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NCT Number: NCT01508767

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

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Traditionally these catheters are not removed until the patients epidural infusion is withdrawn, as in theory to do so would predispose the patient to developing acute retention of urine due to lack of sensation when the bladder is full. The investigators hypothesis is that urinary catheters placed via the urethra can be withdrawn 48 hours after colon/rectal surgery in patients receiving epidural pain relief without a significant increase in rates of urinary retention.

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Key information

Conditions

Urinary Retention Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Male Urogenital Diseases Urination Disorders Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Hospital Galway

Galway, Co. Galway, Ireland

About this study

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Patients in study group 2 (SG2) will have their urinary catheters removed only after the epidural has been withdrawn in the post-operative period.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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Urethral catheter, Indwelling Urinary catheter, Indwelling urethral catheter

Primary outcomes

  1. Post-operative urinary retention requiring re-catheterisation

    Time frame: 14 days following urethral catheter removal

    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.

Secondary outcomes

  1. Symptomatic bacteruria

    Time frame: Within 14 days of urethral catheter removal

    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.

  2. Pulmonary complications

    Time frame: For the first 14 days post-operatively

    The development of post-operative pulmonary complications such as atelectasis, pneumonia occurring within 14 days of surgery will be considered.

  3. Surgical site infection

    Time frame: Within 7 days post-operatively

    The development of wound and other surgical site infections within 7 days of undergoing colorectal surgery will be considered.

Sponsors and collaborators

Lead sponsor

University College Hospital Galway

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Jan 12, 2012
Registry last updated
Aug 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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