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

Urinary Retention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01508767
• Other study ID #: Joyce-2011
• Status: Completed
• Phase: N/A
• First received: January 4, 2012
• Last updated: August 16, 2013
• Start date: January 2012
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: University College Hospital Galway
• Contact: n/a
• Is FDA regulated: No
• Health authority: Republic of Ireland: Department of health and children
• Study type: Interventional

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Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.

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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urinary Retention

Intervention

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.

Locations

Country	Name	City	State
Ireland	University College Hospital Galway	Galway	Co. Galway

Sponsors (1)

Lead Sponsor	Collaborator
University College Hospital Galway

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Post-operative urinary retention requiring re-catheterisation	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.	14 days following urethral catheter removal	No
Secondary	Symptomatic bacteruria	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.	Within 14 days of urethral catheter removal	No
Secondary	Pulmonary complications	The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.	For the first 14 days post-operatively	No
Secondary	Surgical site infection	The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.	Within 7 days post-operatively	No