- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06217016
Effect of ICCAUT Strategy on Postoperative Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)
April 20, 2024 updated by: Yuchen Guo, Ph.D., The First Hospital of Jilin University
Effect of Intermittent Urethral Catheter Clamping Combined With Active Urination Training (ICCAUT) Strategy on Postoperative Re-catheterization Secondary to Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)
The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy.
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy.
This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group.
In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal.
Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying.
While patients in the free-drainage group will not undergo any specific training.
The urinary catheter will be removed on the second postoperative day for both groups.
The primary endpoint is the incidence of re-catheterization due to urinary retention.
Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
Study Overview
Status
Suspended
Intervention / Treatment
Detailed Description
Urinary catheter placement is a standard procedure before proctectomy.
However, the necessity of bladder training prior to catheter removal remains uncertain.
The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy.
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy.
This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group.
In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal.
Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying.
While patients in the free-drainage group will not undergo any specific training.
The urinary catheter will be removed on the second postoperative day for both groups.
The primary endpoint is the incidence of re-catheterization due to urinary retention.
Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.
Study Type
Interventional
Enrollment (Estimated)
1686
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Yuchen Guo, Ph.D
- Phone Number: +8613630598312
- Email: guoyuchen8688@jlu.edu.cn
Study Locations
-
-
Jilin
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Chang chun, Jilin, China, 130021
- First Hospital of Jilin University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Patients with a confirmed preoperative diagnosis of rectal cancer.
- Patients with tumors located below the rectosigmoid junction, as determined by preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
- Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.
Exclusion Criteria:
- History of abdominal surgery involving the rectum, sigmoid colon, left hemicolectomy, bladder resection or partial resection, prostate surgery, or hysterectomy.
- History of urethral injury, cranial surgery, spinal surgery, stroke with limb dysfunction, or Parkinson's disease.
- Inability to urinate through the urethra preoperatively due to various reasons (e.g., ureteral puncture or ureterostomy).
- Presence of urinary tract infection preoperatively.
- Previously diagnosed with bladder overactivity syndrome, urinary retention or voiding dysfunction, or diabetic bladder disease.
- Concomitant resection of other pelvic organs was performed during surgery, including the bladder, prostate, uterus, cervix, and vagina, except for simple adnexal resection.
- Lateral lymph node dissection for rectal cancer.
- Injury to the ureter, bladder, or urethra during the perioperative period.
- Preoperative renal dysfunction (serum creatinine level >133 μmol/L).
- Emergency surgery.
- Male patients with preoperative benign prostatic hyperplasia receiving medication treatment.
- Patients with a ureteral stent or ureteral stricture, or bilateral hydronephrosis.
- Conversion to open surgery.
Withdrawal Criteria:
After randomization, patients will be withdrawn from the trial if the following situations occur:
- Inability to remove the urinary catheter within 5 days postoperatively due to various reasons (e.g., impaired consciousness, transfer to the intensive care unit (ICU), Sequential Organ Failure Assessment (SOFA) score ≥2, etc.).
- Secondary catheterization was performed after catheter removal for reasons other than urinary retention (e.g., secondary surgery, shock, rectal bladder leakage, ureteral leakage, or urethral injury).
- Patient requests to withdraw from the study at any time during the entire study process.
- Selective α1-adrenergic receptor blocker is used during the first catheterization of the patient due to medical necessity.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: ICCAUT Group
Patients undergoing laparoscopic/robotic rectal cancer TME surgery will undergo bladder training.
The bladder training include intermittent catheter clamping and active urination to facilitate complete bladder emptying each time the catheter is released, which we called ICCAUT strategy.
The training will commence at 9:00 am on the first postoperative day, and the catheter will be removed at 9:00 am on the second postoperative day.
|
In this study ,the ICCAUT strategy include intermittent catheter clamping and active urination training.
For patients in the ICCAUT group, intermittent catheter clamping will be initiated at 9:00 AM.
The catheter will be clamped for 3 h, followed by a 5-minute release, which is one cycle.
The next cycle will begin after the cycle was completed.
Catheter training is to conclude at 10:00 PM on the first postoperative day, and the catheter is left open during the night.
At 6:00 AM on the second postoperative day, another cycle of catheter training will be performed, with the catheter removed at 9:00 AM.
During the training period, if the patient experiences a strong urge to urinate before the 3-hour clamping time is over, the clamping can be released in advance for 5 min, allowing the patient to proceed to the next cycle of bladder training.
Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying.
|
Other: Free Drainage Group
Patients undergoing laparoscopic/robotic rectal cancer TME surgery will have their urinary catheter kept open postoperatively, and the catheter will be removed at 9:00 am on the second postoperative day.
|
For patients in the free draining group, no intervention will be performed on the catheter during this period.
The catheter will be removed at 9:00 AM on postoperative day two.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
secondary catheterization owing to urinary retention
Time Frame: within 7 days after the first time of urethral catheter removal
|
The primary endpoint of this study is the rate of secondary catheterization owing to urinary retention until discharge.
Secondary catheterization can be performed by urethral catheter insertion or suprapubic puncture.
The decision to perform secondary catheterization is based on the specific criteria determined by the clinician.
|
within 7 days after the first time of urethral catheter removal
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Urinary tract infections
Time Frame: within 1 days after the first time of urethral catheter removal
|
A urinary tract infection is characterized by an inflammatory response in the urinary tract epithelium resulting from bacterial invasion.
To diagnose a urinary tract infection, the following criteria must be met simultaneously: 1) urinalysis indicating a bacterial count above the upper limit of normal and 2) positive urine culture.
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within 1 days after the first time of urethral catheter removal
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The time to first voiding after catheter removal
Time Frame: within 1 days after the first time of urethral catheter removal
|
The time to first voiding after catheter removal refers to the duration, measured in hours, from the moment the catheter was removed until the patient spontaneously voids for the first time.
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within 1 days after the first time of urethral catheter removal
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The residual urine volume after the first voiding
Time Frame: within 1 days after the first time of urethral catheter removal
|
The residual urine volume after the first voiding is determined by assessing the volume of urine remaining in the bladder immediately after the patient's initial voiding following catheter removal using bladder ultrasonography.
|
within 1 days after the first time of urethral catheter removal
|
Graded assessment of catheter-related bladder discomfort (CRBD)
Time Frame: within 1 days after the first time of urethral catheter removal
|
CRBD is a questionnaire given to the patients, to investigate the severity of the discomfort of patients to the urinary catheter
|
within 1 days after the first time of urethral catheter removal
|
Voiding function
Time Frame: on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
|
Voiding function is evaluated by International Consultation on Incontinence Questionnaire-Short Form (ICIQ-SF) and International Prostate Symptom Score (IPSS).
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on the second day after the first time of urethral catheter removal, and at the 30th day after surgery
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Postoperative complications
Time Frame: within 30 days after the operation
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Complications that occur within 30 days after the operation will be evaluated and documented according to the Clavien-Dindo classification (19).
Complications of grade II or higher were analyzed.
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within 30 days after the operation
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Yuchen Guo, Ph.D, The First Hospital of Jilin University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 21, 2024
Primary Completion (Estimated)
January 30, 2027
Study Completion (Estimated)
January 30, 2028
Study Registration Dates
First Submitted
January 5, 2024
First Submitted That Met QC Criteria
January 18, 2024
First Posted (Actual)
January 22, 2024
Study Record Updates
Last Update Posted (Actual)
April 23, 2024
Last Update Submitted That Met QC Criteria
April 20, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Neoplasms
- Neoplasms by Site
- Urologic Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Gastrointestinal Diseases
- Urination Disorders
- Intestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colorectal Neoplasms
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Rectal Neoplasms
- Urinary Retention
Other Study ID Numbers
- ICCAUT -2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
If other researchers can provide valid reasons or demonstrate a need for additional collaboration, we may consider to share the data upon their request after we complete ours study.
IPD Sharing Time Frame
after we complete ours study.
IPD Sharing Access Criteria
Researchers can provide valid reasons or demonstrate a need for additional collaboration with us
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- ANALYTIC_CODE
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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