinary tract infection preoperatively 2. Epidural anaesthesia |
| Date of first enrolment | 01/03/2007 |
| Date of final enrolment | 29/02/2008 |
Locations
Countries of recruitment
- Germany
Study participating centre
Department of Obstetrics and Gynaecology
Rostock
18059
Germany
18059
Germany
Sponsor information
University of Rostock (Germany)
University/education
University/education
Medical Faculty
Department of Obstetrics and Gynaecology
Suedring 81
Rostock
18059
Germany
| Phone | +49 381 4401 4500 |
|---|---|
| bernd.gerber@med.uni-rostock.de | |
| Website | http://www.kliniksued-rostock.de/klinikum/ |
"ROR" |
https://ror.org/03zdwsf69 |
Funders
Funder type
University/education
University of Rostock (Germany)
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 | 01/12/2010 | Yes | No |
