Removal of Urinary Catheter After Radical Surgery
June 16, 2018 updated by: Ricardo dos Reis, Barretos Cancer Hospital
Evaluation of Early Removal of Urinary Catheter After Radical Surgery for Cervical Cancer Treatment
Currently, the treatment of cervical cancer in early stages is performed with a radical surgery called Radical Hysterectomy with Pelvic Lymphadenectomy.
This surgery, when indicated correctly, in early stages of this disease, has a cure rate of approximately 90% at 5 years, compared to the same Pelvic Radiotherapy.
However, it is known that most patients with early stage cervical cancer are young (average age 45) and treating these patients with radiotherapy would have a loss of hormonal function by damage to the ovaries and damage in sexual function by radiotherapy effects in the vagina.
Furthermore, if the patient has a pelvic recurrence, the option of radiotherapy treatment could not be offered.
Due to the factors listed above, nowadays, in young patients with good clinical conditions and tumors in early stages, radical surgery is a good option.
In this radical surgery there is a need for removal of the parametrium, and different degrees of pelvic denervation may occur causing damage of urinary function.Currently, there is no consensus about the correct moment of catheter removal and evaluation of urinary function using the residual urine test.
While in some services the urinary catheter is removed on day 1 postoperatively, in others it is removed on the 14th day postoperatively.
For these reasons, this study aims to compare the early catheter removal (day 1 postoperatively) versus standard in the investigator's service (7 days postoperatively) withdrawal.
If this study detect that the patients may remove the urinary catheter on day 1 postoperatively, much less cost, discomfort, pain and comorbidities associated with the use of indwelling catheter for prolonged periods occur, such as urinary tract infection, use of antibiotics and even hospitalization for this reason.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
95
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- The inclusion criteria for this study are women with invasive cervical neoplasia treated with hysterectomy or radical trachelectomy
Exclusion Criteria:
- Patients treated at another cancer service.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
No Intervention: Retrospective Group
|
|
|
Experimental: Prospective Group
|
Removal of urinary catheter on the first day after radical surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Urinary retention
Time Frame: up to 7 days after the surgery
|
Measure the urinary retention after the surgery passing an urinary catheter after patient voiding to check the urinary residual
|
up to 7 days after the surgery
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 1, 2014
Primary Completion (Actual)
July 20, 2016
Study Completion (Actual)
November 20, 2017
Study Registration Dates
First Submitted
June 5, 2018
First Submitted That Met QC Criteria
June 16, 2018
First Posted (Actual)
June 27, 2018
Study Record Updates
Last Update Posted (Actual)
June 27, 2018
Last Update Submitted That Met QC Criteria
June 16, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Barretos Cancer Hospital
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.