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

NCT ID: NCT01508767

Last Updated: 2013-08-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 41 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2013-07-31

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Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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

Conditions

Urinary Retention

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Study group 1

Early removal of urethral catheter 48 hours post-operatively.

Group Type: EXPERIMENTAL

Removal of urethral catheter

Intervention Type: 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.

Study group 2

Removal of urethral catheter once epidural analgesia has been withdrawn.

Group Type: OTHER

Removal of urethral catheter

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

Urethral catheter; Indwelling Urinary catheter; Indwelling urethral catheter

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University College Hospital Galway

OTHER

Sponsor Role: lead

Responsible Party

Myles Joyce

Consultant colorectal and general surgeon

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Myles R. Joyce, MB, BCh, BAO

Role: PRINCIPAL_INVESTIGATOR

University College Hospital Galway

Locations

University College Hospital Galway

Galway, Co. Galway, Ireland

Countries

Ireland

References

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.

Reference Type: DERIVED

PMID: 34184246 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 25769395 (View on PubMed)

Other Identifiers

Joyce-2011

Identifier Type: -

Identifier Source: org_study_id