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

This study is currently recruiting participants.
Verified January 2012 by University College Hospital Galway
Sponsor:
Information provided by (Responsible Party):
Myles Joyce, University College Hospital Galway
ClinicalTrials.gov Identifier:
NCT01508767
First received: January 4, 2012
Last updated: January 9, 2012
Last verified: January 2012
History of Changes
  Purpose

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Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.


Condition Intervention
Urinary Retention
 Other: Removal of urethral catheter

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia

Further study details as provided by University College Hospital Galway:

Primary Outcome Measures:
  • Post-operative urinary retention requiring re-catheterisation [ Time Frame: 14 days following urethral catheter removal ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Symptomatic bacteruria [ Time Frame: Within 14 days of urethral catheter removal ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.


Estimated Enrollment: 72
Study Start Date: January 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Study group 1
Early removal of urethral catheter 48 hours post-operatively.
 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.
Study group 2
Removal of urethral catheter once epidural analgesia has been withdrawn.
 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508767

Contacts
Contact: David Coyle, MB, BCh, BAO +353 87 7525478 daithiocool@gmail.com
Contact: Myles R. Joyce, MB, BCh, BAO, MD +353 91 542073 myles.joyce@hse.ie

Locations
Ireland
University College Hospital Galway Recruiting
Galway, Co. Galway, Ireland
Contact: David Coyle, MB, BCh, BAO     +353877525478     daithiocool@gmail.com    
Contact: Myles R. Joyce, MB, BCh, BAO     +35391542073     myles.joyce@hse.ie    
Sponsors and Collaborators
University College Hospital Galway
Investigators
Principal Investigator: Myles R. Joyce, MB, BCh, BAO University College Hospital Galway
  More Information

No publications provided

Responsible Party: Myles Joyce, Principle investigator, University College Hospital Galway
ClinicalTrials.gov Identifier: NCT01508767     History of Changes
Other Study ID Numbers: Joyce-2011
Study First Received: January 4, 2012
Last Updated: January 9, 2012
Health Authority: Republic of Ireland: Department of health and children

Additional relevant MeSH terms:
Urinary Retention
Urination Disorders
Urologic Diseases

ClinicalTrials.gov processed this record on May 21, 2013