NCT00817141

Brief Summary

Urinary catheter was placed during several days after colonic surgery. Nevertheless, it is probably unnecessary after Fast-Track colonic surgery. No prospective data permit to confirm it.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2008

Shorter than P25 for all trials

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

March 1, 2008

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

January 5, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 6, 2009

Completed
Last Updated

March 27, 2017

Status Verified

March 1, 2017

Enrollment Period

7 months

First QC Date

January 5, 2009

Last Update Submit

March 23, 2017

Conditions

Urinary Complications

Outcome Measures

Primary Outcomes (1)

  • Incidence of urinary retention necessitating catheterisation

    72 hours

Secondary Outcomes (1)

  • Other urinary complications and modification of the Fast Track protocol

    4 days

Study Arms (1)

Without urinary catheter

Other: Observational study, no intervention

Interventions

Observational study, no interventionOTHER

Observation of the complications seen without urinary catheter (which is the habitual protocol in our institution)

Without urinary catheter

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients scheduled for Fast Track colonic surgery

You may qualify if:

  • Patients scheduled for Fast Track colonic surgery

You may not qualify if:

  • Urinary pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Luc Hospital

Brussels, 1200, Belgium

Location

MeSH Terms

Interventions

Observation

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD

Study Record Dates

First Submitted

January 5, 2009

First Posted

January 6, 2009

Study Start

March 1, 2008

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

March 27, 2017

Record last verified: 2017-03

Locations

BE(1)