Clinical trial NCT01508767: Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Official title: Prospective Randomized Controlled Trial of Early Post-operative Removal of Urethral Catheter in Patients Undergoing Colorectal Surgery With Epidural Analgesia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Urinary Retention
Lead sponsor: University College Hospital Galway
Sponsor class: OTHER
First posted: 2012-01-12
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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

Eligibility 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

Primary outcomes:
measure: Post-operative urinary retention requiring re-catheterisation
timeFrame: 14 days following urethral catheter removal
Secondary outcomes:
measure: Symptomatic bacteruria
timeFrame: Within 14 days of urethral catheter removal
measure: Pulmonary complications
timeFrame: For the first 14 days post-operatively
measure: Surgical site infection
timeFrame: Within 7 days post-operatively
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: University College Hospital Galway
state: Co. Galway
Study officials:
affiliation: University College Hospital Galway
name: Myles R. Joyce, MB, BCh, BAO
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ellahi A, Stewart F, Kidd EA, Griffiths R, Fernandez R, Omar MI. Strategies for the removal of short-term indwelling urethral catheters in adults. Cochrane Database Syst Rev. 2021 Jun 29;6(6):CD004011. doi: 10.1002/14651858.CD004011.pub4.
citation: 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.