Tamsulosin and Early Catheter Removal After Rectal Cancer Surgery

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized three-arm study compares three strategies for postoperative catheter management after radical rectal cancer surgery: removal at 24 hours, removal at 48 hours, and removal within 24 hours with prophylactic tamsulosin. The primary outcome is recatheterization within 7 days of initial removal, with secondary endpoints including urinary tract infections, voiding function, and overall postoperative complications. The trial targets patients undergoing laparoscopic or robot-assisted total mesorectal excision and aims to provide high-quality evidence to guide timing of catheter removal and prevention of acute urinary retention. Enrollment is limited to adults with confirmed rectal cancer and specific tumor location criteria, across two collaborating centers in China. Results could influence postoperative care protocols and patient comfort after rectal cancer surgery.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Hospital of Jilin University
  Changchun, Jilin, China Recruiting
• Harbin Medical University Cancer Hospital
  Harbin, Heilongjiang, China Not yet recruiting

Study contacts

• Study coordinator: Yuchen Guo Yuchen Guo
• Email: guoyuchen8688@jlu.edu.cn
• Phone: +8613630598312

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Single vs. double stapling and purse-string techniques after rectal cancer surgery

  This trial tests whether using a single-stapling method to join the bowel after rectal cancer surgery results in fewer leaks compared with the double-stapling method.

  Recruiting Alexandria University · Alexandria · NCT07929415

• DEM301 in advanced colorectal cancer: a first-in-human test

  This first-in-human Phase 1 study tests DEM301 in adults with advanced metastatic colorectal cancer to see if it is safe, how it behaves in the body, and whether it shows any signs of activity.

  Recruiting at 2 sites Phase 1 DEM BioPharma, Inc. · Birtinya, Queensland and 1 other locations · NCT07805369

• NowCath Foley: a new catheter to lower bladder infections and blockages for long-term users

  A new silicone indwelling catheter with extra drainage eyelets and a flexible skirt is being tested to see if it reduces catheter-associated urinary tract infections and blockages in adults who need long-term Foley catheters.

  Recruiting at 3 sites Nowwell AS · Herning and 2 other locations · NCT07782762

• Rectal cancer registry to track real-world treatments and outcomes

  This registry collects real-world data on how locally advanced rectal cancer is treated in Austria, to see how TNT and dMMR/MSI-H cases are managed and what outcomes occur.

  Recruiting at 2 sites Austrian Breast & Colorectal Cancer Study Group · Wiener Neustadt, Lower Austria and 5 other locations · NCT07780305

• Aerobic exercise and guided imagery for bowel problems after rectal cancer surgery

  This study tests whether a program of aerobic exercise plus guided imagery helps people with low anterior resection syndrome after rectal cancer surgery.

  Recruiting Biruni University · Istanbul · NCT07732894

• Investigational Intermittent Catheter: First Look at Safety and Usability

  This study tests a new intermittent catheter in adult men who already self-catheterize to see if it is safe and easy to use compared with their current catheter.

  Recruiting Hollister Incorporated · Libertyville, Illinois · NCT07714694

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.