Effect of Individualized Catheter Management on Early Removal After Rectal Cancer Surgery
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorThe First Hospital of Jilin University
About this trial
This study aims to systematically evaluate the safety and efficacy of different early urinary catheter removal strategies following radical resection of mid-low rectal cancer. Current clinical practice faces controversy regarding the optimal timing of catheter removal (24 hours vs. 48 hours) and lacks precise preventive measures for patients at high risk of postoperative acute urinary retention (AUR). To address these issues, this study is designed as a three-arm randomized controlled trial, directly comparing three management protocols: catheter removal at 24 hours postoperatively, catheter removal at 48 hours postoperatively, and an individualized strategy guided by a predictive model (i.e., preventive administration of tamsulosin to high-risk AUR patients prior to catheter removal). The primary endpoint is the rate of recatheterization within 7 days after the initial removal, with secondary endpoints comprehensively assessing urinary tract infections, voiding function, and postoperative complications. The ultimate goal is to provide high-quality evidence-based medical evidence to establish a precise and standardized clinical pathway for individualized postoperative catheter management.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with a preoperative pathological confirmation of rectal malignant tumor.
Preoperative colorectal CT or rectal MRI confirming that the lower edge of the tumor is located in the rectum within 10 cm from the anal verge (including rectal and anal canal lesions).
Patients scheduled to undergo laparoscopic or robot-assisted radical total mesorectal excision (TME).
Disqualifiers
History of previous abdominal surgery involving the rectum/sigmoid colon/left colon, bladder resection or partial resection, prostate surgery (in males), or hysterectomy (in females).
History of urethral trauma, intracranial surgery, spinal surgery, cerebral infarction with limb dysfunction, or Parkinson's disease.
Inability to void urethrally preoperatively due to any reason (e.g., ureteral puncture, ureterostomy).
Previously diagnosed overactive bladder syndrome, prior AUR or voiding dysfunction, or diabetic cystopathy.
Trial design
Design model
Parallel
Treatments tested in this trial
Individualized Management Group
BehavioralParticipants assessed by the AUR risk prediction model immediately postoperatively. High-risk patients receive prophylactic tamsulosin until catheter removal. All patients have their catheter removed at 4:00 AM on postoperative day 1.
24-Hour Removal Group
BehavioralParticipants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.
48-Hour Removal Group
BehavioralParticipants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2.
Treatment groups
1,545 Participants
are divided into 3 treatment groupsGroup A: Individualized Management GroupExperimental treatment 1 intervention
Group B: 24-Hour Removal GroupExperimental treatment 1 intervention
Group C: 48-Hour Removal GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Rate of recatheterization within 7 days after the initial catheter removal
Recatheterization will be performed if the patient meets any of the following criteria for acute urinary retention (AUR) after catheter removal: Criterion 1: Inability to void spontaneously within 6 hours of catheter removal, with a post-void residual volume (PVR) \>300ml on bladder ultrasound, which persists (\>300ml) after a trial of oral tamsulosin and an additional 4-hour observation period. Criterion 2: Persistent and strong urge to void with minimal urine output, frequency, sensation of bladder fullness, bladder pain, or new-onset incontinence, coupled with a PVR \>300ml on bladder ultrasound. Criterion 3: Patient request for recatheterization due to severe discomfort from bladder distension, provided that the volume of urine immediately obtained exceeds 200ml.
Time frame
Rate of recatheterization within 7 days after the initial catheter removalSecondary outcomes
1
Incidence of Catheter-Associated Urinary Tract Infection (CAUTI).
Catheter-Associated Urinary Track Infection is defined as the inflammatory response of the urinary tract epithelium to bacterial invasion related to catheter placement. The diagnosis must simultaneously satisfy the following two criteria: 1) Urinalysis indicates that the urinary bacterial count exceeds the upper limit of the normal range, and 2) Urine culture is positive. Incidence of Catheter-Associated Urinary Tract Infection (CAUTI) is calculated as a ratio: UTI cases occurring after first catheter removal divided by the total number of enrolled participants.
Time frame
within 1 days after the initial catheter removal2
Time to First Successful Voiding after Catheter Removal
The time to first void after catheter removal is defined as the period from the time of catheter removal to the time when the patient voids spontaneously, measured in hours.
Time frame
within 1 days after the initial catheter removal3
Voiding function assessed by the ICIQ-SF questionnaires after catheter removal
ICIQ-SF(International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form), minimum / maximum (total score ) is 0 to 21, higher scores means worse outcome(greater severity/impairment from urinary incontinence).
Time frame
within 2 days after the initial catheter removal4
Voiding function assessed by the lPSS questionnaires after catheter removal
IPSS(International Prostate Symptom Score) , Minimum / maximum (symptom score): 0 to 35 the single quality-of-life question is scored 0 to 6 ("delighted" → "terrible"), where higher means worse QoL; higher scores in total indicates worse outcome (more severe urinary symptoms); Mild (IPSS 0-7): Symptom severity is considered mild, and active treatment is usually not required unless the patient is bothered by symptoms.Moderate (IPSS 8-19): Symptoms are moderate; treatment options (e.g., medication, minimally invasive therapy) should be discussed based on the patient's condition and preferences. Severe (IPSS 20-35): Symptoms are severe and typically require active intervention (e.g., medication, surgery) to improve quality of life.
Time frame
within 2 days after the initial catheter removalSponsors and contacts
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Source ClinicalTrials.gov
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