Rectum CancerNCT03065855
Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum
A study testing Early removal group and Normal removal group in people with Rectum Cancer, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rectum Cancer
- What is being tested?
- Early removal group and Normal removal group
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 220 participants
- Where
- 1 siteChina
- Study dates
- Feb 2017to Aug 2017
- 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
- Competent to consent to participate in trial
- Patients with rectal cancer who underwent total or tumor-specific-mesorectal excision with colorectal or colonanal anastomosis
- Elective surgery
- ASA classification of 1~3
- If male, international prostate symptom score <20.
Who cannot join
- Combined pelvic surgery(pelvic lymph node dissection, hysterectomy, salpingo-oophorectomy, posterior vaginectomy, cystectomy, ureteral double-J stenting, ureterectomy, ureteroureterostomy, prostatectomy)
- Postoperative complications with a Dindo grade III or more
- Known urinary disease(end-stage renal disease, benign prostatic hyperplasia, neurogenic bladder, malignancy)
Trial locations and contacts
1 site in 1 country.
XU Lai contact
China1 site
Peking union medical college hospital
Beijing, Beijing Municipality, 100730
Xu Lai, drxulai@pumch.cn
About this study
Official title: Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.
Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum
Read the detailed description
For a better view to avoid accidental trauma and monitoring kidney function during surgery and in the post-surgery period, patients undergoing abdominal operations will usually have a urinary catheter placed in the bladder before the surgery. Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.
Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum
.
- Conditions
- Rectum Cancer
- Being tested
- Early removal group, Normal removal group
- Keywords
- laparoscopic mesorectal excision, rectal cancer, urinary distention
- Medical subject headings
- Rectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early removal groupProcedure or surgery
Participants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum.
Normal removal groupProcedure or surgery
Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution.
| Study group | Role | What they receive |
|---|---|---|
| Early removal group | Experimental | All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 2 days following surgery. Receives: Procedure: Early removal group |
| Normal removal group | Active comparator | All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution. Receives: Procedure: Normal removal group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative urinary retention requiring re-catheterisation
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period
Measured: 1 day following urethral catheter removal
Secondary outcomes (2)
Urinary tract infection
Before catheter removal, take a mid-stream urine sample for microscopy and culture. Leucocyte in urine ≥5/HP for man and ≥10/HP for woman is defined as bacteruria with urinary irritation or not.A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture.
Measured: Within 7 days of urethral catheter removal
Urethrorrhagia
take a mid-stream urine sample for Clinical urine tests and RBC≥3/HP is defined as urethrorrhagia.
Measured: Within 7 days of urethral catheter removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2017
- Study startFeb 2017 (estimated)
- Primary completionJul 2017 (estimated)
- Study completionAug 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Rectum CancerStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 220 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03065855
- Sponsor's protocol ID
- ARCTIC
- Status last verified
- Jan 2017
- First submitted
- 23 Feb 2017
- Last updated
- 28 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Other researchers have access to data in the form of published papers
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 34184246Xu L, Tao ZY, Lu JY, Zhang GN, Qiu HZ, Wu B, Lin GL, Xu T, Xiao Y. A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):133. doi: 10.1186/s13063-019-3210-1.
PubMed 30770766
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Amonocenter, Prospective, Randomized Clinical Trial to Investigate the Removal Time of Urinary Catheter After Laparoscopic Anterior Resection of the Rectum.
- ClinicalTrials.gov ID
- NCT03065855
- Acronym / sponsor ID
- ARCTIC
- Conditions
- Rectum Cancer
- Keywords
- laparoscopic mesorectal excision, rectal cancer, urinary distention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 220 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Feb 2017 (estimated)
- Primary completion
- Jul 2017 (estimated)
- Study completion
- Aug 2017 (estimated)
- First posted
- 28 Feb 2017 (actual)
- 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.
Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief，but there is no clear data on the incidence of urine retention.Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum
Detailed description
For a better view to avoid accidental trauma and monitoring kidney function during surgery and in the post-surgery period, patients undergoing abdominal operations will usually have a urinary catheter placed in the bladder before the surgery. Traditionally these catheters are retained for 7 days, because a higher incidence of urinary retention is related to early removal of the urinary catheter. However, recently Enhanced Recovery After Surgery presents that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief.
Longer retaining time of urethral catheter would induce the urinary tract infection while early removal of urethral catheter is considered to develop acute retention of urine due to lack of sensation when the bladder is full. Taking the comfort and mobility for faster rehabilitation of patients into account, the investigators aim at obtain the optimal removal time of urinary catheter after after laparoscopic anterior resection of the rectum
.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early removal group | Experimental | Procedure: Early removal groupAll participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 2 days following surgery. |
| Normal removal group | Active comparator | Procedure: Normal removal groupAll participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Competent to consent to participate in trial
- Patients with rectal cancer who underwent total or tumor-specific-mesorectal excision with colorectal or colonanal anastomosis
- Elective surgery
- ASA classification of 1~3
- If male, international prostate symptom score <20.
Key exclusion criteria (3 listed)
- Combined pelvic surgery(pelvic lymph node dissection, hysterectomy, salpingo-oophorectomy, posterior vaginectomy, cystectomy, ureteral double-J stenting, ureterectomy, ureteroureterostomy, prostatectomy)
- Postoperative complications with a Dindo grade III or more
- Known urinary disease(end-stage renal disease, benign prostatic hyperplasia, neurogenic bladder, malignancy)
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 removal groupParticipants assigned to the experimental arm will have their urethral catheters removed at 2 days after after laparoscopic anterior resection of the rectum. | Procedure or surgery | Early removal group |
| Normal removal groupParticipants assigned to the control group will have their urethral catheters removed at 7days following surgery, as is standard practice in our institution. | Procedure or surgery | Normal removal group |
Primary outcome
Post-operative urinary retention requiring re-catheterisation
Time frame: 1 day following urethral catheter removal
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 1 day of removal of urethral catheter in the post-operative period
2 secondary outcomes
Urinary tract infection
Time frame: Within 7 days of urethral catheter removal
Urethrorrhagia
Time frame: Within 7 days of urethral catheter removal
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2017.
- 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.
- Derived from this study: PubMed 30770766Xu L, Tao ZY, Lu JY, Zhang GN, Qiu HZ, Wu B, Lin GL, Xu T, Xiao Y. A single-center, prospective, randomized clinical trial to investigate the optimal removal time of the urinary catheter after laparoscopic anterior resection of the rectum: study protocol for a randomized controlled trial. Trials. 2019 Feb 15;20(1):133. doi: 10.1186/s13063-019-3210-1.
- Individual participant dataSharing planned: Yes. Other researchers have access to data in the form of published papers
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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.
XU Lai contact
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 removal group and Normal removal group in people with Rectum Cancer, run by Peking Union Medical College Hospital at 1 site in China.
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 5 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 28 Feb 2017. 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 China. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact XU Lai (drxulai@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Post-operative urinary retention requiring re-catheterisation (time frame: 1 day following urethral catheter removal). 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 NCT03065855, which also lists 2 linked publications.
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 28 Feb 2017.