Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery (NCT06241703) | Clinical Trial Compass
CompletedNot Applicable
Effect of ICCAUT Strategy on Postoperative Urinary Dysfunction After Radical Rectal Cancer Surgery
China400 participantsStarted 2024-03-20
Plain-language summary
In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which the investigators called ICCAUT strategy. This prospective, single-center, randomized controlled trial will recruit participants with rectal cancer. The participants will be randomly assigned in a 1:1 ratio to either the ICCAUT group or the free-drainage group. In the ICCAUT group, the participants will undergo intermittent clamping of the urinary catheter prior to its removal. Each time the catheter is released, the investigators will encourage the participants to actively initiate urination to facilitate complete bladder emptying. While participants in the free-drainage group will not receive any specific training. The urinary catheter will be removed on the second day after the surgery for both groups after the bladder is empty. The primary endpoint is the incidence of urinary dysfunction, which include secondary catheterization or incomplete bladder emptying. Secondary endpoints include urinary tract infection, time to first urination after catheter removal, catheter-related bladder discomfort syndrome, postoperative morbidity and mortality, as well as urinary function within 30 days.
Who can participate
SexALL
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Inclusion criteria
✓. Patients with a confirmed preoperative diagnosis of rectal cancer.
✓. Patients with tumors located below the rectosigmoid junction (12 cm from the anal verge), as determined by preoperative computed tomography (CT) or rectal magnetic resonance imaging (MRI).
✓. Patients undergoing laparoscopic or robotic-assisted total mesorectal excision (TME) for rectal cancer.
Exclusion criteria
✕. History of abdominal surgery involving the rectum, sigmoid colon, left hemicolectomy, bladder resection or partial resection, prostate surgery, or hysterectomy.
✕. History of urethral injury, cranial surgery, spinal surgery, stroke with limb dysfunction, or Parkinson's disease.
✕. Inability to urinate through the urethra preoperatively due to various reasons (e.g., ureteral puncture or ureterostomy).
✕. Presence of urinary tract infection preoperatively.
✕. Previously diagnosed with bladder overactivity syndrome, urinary retention or voiding dysfunction, or diabetic bladder disease.
✕. Concomitant resection of other pelvic organs was performed during surgery, including the bladder, prostate, uterus, cervix, and vagina, except for simple adnexal resection.
What they're measuring
1
Rate of urinary dysfunction
Timeframe: within 7 days after the first time of urethral catheter removal