NCT07346586Recruiting
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 · Last updated 29 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 1545 (estimated)
- First submitted
- 21 Dec 2025
- Start date
- Mar 2026
- Primary completion date
- Nov 2029
- Lead sponsor
- The First Hospital of Jilin University
- Diseases
- Colorectal cancer, Childhood cancers
- NCT number
- NCT07346586
What you commit to
- Study type: Interventional
- Planned participants: 1545
- From Mar 2026 to the primary completion date, Nov 2029
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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).
- Previously diagnosed overactive bladder syndrome, prior AUR or voiding dysfunction, or diabetic cystopathy.
- 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).
- Patients undergoing emergency surgery.
- Male patients with preoperative benign prostatic hyperplasia requiring medication.
- Previous use of an α1-adrenergic receptor blocker.
Other illness
- History of urethral trauma, intracranial surgery, spinal surgery, cerebral infarction with limb dysfunction, or Parkinson's disease.
Lab values
- Preoperative renal insufficiency (serum creatinine level \>133 μmol/L).
Other
- Inability to void urethrally preoperatively due to any reason (e.g., ureteral puncture, ureterostomy).
- Preoperative assessment indicating potential need for lateral pelvic lymph node dissection.
- Presence of indwelling ureteral stents, ureteral stenosis, or bilateral hydronephrosis.
- Severe lower urinary tract symptoms based on the preoperative International Prostate Symptom Score (IPSS).
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Hospital of Jilin University Coordinator of this site? Confirm its status | Changchun | China | Recruiting |
| Harbin Medical University Cancer Hospital Coordinator of this site? Confirm its status | Harbin | China | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.