Clinical trial · Interventional
Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.
Prospective, Controlled, Randomized Multicentric Study of Non-inferiority on the Management of the Vesical Catheter in Colon Surgery. CR-Vesical Cath Study Group
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
INTRODUCTION: Recommendations for peroperative bladder catheterization remain a controversial issue since it is a procedure that is not without complications. Most of the current suggestions derive from open surgery data that have been extrapolated to Enhanced Recovery After Surgery (ERAS) or Fast-Track programs ranging between 24-48 hours. The objective of the present study is to find the perfect balance with a better degree of evidence than the current one between the reduction of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery. Methods: Multicenter, prospective, controlled, randomized non-inferiority study on the management of the bladder catheter in patients undergoing scheduled laparoscopic colon surgery, randomized in two study groups: experimental group (removal of the bladder catheter after surgery ) and control group (removal of the catheter at 24 hours) after the surgical intervention. The main objective of the present study is to reduce the permanence of the bladder catheter trying to find the balance of the probing time and the non-increase of the acute retention of urine in the patients operated in a programmed way of laparoscopic colon surgery As secondary objectives we will consider the decrease in the incidence of urinary tract infections within the first 30 days as well as the reduction in hospital stay and morbidity related to the bladder catheter.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Remove urinary catheter after surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- control group
- description
- Bladder catheter removal 24 hours after surgery
- type
- EXPERIMENTAL
- label
- experimental group
- description
- Removal of the bladder catheter after the surgical intervention
- interventionNames
- Procedure: Remove urinary catheter after surgery
Primary outcomes (1)
- measure
- Development of acute urine retention after removal of the bladder catheter after colon surgery.
- timeFrame
- 8 hours
- description
- Acute urine retention is defined as * the inability to spontaneous urination at 8 hours after the removal of the bladder catheter * obtaining after urinary catheterization of more than 400 cc of urine or the need for repeated probing due to the impossibility of spontaneous urination
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Inclusion Criteria: * Any patient who understands, agrees to participate and signs the informed consent * older than 18 years-old * electively operated and programmed laparoscopically of the colon and upper rectum in which peritoneal reflection has not been opened * duration of the surgical act less than 180 minutes * Prior anesthetic assessment of ASA I-III * International prostate symptom score (IPSS) of less than 19 with / without treatment for BPH (alpha-blocker). Exclusion Criteria: * \- Open surgery or conversion to open surgery * Performing periodic anesthesia or being ASA IV * Preoperative diagnosis of recurrent urinary tract infections (more than 3 episodes / year documented by urinoculture or two urinary tract infections in the last 6 months); * Moderate-severe prostate clinic (IPSS\> 19) * Presence of positive urine culture in men in preoperative tests * Urinary infection clinic in women with positive urine culture * Previous history of acute urine retention * be a permanent bladder catheter or ureteral catheter and perform intermittent autocatheterization. * men who underwent prostate surgery * patients with a history of treatment for urological tumor - patients with a history of urethral stricture, enterovesical fistula or previous pelvic surgery. * urinary incontinence or neurogenic bladder * chronic renal failure (CRF) with creatinine levels greater than 2 (including terminal CRI stage or dialysis) * emergency surgery pregnant * have received pelvic radiotherapy * Administration of serum during the operative time\> 2,000ml.
References
Publications (0)
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