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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01508767
Enrollment
41
Registered
2012-01-12
Start date
2012-01-31
Completion date
2013-07-31
Last updated
2013-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urinary Retention

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 Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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.

Interventions

OTHERRemoval 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.

Sponsors

University College Hospital Galway
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Post-operative urinary retention requiring re-catheterisation14 days following urethral catheter removalDevelopment 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

MeasureTime frameDescription
Symptomatic bacteruriaWithin 14 days of urethral catheter removalShould 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 complicationsFor the first 14 days post-operativelyThe development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.
Surgical site infectionWithin 7 days post-operativelyThe development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026