HysterectomyNCT01182714
A Prospective Randomized Control Trial Comparing Immediate and 24-hours Delayed Catheter Removal Following Hysterectomy
A study testing immediate removal of in-dwelling catheter and 24 hours delayed removal of catheter in people with Hysterectomy, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In Hong Kong, it was the most common gynaecological open procedure done and the number of hysterectomies performed increased by almost 50% in 2004 when compared to 1999. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Hysterectomy
- What is being tested?
- immediate removal of in-dwelling catheter and 24 hours delayed removal of catheter
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2007to Sep 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- All women required total abdominal hysterectomy +/- bilateral salpingo-oophorectomy for various benign gynaecological diseases in Queen Mary Hospital
Who cannot join
- a known history of neurological disorder
- a known history of urinary incontinence
- women who had recurrent urinary tract infections or positive urine culture (>105 colony-forming units of an identified single uro-pathogen per milliliter of urine) pre-operatively
- women for whom a complicated procedure was encountered during the hysterectomy in which case in-dwelling catheter had to be kept post-operatively at the surgeon's decision
- women who had spinal anaesthesia as the choice of anaesthesia or received patient-controlled analgesia as post-operative pain relief.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Randomized Trial to Compare Immediate and 24-hours Delayed Catheter Removal Following Total Abdominal Hysterectomy
Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In Hong Kong, it was the most common gynaecological open procedure done and the number of hysterectomies performed increased by almost 50% in 2004 when compared to 1999. In-dwelling catheter use after uncomplicated abdominal hysterectomy has been the standard method for bladder treatment after the operation. It is traditionally advocated to assess urinary output and to prevent post-operative urinary retention as patients with abdominal wound are unable to increase the intra-abdominal pressure to aid voiding. However, in-dwelling catheters have been associated with increased white cell counts and higher rates of positive urine cultures, and subsequently urinary tract infection can lead to increased morbidity, duration of hospital stay, and overall healthcare cost.
Duration of catheter use post-operatively is generally based on custom rather than evidence-based knowledge and therefore varies considerably. The current practice of the investigators hospital is to leave an in-dwelling catheter in-situ for 24 hours after an uncomplicated open gynaecological surgery. Schiotz et al showed that twenty-four-hour catheterization after common gynaecological procedures was associated with a low rate of voiding problems after catheter removal. Post-operative urinary retention leading to bladder atony may increase the long-term morbidity through increased risk of infection, detrusor instability and voiding difficulties. In-dwelling catheter in the immediate post-operative period will help to combat this problem. However, this has to be balanced against the potential risk of catheter-associated urinary tract infection which varies from 5% to 43% in the published trials.
A prospective randomized study comparing immediate versus delayed catheter removal following hysterectomy showed that delayed removal after operation was not associated with an increased rate of febrile events or urinary tract infections, but a significantly higher subjective pain assessment. The size of the catheter used was 16F which was not the standard 12F that the investigators used in the investigators hospital setting. It is postulated that if a smaller caliber in-dwelling catheter is used, it will not result in an increased subjective pain assessment, and the catheter can be left in-situ for 24 hours without causing increased adverse outcomes but possibly reducing recatheterisation rate post-operatively.
- Conditions
- Hysterectomy
- Being tested
- immediate removal of in-dwelling catheter, 24 hours delayed removal of catheter
- Keywords
- Hysterectomy, Catheterisation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate removal of in-dwelling catheterProcedure or surgery
24 hours delayed removal of catheterProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| removal of catheter | Other | Not described Receives: Procedure: immediate removal of in-dwelling catheter; Procedure: 24 hours delayed removal of catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
the subjective pain assessment provided by the patient post-operatively
pain assessment using visual analogue scale
Measured: post operatively day 1
Secondary outcomes (2)
the rate of recatheterisation
Measured: at 6 hours post-operatively
incidence of symptomatic urinary tract infection
Measured: up to 7 days after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2010 (estimated)
- Study startNov 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HysterectomyStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Investigators
- Joyce Chai, MBChB, Principal investigator, Queen Mary Hospital, University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01182714
- Sponsor's protocol ID
- Foley-01
- Status last verified
- Aug 2010
- First submitted
- 11 Aug 2010
- Last updated
- 20 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
PubMed 34184246
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Trial to Compare Immediate and 24-hours Delayed Catheter Removal Following Total Abdominal Hysterectomy
- ClinicalTrials.gov ID
- NCT01182714
- Acronym / sponsor ID
- Foley-01
- Conditions
- Hysterectomy
- Keywords
- Hysterectomy, Catheterisation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Nov 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 17 Aug 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Total abdominal hysterectomy is a common gynaecological operation performed worldwide. In Hong Kong, it was the most common gynaecological open procedure done and the number of hysterectomies performed increased by almost 50% in 2004 when compared to 1999. In-dwelling catheter use after uncomplicated abdominal hysterectomy has been the standard method for bladder treatment after the operation. It is traditionally advocated to assess urinary output and to prevent post-operative urinary retention as patients with abdominal wound are unable to increase the intra-abdominal pressure to aid voiding. However, in-dwelling catheters have been associated with increased white cell counts and higher rates of positive urine cultures, and subsequently urinary tract infection can lead to increased morbidity, duration of hospital stay, and overall healthcare cost.
Duration of catheter use post-operatively is generally based on custom rather than evidence-based knowledge and therefore varies considerably. The current practice of the investigators hospital is to leave an in-dwelling catheter in-situ for 24 hours after an uncomplicated open gynaecological surgery. Schiotz et al showed that twenty-four-hour catheterization after common gynaecological procedures was associated with a low rate of voiding problems after catheter removal. Post-operative urinary retention leading to bladder atony may increase the long-term morbidity through increased risk of infection, detrusor instability and voiding difficulties. In-dwelling catheter in the immediate post-operative period will help to combat this problem. However, this has to be balanced against the potential risk of catheter-associated urinary tract infection which varies from 5% to 43% in the published trials.
A prospective randomized study comparing immediate versus delayed catheter removal following hysterectomy showed that delayed removal after operation was not associated with an increased rate of febrile events or urinary tract infections, but a significantly higher subjective pain assessment. The size of the catheter used was 16F which was not the standard 12F that the investigators used in the investigators hospital setting. It is postulated that if a smaller caliber in-dwelling catheter is used, it will not result in an increased subjective pain assessment, and the catheter can be left in-situ for 24 hours without causing increased adverse outcomes but possibly reducing recatheterisation rate post-operatively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| removal of catheter | Other | Procedure: immediate removal of in-dwelling catheter, Procedure: 24 hours delayed removal of catheter |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All women required total abdominal hysterectomy +/- bilateral salpingo-oophorectomy for various benign gynaecological diseases in Queen Mary Hospital
Key exclusion criteria (5 listed)
- a known history of neurological disorder
- a known history of urinary incontinence
- women who had recurrent urinary tract infections or positive urine culture (>105 colony-forming units of an identified single uro-pathogen per milliliter of urine) pre-operatively
- women for whom a complicated procedure was encountered during the hysterectomy in which case in-dwelling catheter had to be kept post-operatively at the surgeon's decision
- women who had spinal anaesthesia as the choice of anaesthesia or received patient-controlled analgesia as post-operative pain relief.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate removal of in-dwelling catheter | Procedure or surgery | removal of catheter |
| 24 hours delayed removal of catheter | Procedure or surgery | removal of catheter |
Primary outcome
the subjective pain assessment provided by the patient post-operatively
Time frame: post operatively day 1
pain assessment using visual analogue scale
2 secondary outcomes
the rate of recatheterisation
Time frame: at 6 hours post-operatively
incidence of symptomatic urinary tract infection
Time frame: up to 7 days after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2010.
- Derived from this study: PubMed 34184246Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joyce Chai, MBChB principal investigator
Queen Mary Hospital, University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate removal of in-dwelling catheter and 24 hours delayed removal of catheter in people with Hysterectomy, run by The University of Hong Kong at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the subjective pain assessment provided by the patient post-operatively (time frame: post operatively day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01182714, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Aug 2010.