An interventional study of Tamsulosin group and 24-Hour Removal Group in Urinary Catheters, Rectal Cancer and Urinary Retention, sponsored by The First Hospital of Jilin University. Recruiting at 2 sites in China. Per ClinicalTrials.gov, last updated 2026-09-29.
Sponsored by The First Hospital of Jilin University · Not applicable, Interventional, and Prevention
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Among 11 studies in Rectal Neoplasms by The First Hospital of Jilin University — 6 open to participants now, 7 under way, 2 of them phase 3. Rectal Neoplasms · The First Hospital of Jilin University.
Among the 11 studies in Rectal Neoplasms by The First Hospital of Jilin University, this one has the largest planned enrollment of the 10 interventional ones that give a count, is one of 3 that started in 2026, is one of 6 with no phase, and was the 9th registered.
2,402 studies on the registry are indexed under Rectal Neoplasms; 589 are open to participants now.
Browse Rectal Neoplasms studies →6 of the 11 studies in Rectal Neoplasms by The First Hospital of Jilin University are open now, in 1 country. Recruiting first, the newest first:
The First Hospital of Jilin University · Sites in China
Ages 18–75
The First Hospital of Jilin University · Sites in China
Ages 18–75
The First Hospital of Jilin University · Sites in China
Ages 18–75
The First Hospital of Jilin University · Sites in China
Ages 18–75
The First Hospital of Jilin University · Sites in China
Ages 18–75
By country, each count listing its studies:
Of the 405 Rectal Neoplasms studies recruiting now, 210 (52%) set no upper age limit and 143 (35%) stop at 75 or younger; 19 take children under 18; 16 take healthy volunteers.
This study: all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
11 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 1 · Phase 2 3 · Phase 3 2
First in 2021; this study’s year is marked. 3 started in 2026.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 1,545 is above the median of 65 across 1,753 interventional studies indexed under Rectal Neoplasms.
Median enrollment 136 across the 10 interventional studies, 300 across the 1 observational. Of the 2 that completed or were terminated, 0 (0%) have results posted.
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The First Hospital of Jilin University is the lead sponsor of 186 studies on the registry; 97 are open to participants now.
1 of the studies in Rectal Neoplasms by The First Hospital of Jilin University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05998122The First Hospital of Jilin UniversityTotal Neoadjuvant Chemoradiotherapy Plus Anti-PD-1 in Subperitoneal Patients With Locally Advanced Rectal CancerPatients With Locally Advanced Rectal Cancer: A Prospective, Single Arm, Exploratory Study | 2026-12-31 |
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Among the 11 studies in Rectal Neoplasms by The First Hospital of Jilin University, from their registry updates:
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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 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.
The criteria were revised on the registry on Sep 29, 2026. See what changed
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants assigned to this arm underwent urinary catheter removal at 04:00 AM on postoperative day 1 and received prophylactic oral tamsulosin 0.4 mg once daily from one day before surgery through postoperative day 7.
Behavioral: Tamsulosin group
Participants do not receive prophylactic tamsulosin before urinary catheter removal. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.Oral tamsulosin (0.4 mg once daily) was initiated if patients failed to void spontaneously within 6 hours after urinary catheter removal or developed lower urinary tract symptoms.
Behavioral: 24-Hour Removal Group
Participants do not receive prophylactic tamsulosin before urinary catheter removal. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2.Oral tamsulosin (0.4 mg once daily) was initiated if patients failed to void spontaneously within 6 hours after urinary catheter removal or developed lower urinary tract symptoms.
Behavioral: 48-Hour Removal Group
Tamsulosin regimen: Tamsulosin 0.4 mg was administered orally once daily at 18:00 from the day before surgery to postoperative day 7. On the day of surgery, if the patient had not returned to the ward by 18:00, the dose was given after return to the ward and recovery from anesthesia. On postoperative day 1, if the patient had not voided within 6 hours after catheter removal or developed lower urinary tract symptoms, the daily dose was administered early and was not repeated at 18:00. Catheter removal: The urinary catheter was removed at 04:00 on postoperative day 1.
Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 1.For patients who failed to void within 6 hours after catheter removal or developed lower urinary tract symptoms, oral tamsulosin 0.4 mg was administered, and micturition status was assessed after 4 hours of observation. Thereafter, oral tamsulosin 0.4 mg was given daily at 18:00 for 7 days following catheter removal.
Participants do not receive prophylactic tamsulosin. The urinary catheter is removed uniformly at 4:00 AM on postoperative day 2. For patients who failed to void within 6 hours after catheter removal or developed lower urinary tract symptoms, oral tamsulosin 0.4 mg was administered, and micturition status was assessed after 4 hours of observation. Thereafter, oral tamsulosin 0.4 mg was given daily at 18:00 for 7 days following catheter removal.
Rate of recatheterization within 7 days after the initial catheter removal
If a patient had not urinated spontaneously by 10 h after catheter removal and had a bladder extending above the pubic symphysis on percussion, or was able to void but had lower urinary tract symptoms (LUTS), and these conditions persisted despite oral tamsulosin, bladder ultrasonography was performed to measure the post-void residual (PVR) urine volume. Recatheterization will be performed if: 1. The PVR volume is \>500 mL, or 300-500 mL with accompanying LUTS; 2. The PVR volume is 300-500 mL without LUTS or ≤300 mL. In these cases, patients are observed for an additional 2-4 h, and recatheterization is performed if no spontaneous voiding occurs or symptoms worsen.
Time frame: Within 7 days after the initial catheter removal
Incidence of Urinary Tract Infection (UTI).
Urinary Tract Infection is defined as the inflammatory response of the urinary tract epithelium to bacterial invasion. 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 UTI is calculated as a ratio: UTI cases occurring after first catheter removal divided by the total number of enrolled participants.
Time frame: Within 7 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.
Time frame: Within 1 days after the initial catheter removal
Recatheterization rate within 30 days after urinary catheter removal
Recatheterization within 30 days was defined as reinsertion of a urinary catheter for any reason after initial catheter removal.
Time frame: Within 30 days after the initial catheter removal
The incidence of events triggering oral tamsulosin after catheter removal (24-Hour Removal Group and 48-Hour Removal Group) or triggering early oral tamsulosin administration (Tamsulosin Group).
Tamsulosin administration is triggered by either of the following: (1) failure to void spontaneously within 6 hours after urinary catheter removal; or (2) the occurrence of lower urinary tract symptoms at any time, including a sensation of incomplete bladder emptying, urinary urgency, urinary frequency, intermittent urine flow, straining to void, bladder pain or distension, urgency urinary incontinence, or suspected overflow incontinence. For participants in Tamsulosin Group, if any of the above conditions occurs before the scheduled 18:00 dose, that day's dose is administered immediately, is not repeated at 18:00, and the event is recorded as a trigger for early oral tamsulosin.
Time frame: Within 7 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.
Time frame: within 30 days postoperatively
Plan to share: Yes
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code
Time frame: After we complete our study
Access criteria: Researchers may provide legitimate justification and supporting documentation.
No publications or documents are linked to this record.
Started Mar 2026 (actual). Primary completion is estimated for Nov 2029, 44 months after the start.
Of 329 non-industry interventional studies with no phase under Rectal Neoplasms, half reached primary completion within 51 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 78. This study's planned 44 months is below that.
Counting every sponsor, half of 336 studies reached it within 51 months; a quarter within 23 and three quarters within 78.
Start moved once since we started tracking on Sep 25, 2026: Feb 2026 → Mar 2026, on Sep 29, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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The First Hospital of Jilin University →