Trial Title:
Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery
NCT ID:
NCT06241703
Condition:
Urinary Dysfunction
Rectal Cancer
Urinary Catheterization
Urinary Retention Postoperative
Conditions: Official terms:
Rectal Neoplasms
Urinary Retention
Conditions: Keywords:
Residual Urine Volume
Urinary Retention
Urinary Dysfunction
Rectal Cancer
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Investigator, Outcomes Assessor)
Masking description:
The patients and bedside nurses cannot be blinded, but the attending physicians and the
medical ultrasound doctor will be blinded. The medical team will ensure that the patients
and bedside nurses keep the group assignment confidential from the attending physicians
and the medical ultrasound doctor. Unblinding will occur when the patient is discharged,
and any instances of premature unblinding will be recorded. Additionally, the data
analysts involved in this study will be blinded.
Intervention:
Intervention type:
Procedure
Intervention name:
ICCAUT
Description:
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 after the bladder is
empty. 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.
Arm group label:
ICCAUT Group
Intervention type:
Procedure
Intervention name:
Free drainage
Description:
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.
Arm group label:
Free Drainage Group
Summary:
In this study, the bladder training include intermittent urethral catheter clamping
combined with active urination training, which the investigators called ICCAUT strategy.
This prospective, single-center, randomized controlled trial will recruit participants
with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either
the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will
undergo intermittent clamping of the urinary catheter prior to its removal. Each time the
catheter is released, the investigators will encourage the participants to actively
initiate urination to facilitate complete bladder emptying. While participants in the
free-drainage group will not receive any specific training. The urinary catheter will be
removed on the second day after the surgery for both groups after the bladder is empty.
The primary endpoint is the incidence of urinary dysfunction, which include secondary
catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract
infection, time to first urination after catheter removal, catheter-related bladder
discomfort syndrome, postoperative morbidity and mortality, as well as urinary function
within 30 days.
Detailed description:
Urinary catheter placement is a routine procedure performed in proctectomy. Nevertheless,
there is uncertainty regarding the need for bladder training before catheter removal. The
purpose of this trial is to examine the impact of bladder training on the urinary
retention and secondary catheterization following proctectomy.
In this study, the bladder training include intermittent urethral catheter clamping
combined with active urination training, which the investigators called ICCAUT strategy.
This prospective, single-center, randomized controlled trial will recruit participants
with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either
the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will
undergo intermittent clamping of the urinary catheter prior to its removal. Each time the
catheter is released, the investigators will encourage the participants to actively
initiate urination to facilitate complete bladder emptying. While the participants in the
free-drainage group will not receive any specific training. The urinary catheter will be
removed on the second day after the surgery for both groups after the bladder is empty.
The primary endpoint is the incidence of urinary dysfunction, which include secondary
catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract
infection, time to first urination after catheter removal, catheter-related bladder
discomfort syndrome, postoperative morbidity and mortality, as well as urinary function
within 30 days.
This trial aims to investigate whether ICCAUT strategy, achieved through intermittent
clamping of the catheter combined with active urination training in patients undergoing
rectal cancer surgery, can impact the rate of urinary dysfunction compared to direct
catheter removal. The findings from this study will provide valuable evidence regarding
the manipulation of urinary catheters and help guide clinical practice.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Patients with a confirmed preoperative diagnosis of rectal cancer.
2. Patients with tumors located below the rectosigmoid junction, as determined by
preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
3. Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME)
for rectal cancer.
Exclusion Criteria:
1. History of abdominal surgery involving the rectum, sigmoid colon, left
hemicolectomy, bladder resection or partial resection, prostate surgery, or
hysterectomy.
2. History of urethral injury, cranial surgery, spinal surgery, stroke with limb
dysfunction, or Parkinson's disease.
3. Inability to urinate through the urethra preoperatively due to various reasons
(e.g., ureteral puncture or ureterostomy).
4. Presence of urinary tract infection preoperatively.
5. Previously diagnosed with bladder overactivity syndrome, urinary retention or
voiding dysfunction, or diabetic bladder disease.
6. Concomitant resection of other pelvic organs was performed during surgery, including
the bladder, prostate, uterus, cervix, and vagina, except for simple adnexal
resection.
7. Lateral lymph node dissection for rectal cancer.
8. Injury to the ureter, bladder, or urethra during the perioperative period.
9. Preoperative renal dysfunction (serum creatinine level >133 μmol/L).
10. Emergency surgery.
11. Male patients with preoperative benign prostatic hyperplasia receiving medication
treatment.
12. Patients with a ureteral stent or ureteral stricture, or bilateral hydronephrosis.
13. Conversion to open surgery.
Withdrawal Criteria:
After randomization, patients will be withdrawn from the trial if the following
situations occur:
1. 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.).
2. 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).
3. Patient requests to withdraw from the study at any time during the entire study
process.
4. Selective α1-adrenergic receptor blocker is used during the first catheterization of
the patient due to medical necessity.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
First Hospital of Jilin University
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Recruiting
Contact:
Last name:
Yuchen Guo, Ph.D.
Phone:
+8613630598312
Email:
guoyuchen8688@live.com
Start date:
March 20, 2024
Completion date:
February 19, 2026
Lead sponsor:
Agency:
The First Hospital of Jilin University
Agency class:
Other
Source:
The First Hospital of Jilin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06241703
