Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Trial statusRecruiting
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 urinary catheter removal within 24 hours combined with prophylactic tamsulosin. 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 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).
Patients with a most recent preoperative clinical stage, including restaging after neoadjuvant therapy, of cT0 (clinical complete response [cCR]) to cT4 and cN0-N2 were eligible. For cT4 disease, tumor invasion was limited to the levator ani muscle or external anal sphincter.
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
Tamsulosin group
BehavioralTamsulosin regimen: Tamsulosin 0.4 mg was administered orally once daily at 18:00 from the day before surgery to postoperative day 7. On the day of surgery, if the patient had not returned to the ward by 18:00, the dose was given after return to the ward and recovery from anesthesia. On postoperative day 1, if the patient had not voided within 6 hours after catheter removal or developed lower urinary tract symptoms, the daily dose was administered early and was not repeated at 18:00. Catheter removal: The urinary catheter was removed at 04:00 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.For patients who failed to void within 6 hours after catheter removal or developed lower urinary tract symptoms, oral tamsulosin 0.4 mg was administered, and micturition status was assessed after 4 hours of observation. Thereafter, oral tamsulosin 0.4 mg was given daily at 18:00 for 7 days following catheter removal.
48-Hour Removal Group
BehavioralParticipants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2. For patients who failed to void within 6 hours after catheter removal or developed lower urinary tract symptoms, oral tamsulosin 0.4 mg was administered, and micturition status was assessed after 4 hours of observation. Thereafter, oral tamsulosin 0.4 mg was given daily at 18:00 for 7 days following catheter removal.
Treatment groups
1,545 Participants
are divided into 3 treatment groupsGroup A: Tamsulosin 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
If a patient had not urinated spontaneously by 10 h after catheter removal and had a bladder extending above the pubic symphysis on percussion, or was able to void but had lower urinary tract symptoms (LUTS), and these conditions persisted despite oral tamsulosin, bladder ultrasonography was performed to measure the post-void residual (PVR) urine volume. Recatheterization will be performed if: 1. The PVR volume is \>500 mL, or 300-500 mL with accompanying LUTS; 2. The PVR volume is 300-500 mL without LUTS or ≤300 mL. In these cases, patients are observed for an additional 2-4 h, and recatheterization is performed if no spontaneous voiding occurs or symptoms worsen.
Time frame
Within 7 days after the initial catheter removalSecondary outcomes
1
Incidence of Urinary Tract Infection (UTI).
Urinary Tract Infection is defined as the inflammatory response of the urinary tract epithelium to bacterial invasion. 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 UTI is calculated as a ratio: UTI cases occurring after first catheter removal divided by the total number of enrolled participants.
Time frame
Within 7 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
Recatheterization rate within 30 days after urinary catheter removal
Recatheterization within 30 days was defined as reinsertion of a urinary catheter for any reason after initial catheter removal.
Time frame
Within 30 days after the initial catheter removal4
The incidence of events triggering oral tamsulosin after catheter removal (24-Hour Removal Group and 48-Hour Removal Group) or triggering early oral tamsulosin administration (Tamsulosin Group).
Tamsulosin administration is triggered by either of the following: (1) failure to void spontaneously within 6 hours after urinary catheter removal; or (2) the occurrence of lower urinary tract symptoms at any time, including a sensation of incomplete bladder emptying, urinary urgency, urinary frequency, intermittent urine flow, straining to void, bladder pain or distension, urgency urinary incontinence, or suspected overflow incontinence. For participants in Tamsulosin Group, if any of the above conditions occurs before the scheduled 18:00 dose, that day's dose is administered immediately, is not repeated at 18:00, and the event is recorded as a trigger for early oral tamsulosin.
Time frame
Within 7 days after the initial catheter removalSponsors and contacts
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Source ClinicalTrials.gov