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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01186237
First received: August 9, 2010
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention
Colorectal Cancer
Procedure: Early urinary catheter removal

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Early Removal of Urinary Catheters in Patients After Rectal Surgery: a Prospective Study

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • urinary retention [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: June 2010
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: 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).
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Exclusion criteria Patients with history of neurogenic bladder who had indwelling catheters or required intermittent straight catheterization prior to surgery

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01186237

Contacts
Contact: Moe Jalali, MD 650-724-4023 moej@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Moe Jalali, MD    650-724-4023    moej@stanford.edu   
Contact: Cancer Clinical Trials Office    (650) 498-7061      
Principal Investigator: Mark Lane Welton, MD         
Sub-Investigator: Kim Felder Rhoads, MD         
Sub-Investigator: Cindy Kin, MD         
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Mark Lane Welton Stanford University
  More Information

No publications provided

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01186237     History of Changes
Other Study ID Numbers: REC0004, SU-05272010-6187, 17865, NCI-2010-02350
Study First Received: August 9, 2010
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
Colon/Rectal Cancer Rectal Cancer
Quality of Life

Additional relevant MeSH terms:
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases

ClinicalTrials.gov processed this record on September 16, 2014