Effect of ICCAUT Strategy on Postoperative Urinary Retention After Radical Rectal Cancer Surgery (ICCAUT-2)

J

Jilin University

Status

Suspended

Conditions

Urinary Retention
Urinary Catheterization
Rectal Cancer

Treatments

Procedure: Free drainage
Procedure: ICCAUT

Study type

Interventional

Funder types

Other

Identifiers

NCT06217016
ICCAUT -2

Details and patient eligibility

About

The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.

Full description

Urinary catheter placement is a standard procedure before proctectomy. However, the necessity of bladder training prior to catheter removal remains uncertain. The objective of this trial is to investigate the effect of bladder training on the incidence of re-catheterization after proctectomy. In this study, the bladder training include intermittent urethral catheter clamping combined with active urination training, which we called ICCAUT strategy. This prospective, single-center, randomized controlled trial will enroll patients with rectal cancer who will be randomized in a 1:1 ratio to the ICCAUT group or the free-drainage group. In the ICCAUT group, patients will undergo intermittent clamping of the urinary catheter before its removal. Each time the catheter is released, we will encourage the patients to actively initiate urination to facilitate complete bladder emptying. While patients in the free-drainage group will not undergo any specific training. The urinary catheter will be removed on the second postoperative day for both groups. The primary endpoint is the incidence of re-catheterization due to urinary retention. Secondary endpoints include urinary tract infection (UTI), time of first urination after catheter removal, residual urine volume after the first urination, postoperative morbidity and mortality within 30 days, as well as urinary function within 30 postoperative days.

Enrollment

1,686 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients with a confirmed preoperative diagnosis of rectal cancer.
  • Patients with tumors located below the rectosigmoid junction, 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.
  • Lateral lymph node dissection for rectal cancer.
  • Injury to the ureter, bladder, or urethra during the perioperative period.
  • Preoperative renal dysfunction (serum creatinine level >133 μmol/L).
  • Emergency surgery.
  • Male patients with preoperative benign prostatic hyperplasia receiving medication treatment.
  • Patients with a ureteral stent or ureteral stricture, or bilateral hydronephrosis.
  • Conversion to open surgery.

Withdrawal Criteria:

After randomization, patients will be withdrawn from the trial if the following situations occur:

  • Inability to remove the urinary catheter within 5 days postoperatively due to various reasons (e.g., impaired consciousness, transfer to the intensive care unit (ICU), Sequential Organ Failure Assessment (SOFA) score ≥2, etc.).
  • Secondary catheterization was performed after catheter removal for reasons other than urinary retention (e.g., secondary surgery, shock, rectal bladder leakage, ureteral leakage, or urethral injury).
  • Patient requests to withdraw from the study at any time during the entire study process.
  • Selective α1-adrenergic receptor blocker is used during the first catheterization of the patient due to medical necessity.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,686 participants in 2 patient groups

ICCAUT Group
Experimental group
Description:
Patients undergoing laparoscopic/robotic rectal cancer TME surgery will undergo bladder training. The bladder training include intermittent catheter clamping and active urination to facilitate complete bladder emptying each time the catheter is released, which we called ICCAUT strategy. The training will commence at 9:00 am on the first postoperative day, and the catheter will be removed at 9:00 am on the second postoperative day.
Treatment:
Procedure: ICCAUT
Free Drainage Group
Other group
Description:
Patients undergoing laparoscopic/robotic rectal cancer TME surgery will have their urinary catheter kept open postoperatively, and the catheter will be removed at 9:00 am on the second postoperative day.
Treatment:
Procedure: Free drainage

Trial contacts and locations

0

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Central trial contact

Yuchen Guo, Ph.D

Data sourced from clinicaltrials.gov

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