NCT01186237

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable colorectal-cancer

Timeline
Completed

Started Jun 2010

Typical duration for not_applicable colorectal-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2010

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 23, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2012

Completed
Last Updated

March 22, 2021

Status Verified

March 1, 2021

Enrollment Period

2.5 years

First QC Date

August 9, 2010

Last Update Submit

March 17, 2021

Conditions

Colorectal Cancer

Keywords

Colon/Rectal Cancer Rectal CancerQuality of Life

Outcome Measures

Primary Outcomes (1)

  • urinary retention

    6 months

Study Arms (1)

Early urinary catheter removal

EXPERIMENTAL
Procedure: Early urinary catheter removal

Interventions

Early urinary catheter removalPROCEDURE

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

Early urinary catheter removal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients at Stanford Hospital undergoing:
  • anterior resection
  • sigmoid colectomy
  • low anterior resection
  • abdomino-perineal resection
  • total proctocolectomy with ileal pouch-analanastomosis
  • coloanalanastomosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stanford University School of Medicine

Stanford, California, 94305, United States

Location

MeSH Terms

Conditions

Colorectal NeoplasmsRectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Study Officials

  • Mark Lane Welton

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 9, 2010

First Posted

August 23, 2010

Study Start

June 1, 2010

Primary Completion

December 1, 2012

Study Completion

December 1, 2012

Last Updated

March 22, 2021

Record last verified: 2021-03

Locations

US(1)