Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study

NCT ID: NCT01186237

Last Updated: 2021-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2012-12-31

Brief Summary

Recent national surgical quality guidelines (Surgical Care Improvement Project, National Hospital Inpatient Quality Measures)state that removal of urinary catheters should occur by post-operative day two for all surgical patients. These guidelines exclude neither patients who have undergone rectal surgery nor those with epidural analgesic catheters. The common practice among most colorectal surgeons is to leave urinary catheters in for three to five days for patients who have undergone rectal operations, due to concern for urinary retention. This study aims to explore the outcomes of following the national surgical guidelines for early urinary catheter removal, especially with regards to urinary retention and urinary tract infection.

Detailed Description

All patients undergoing anterior resection (rectosigmoid), low anterior resection, abdomino-perineal resection, total proctocolectomy with ileal pouch-anal anastomosis, sigmoid colectomy, and coloanal anastomosis will be included in the study. All patients will undergo standard pre-operative work-up prior to the operation. As part of the operative note, the level of the anastomosis must be documented.

1. All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).

2. All patients will undergo bladder ultrasound prior to catheter removal.

3. All patients will undergo bladder ultrasound by nursing staff six hours after catheter removal, and after voiding the first time after catheter removal, or if the patient experiences symptoms of urinary retention.

6. Patients who meet definition of urinary retention (>100cc post-void residual) will undergo intermittent straight catheterization every six hours or with symptoms. For those who refuse intermittent straight catheterization, a indwelling urinary catheter will be inserted and left in for 24 hours before removal.

7. For patients who have low urine output indicating under-resuscitation, indwelling catheters will be re-inserted and removed when ongoing resuscitation measures are completed.

8. For patients who are actively undergoing fluid resuscitation on post-operative day 3 will not have their urinary catheters removed until resuscitation and monitoring is complete.

9. Patients who report symptoms of benign prostatic hypertrophy (BPH) and/or are already on medications for BPH will be continued on those medications starting on post-operative day 1.

10. Patients who have persistent urinary retention when they are otherwise ready to be discharged home will be sent home with a leg bag and follow up in urology clinic for voiding trial in 1-2 weeks.

11. Urinalysis/urine culture will be performed for symptomatic patients.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Early urinary catheter removal

Group Type: EXPERIMENTAL

Early urinary catheter removal

Intervention Type: PROCEDURE

All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).

Interventions

Early urinary catheter removal

All patients will have foley catheters removed between 0600 and midnight of post-operative day 3 (Day 0 being the day of operation).

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

All patients at Stanford Hospital undergoing:

• anterior resection
• sigmoid colectomy
• low anterior resection
• abdomino-perineal resection
• total proctocolectomy with ileal pouch-analanastomosis
• coloanalanastomosis.

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

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mark Lane Welton

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University School of Medicine

Stanford, California, United States

Countries

United States

Other Identifiers

SU-05272010-6187

Identifier Type: OTHER

Identifier Source: secondary_id

17865

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-2010-02350

Identifier Type: -

Identifier Source: secondary_id

REC0004

Identifier Type: -

Identifier Source: org_study_id