Clinical trial · Interventional
Tamsulosin for Early Catheter Removal After Rectal Cancer Surgery
Safety and Efficacy of Oral Tamsulosin in Facilitating Early Urinary Catheter Removal After Surgery for Mid- and Low Rectal Cancer: A Randomized Controlled Trial (ICCAUT-3)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 30, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260930-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Catheters | — | UNRESOLVED | — |
| Urinary Retention | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 24-Hour Removal Group | Behavioral | — | UNRESOLVED |
| 48-Hour Removal Group | Behavioral | — | UNRESOLVED |
| Tamsulosin group | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Tamsulosin Group
- description
- Participants assigned to this arm underwent urinary catheter removal at 04:00 AM on postoperative day 1 and received prophylactic oral tamsulosin 0.4 mg once daily from one day before surgery through postoperative day 7.
- interventionNames
- Behavioral: Tamsulosin group
- type
- EXPERIMENTAL
- label
- 24-Hour Removal Group
- description
- Participants do not receive prophylactic tamsulosin before urinary catheter removal. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.Oral tamsulosin (0.4 mg once daily) was initiated if patients failed to void spontaneously within 6 hours after urinary catheter removal or developed lower urinary tract symptoms.
- interventionNames
- Behavioral: 24-Hour Removal Group
- type
- ACTIVE_COMPARATOR
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Patients with a preoperative pathological confirmation of rectal malignant tumor. 2. 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). 3. Patients scheduled to undergo laparoscopic or robot-assisted radical total mesorectal excision (TME). 4. 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. Exclusion Criteria: 1. 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). 2. History of urethral trauma, intracranial surgery, spinal surgery, cerebral infarction with limb dysfunction, or Parkinson's disease. 3. Inability to void urethrally preoperatively due to any reason (e.g., ureteral puncture, ureterostomy). 4. Previously diagnosed overactive bladder syndrome, prior AUR or voiding dysfunction, or diabetic cystopathy. 5. Preoperative assessment indicating potential need for combined resection of other pelvic organs during surgery, including the bladder, prostate, uterus and cervix, or vagina (excluding simple adnexectomy in females). 6. Preoperative assessment indicating potential need for lateral pelvic lymph node dissection. 7. Preoperative renal insufficiency (serum creatinine level \>133 μmol/L). 8. Patients undergoing emergency surgery. 9. Male patients with preoperative benign prostatic hyperplasia requiring medication. 10. Presence of indwelling ureteral stents, ureteral stenosis, or bilateral hydronephrosis. 11. Severe lower urinary tract symptoms based on the preoperative International Prostate Symptom Score (IPSS). 12. Previous use of an α1-adrenergic receptor blocker.
References
Publications (0)
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