Primary objective: to study potential risk factors for post-operative urinary retentionsecundary objective: construction of a risk calculator to identify patients at risk for post-operative urinary retention
ID
Source
Brief title
Condition
- Other condition
- Bladder and bladder neck disorders (excl calculi)
Synonym
Health condition
postoperatieve complicaties
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The occurrence of urinary retention (defined as the inability to void) either
within 7 days following the operation or within 7 days following the removal of
a planned postoperative indwelling catheter.
Secondary outcome
Postvoid residual of >250ml either within 24 hours following the operation or
within 24 hours following the removal of a planned postoperative indwelling
catheter.
Background summary
Postoperative urinary retention (POUR) is a frequently occurring complication.
The incidence varies between different types of surgery. The incidence
following orthopaedic procedures is high and varies from 11% to 84%. The wide
range reflects different definitions of POUR. Besides the type of surgery,
several studies showed that male sex, higher age, the presence of benign
prostatic hyperplasia, method of anaesthesia, amount of fluid administered
during the procedure, the use of certain opioids and the use of psychiatric
medication may increase the POUR risk.
A number of studies have found predictive factors for POUR. These studies are
mostly retrospective and of poor quality; the results are often contradictory.
The urodynamic status of these patients has hardly been studied. And finally,
in a number of studies the followup was curiously enough limited to the
recovery room.
POUR leads to a dilated bladder, a higher risk of urinary tract infection and
prolonged hospital stay.
If it is possible to develop a risk calculator for POUR with the data of this
study, we can better identify patients who are at risk to develop POUR.
Subsequently, we could study interventions to lower the incidence of POUR.
Preventive measures like alfa-receptor blockers, temporarily stopping of risk
medication or catheterisation have not been studied yet.
Study objective
Primary objective: to study potential risk factors for post-operative urinary
retention
secundary objective: construction of a risk calculator to identify patients at
risk for post-operative urinary retention
Study design
prospective explorative study
Study burden and risks
burden
- completion of a questionnaire once. Estimated time needed: 20 minutes
- single outpatient visit for uroflowmetry and measurement of post void
residual. Estimated time needed: 15 minutes (there will be no waiting time for
the outpatient visit as these patients will be seen apart from the daily
clinics). Both measurements are completely painless and harmless.
- measurement of the bladdervolume by ultrasound just before the operation.
This measurement is completely painless and harmless. The measurement takes
about 1 minute and can be done either in bed or on the operation table.
risks: not applicable
All measurements of the postoperative bladder volume / post void residual will
be done according to the standard recovery-room and hospital protocol with the
bladderscan.
Spaarnepoort 1 Spaarnepoort 1
Hoofddorp 2134 TM
NL
Spaarnepoort 1 Spaarnepoort 1
Hoofddorp 2134 TM
NL
Listed location countries
Age
Inclusion criteria
Age > 20
One of the following planned surgeries (with known high-risk of POUR): all surgery with spinal anesthesia, all orthopedic surgery, all abdominal surgery, all surgery on hernia inguinalis, all neurological surgery, all vascular surgery and all surgery on hemorrhoids.
The patient understands the given information about the study
The patient signed the informed consent form
Exclusion criteria
Planned lower urinary tract or vaginal surgery
Recent (<3 months) operation on lower urinary tract of vaginal surgery
Indwelling catheter or intermittent catheterization before surgery
Catheter planned within 5 days after surgery
Cystectomy
Spinal cord lesion
Catheterisation during surgery (standard) is no exclusion criterium
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL51214.094.14 |