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

NCT01508767 | Completed

• 1 other identifier: Joyce-2011
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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 Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.

Conditions

Urinary Retention

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Symptomatic bacteruria

  Within 14 days of urethral catheter removal

• Pulmonary complications

  For the first 14 days post-operatively

• Surgical site infection

  Within 7 days post-operatively

Study Arms (2)

Study group 1

EXPERIMENTAL

Early removal of urethral catheter 48 hours post-operatively.

Other: Removal of urethral catheter

Study group 2

OTHER

Removal of urethral catheter once epidural analgesia has been withdrawn.

Other: Removal of urethral catheter

Interventions

Removal of urethral catheter OTHER

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.

Also known as: Urethral catheter, Indwelling Urinary catheter, Indwelling urethral catheter

Study group 1; Study group 2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University College Hospital Galway: lead

Study Sites (1)

University College Hospital Galway

Galway, Co. Galway, Ireland

Location

Related Publications (2)

• 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.

  PMID: 34184246 DERIVED

• 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.

  PMID: 25769395 DERIVED

MeSH Terms

Conditions

Urinary Retention

Interventions

Urinary Catheters

Condition Hierarchy (Ancestors)

Urination Disorders; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Catheters; Equipment and Supplies

Study Officials

• Myles R. Joyce, MB, BCh, BAO

  University College Hospital Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant colorectal and general surgeon

Study Record Dates

• First Submitted: January 4, 2012
• First Posted: January 12, 2012
• Study Start: January 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: August 19, 2013

Record last verified: 2013-08

Locations

IE (1)