Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01508767
Recruitment Status : Completed
First Posted : January 12, 2012
Last Update Posted : August 19, 2013
Sponsor:
Information provided by (Responsible Party):
Myles Joyce, University College Hospital Galway

Tracking Information
First Submitted Date  ICMJE January 4, 2012
First Posted Date  ICMJE January 12, 2012
Last Update Posted Date August 19, 2013
Study Start Date  ICMJE January 2012
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
Post-operative urinary retention requiring re-catheterisation [ Time Frame: 14 days following urethral catheter removal ]
Development of acute post-operative urinary retention demonstrated by a post-void residual >100mls on bladder ultrasound requiring re-catheterisation within 2 weeks of removal of urethral catheter in the post-operative period.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01508767 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: January 9, 2012)
  • Symptomatic bacteruria [ Time Frame: Within 14 days of urethral catheter removal ]
    Should a patient experience lower urinary tract symptoms following catheter removal a mid-stream urine sample will be taken for microscopy and culture. A pure culture of a single organism of >100,000 colony forming units will be considered a positive culture.
  • Pulmonary complications [ Time Frame: For the first 14 days post-operatively ]
    The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.
  • Surgical site infection [ Time Frame: Within 7 days post-operatively ]
    The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Official Title  ICMJE Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Brief Summary

Patients undergoing colon or rectal surgery will usually have a urinary catheter (silicone tube) placed in the bladder at the time of operating to monitor kidney function during surgery and in the post-surgery period. Such patients will also have an infusion into the spine, known as an epidural, after surgery to provide them with continuous pain relief. Urinary catheters should be removed as early as possible once they are no longer required to facilitate patients becoming mobile after surgery and to reduce the risk of patients developing a urinary tract infection.

Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.

Detailed Description Patients undergoing colon or rectal surgery will be randomly assigned to one of two groups: Patients in study group 1 (SG1) will have their urinary catheters removed at 48 hours post-operatively; Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period. We will be primarily examining rates of urinary retention in both groups. We will also be examining rates of urinary tract infection, chest infection (frequently a result of poor mobility after surgery), and wound infection and other complications after surgery.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Urinary Retention
Intervention  ICMJE Other: Removal of urethral catheter
All participants are to have a urethral catheter placed following successful placement of an epidural catheter for analgesia prior to undergoing colorectal resection. Following urethral catheter placement participants will be randomly assigned to either the experimental arm or the control arm. Participants assigned to the experimental arm will have their urethral catheters removed at 48 hours following surgery. Participants assigned to the control group will have their urethral catheters removed within 12 hours of withdrawal of the epidural infusion, as is standard practice in our institution.
Other Names:
  • Urethral catheter
  • Indwelling Urinary catheter
  • Indwelling urethral catheter
Study Arms  ICMJE
  • Experimental: Study group 1
    Early removal of urethral catheter 48 hours post-operatively.
    Intervention: Other: Removal of urethral catheter
  • Study group 2
    Removal of urethral catheter once epidural analgesia has been withdrawn.
    Intervention: Other: Removal of urethral catheter
Publications * Coyle D, Joyce KM, Garvin JT, Regan M, McAnena OJ, Neary PM, Joyce MR. Early post-operative removal of urethral catheter in patients undergoing colorectal surgery with epidural analgesia – a prospective pilot clinical study. Int J Surg. 2015 Apr;16(Pt A):94-98. doi: 10.1016/j.ijsu.2015.03.003. Epub 2015 Mar 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: August 16, 2013)
41
Original Estimated Enrollment  ICMJE
 (submitted: January 9, 2012)
72
Actual Study Completion Date  ICMJE July 2013
Actual Primary Completion Date July 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Age > 18
  • Competent to consent to participate in trial
  • Undergoing colorectal surgery (any resection of large bowel, formation of colostomy, anterior resection, low anterior resection, panproctocolectomy, abdominoperineal resection).
  • Receiving epidural analgesia post-operatively
  • If male, international prostate symptom score <20.

Exclusion Criteria:

  • Previous lower urinary tract surgery
  • Chronic lower urinary tract disease
  • Intermittent self-catheterisation
  • Neurogenic bladder
  • Urethral catheter inserted >24 hours pre-operatively
  • Presence of pelvic sepsis/abscess at surgery
  • Previous trans-abdominal pelvic surgery
  • Urethral catheter required for urine output monitoring beyond 24 hours post-operatively
  • Presence of enterovesical fistula
  • Pre-operative use of medications which alter detrusor function
  • Pregnancy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Ireland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01508767
Other Study ID Numbers  ICMJE Joyce-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Myles Joyce, University College Hospital Galway
Study Sponsor  ICMJE University College Hospital Galway
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Myles R. Joyce, MB, BCh, BAO University College Hospital Galway
PRS Account University College Hospital Galway
Verification Date August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP