Status:

UNKNOWN

Prospective, Controlled, Randomized Multicentric Study on the Management of the Vesical Catheter in Colon Surgery.

Lead Sponsor:

Corporacion Parc Tauli

Conditions:

Colon Cancer

Eligibility:

All Genders

18-100 years

Phase:

NA

Brief Summary

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 fr...

Detailed Description

INTRODUCTION: The usual recommendations for a peroperative bladder catheter vary from surgical reasons to the control of hemodynamics or personal preferences, so since it is not a procedure free of co...

Eligibility Criteria

Inclusion

  • 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

  • \- 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.

Key Trial Info

Start Date :

September 15 2019

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

416 Patients enrolled

Trial Details

Trial ID

NCT04070898

Start Date

September 15 2019

End Date

December 31 2022

Last Update

November 16 2021

Active Locations (1)

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1

Hospital Universitario Parc Tauli de Sabadell

Sabadell, Barcelona, Spain, 08208