Colorectal CancerNCT01186237
Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study
A study testing Early urinary catheter removal in people with Colorectal Cancer, run by Stanford University at 1 site in United States.
Trial summary
Recent national surgical quality guidelines (Surgical Care Improvement Project, National Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by post-operative day two for all surgical patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Cancer
- What is being tested?
- Early urinary catheter removal
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2010to Dec 2012
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients at Stanford Hospital undergoing:
- anterior resection
- sigmoid colectomy
- low anterior resection
- abdomino-perineal resection
- total proctocolectomy with ileal pouch-analanastomosis
- coloanalanastomosis.
- Exclusion criteria Patients with history of neurogenic bladder who had indwelling catheters or required intermittent straight catheterization prior to surgery
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Stanford University School of Medicine
Stanford, California, 94305
About this study
Recent national surgical quality guidelines (Surgical Care Improvement Project, National Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by post-operative day two for all surgical patients. These guidelines exclude neither patients who have undergone rectal surgery nor those with epidural analgesic catheters. The common practice among most colorectal surgeons is to leave urinary catheters in for three to five days for patients who have undergone rectal operations, due to concern for urinary retention. This study aims to explore the outcomes of following the national surgical guidelines for early urinary catheter removal, especially with regards to urinary retention and urinary tract infection.
Read the detailed description
All patients undergoing anterior resection (rectosigmoid), low anterior resection, abdomino-perineal resection, total proctocolectomy with ileal pouch-anal anastomosis, sigmoid colectomy, and coloanal anastomosis will be included in the study. All patients will undergo standard pre-operative work-up prior to the operation. As part of the operative note, the level of the anastomosis must be documented.
- All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
- All patients will undergo bladder ultrasound prior to catheter removal.
- All patients will undergo bladder ultrasound by nursing staff six hours after catheter removal, and after voiding the first time after catheter removal, or if the patient experiences symptoms of urinary retention.
- Patients who meet definition of urinary retention (>100cc post-void residual) will undergo intermittent straight catheterization every six hours or with symptoms. For those who refuse intermittent straight catheterization, a indwelling urinary catheter will be inserted and left in for 24 hours before removal.
- For patients who have low urine output indicating under-resuscitation, indwelling catheters will be re-inserted and removed when ongoing resuscitation measures are completed.
- For patients who are actively undergoing fluid resuscitation on post-operative day 3 will not have their urinary catheters removed until resuscitation and monitoring is complete.
- Patients who report symptoms of benign prostatic hypertrophy (BPH) and/or are already on medications for BPH will be continued on those medications starting on post-operative day 1.
- Patients who have persistent urinary retention when they are otherwise ready to be discharged home will be sent home with a leg bag and follow up in urology clinic for voiding trial in 1-2 weeks.
- Urinalysis/urine culture will be performed for symptomatic patients.
- Conditions
- Colorectal Cancer
- Being tested
- Early urinary catheter removal
- Keywords
- Colon/Rectal Cancer Rectal Cancer, Quality of Life
- Medical subject headings
- Colorectal Neoplasms, Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early urinary catheter removalProcedure or surgery
All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
| Study group | Role | What they receive |
|---|---|---|
| Early urinary catheter removal | Experimental | Not described Receives: Procedure: Early urinary catheter removal |
What is being measured
The primary outcome is the main question the study is designed to answer.
urinary retention
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2010 (estimated)
- Study startJun 2010
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Lane Welton, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01186237
- Sponsor's protocol ID
- REC0004
- Other IDs
- SU-05272010-6187, 17865, NCI-2010-02350
- Status last verified
- Mar 2021
- First submitted
- 9 Aug 2010
- Last updated
- 22 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study
- ClinicalTrials.gov ID
- NCT01186237
- Acronym / sponsor ID
- REC0004
- Conditions
- Colorectal Cancer
- Keywords
- Colon/Rectal Cancer Rectal Cancer, Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Study start
- Jun 2010 (actual)
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 23 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.
Recent national surgical quality guidelines (Surgical Care Improvement Project, National Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by post-operative day two for all surgical patients. These guidelines exclude neither patients who have undergone rectal surgery nor those with epidural analgesic catheters. The common practice among most colorectal surgeons is to leave urinary catheters in for three to five days for patients who have undergone rectal operations, due to concern for urinary retention. This study aims to explore the outcomes of following the national surgical guidelines for early urinary catheter removal, especially with regards to urinary retention and urinary tract infection.
Detailed description
All patients undergoing anterior resection (rectosigmoid), low anterior resection, abdomino-perineal resection, total proctocolectomy with ileal pouch-anal anastomosis, sigmoid colectomy, and coloanal anastomosis will be included in the study. All patients will undergo standard pre-operative work-up prior to the operation. As part of the operative note, the level of the anastomosis must be documented.
- All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).
- All patients will undergo bladder ultrasound prior to catheter removal.
- All patients will undergo bladder ultrasound by nursing staff six hours after catheter removal, and after voiding the first time after catheter removal, or if the patient experiences symptoms of urinary retention.
- Patients who meet definition of urinary retention (>100cc post-void residual) will undergo intermittent straight catheterization every six hours or with symptoms. For those who refuse intermittent straight catheterization, a indwelling urinary catheter will be inserted and left in for 24 hours before removal.
- For patients who have low urine output indicating under-resuscitation, indwelling catheters will be re-inserted and removed when ongoing resuscitation measures are completed.
- For patients who are actively undergoing fluid resuscitation on post-operative day 3 will not have their urinary catheters removed until resuscitation and monitoring is complete.
- Patients who report symptoms of benign prostatic hypertrophy (BPH) and/or are already on medications for BPH will be continued on those medications starting on post-operative day 1.
- Patients who have persistent urinary retention when they are otherwise ready to be discharged home will be sent home with a leg bag and follow up in urology clinic for voiding trial in 1-2 weeks.
- Urinalysis/urine culture will be performed for symptomatic patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early urinary catheter removal | Experimental | Procedure: Early urinary catheter removal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- anterior resection
- sigmoid colectomy
- low anterior resection
- abdomino-perineal resection
- total proctocolectomy with ileal pouch-analanastomosis
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Early urinary catheter removalAll patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation). | Procedure or surgery | Early urinary catheter removal |
Primary outcome
urinary retention
Time frame: 6 months
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 22 Mar 2021.
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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.
Mark Lane Welton principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Early urinary catheter removal in people with Colorectal Cancer, run by Stanford University at 1 site in United States.
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 8 inclusion and 0 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 22 Mar 2021. 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 United States. 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?
urinary retention (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2021.