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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 an individualized strategy guided by a predictive model (i.e., preventive administration of tamsulosin to high-risk AUR patients prior to catheter removal). 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 individualized postoperative catheter management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Individualized Management Group | Experimental | Participants assessed by the AUR risk prediction model immediately postoperatively. High-risk patients receive prophylactic tamsulosin until catheter removal. All patients have their catheter removed at 4:00 AM on postoperative day 1. |
|
| 24-Hour Removal Group | Experimental | Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1. |
|
| 48-Hour Removal Group | Active Comparator | Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Individualized Management Group | Behavioral | Participants assessed by the AUR risk prediction model immediately postoperatively. High-risk patients receive prophylactic tamsulosin until catheter removal. All patients have their catheter removed at 4:00 AM on postoperative day 1. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of recatheterization within 7 days after the initial catheter removal | Recatheterization will be performed if the patient meets any of the following criteria for acute urinary retention (AUR) after catheter removal: Criterion 1: Inability to void spontaneously within 6 hours of catheter removal, with a post-void residual volume (PVR) >300ml on bladder ultrasound, which persists (>300ml) after a trial of oral tamsulosin and an additional 4-hour observation period. Criterion 2: Persistent and strong urge to void with minimal urine output, frequency, sensation of bladder fullness, bladder pain, or new-onset incontinence, coupled with a PVR >300ml on bladder ultrasound. Criterion 3: Patient request for recatheterization due to severe discomfort from bladder distension, provided that the volume of urine immediately obtained exceeds 200ml. | Rate of recatheterization within 7 days after the initial catheter removal |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Catheter-Associated Urinary Tract Infection (CAUTI). | Catheter-Associated Urinary Track Infection is defined as the inflammatory response of the urinary tract epithelium to bacterial invasion related to catheter placement. The diagnosis must simultaneously satisfy the following two criteria: 1) Urinalysis indicates that the urinary bacterial count exceeds the upper limit of the normal range, and 2) Urine culture is positive. Incidence of Catheter-Associated Urinary Tract Infection (CAUTI) is calculated as a ratio: UTI cases occurring after first catheter removal divided by the total number of enrolled participants. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yuchen Guo Yuchen Guo | Contact | +8613630598312 | guoyuchen8688@jlu.edu.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Hospital of Jilin University | Changchun | Jilin | China |
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After we complete our study
Researchers may provide legitimate justification and supporting documentation.
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| ID | Term |
|---|---|
| D012004 | Rectal Neoplasms |
| D016055 | Urinary Retention |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| 24-Hour Removal Group | Behavioral | Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1. |
|
| 48-Hour Removal Group | Behavioral | Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2. |
|
| within 1 days after the initial catheter removal |
| Time to First Successful Voiding after Catheter Removal | The time to first void after catheter removal is defined as the period from the time of catheter removal to the time when the patient voids spontaneously, measured in hours. | within 1 days after the initial catheter removal |
| Voiding function assessed by the ICIQ-SF questionnaires after catheter removal | ICIQ-SF(International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form), minimum / maximum (total score ) is 0 to 21, higher scores means worse outcome(greater severity/impairment from urinary incontinence). | within 2 days after the initial catheter removal |
| Voiding function assessed by the lPSS questionnaires after catheter removal | IPSS(International Prostate Symptom Score) , Minimum / maximum (symptom score): 0 to 35 the single quality-of-life question is scored 0 to 6 ("delighted" → "terrible"), where higher means worse QoL; higher scores in total indicates worse outcome (more severe urinary symptoms); Mild (IPSS 0-7): Symptom severity is considered mild, and active treatment is usually not required unless the patient is bothered by symptoms.Moderate (IPSS 8-19): Symptoms are moderate; treatment options (e.g., medication, minimally invasive therapy) should be discussed based on the patient's condition and preferences. Severe (IPSS 20-35): Symptoms are severe and typically require active intervention (e.g., medication, surgery) to improve quality of life. | within 2 days after the initial catheter removal |
| Incidence, types, and severity (graded by Clavien-Dindo classification) of postoperative complications within 30 days. | The Clavien-Dindo classification includes, but is not limited to, intra-abdominal hemorrhage, gastrointestinal bleeding, anastomotic leakage, chyle leakage, surgical site infection (intra-abdominal infection and incisional infection), intestinal obstruction, postoperative diarrhea, pulmonary infection, urinary tract infection, cardiovascular accident, cerebrovascular accident, and thrombotic diseases. | within 30 days postoperatively |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D014555 | Urination Disorders |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |