Removal of Urinary Catheter After Radical Surgery
Primary Purpose
Cervical Cancer, Radical Hysterectomy, Bladder Dysfunction
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY
Sponsored by
About this trial
This is an interventional other trial for Cervical Cancer
Eligibility Criteria
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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Retrospective Group
Prospective Group
Arm Description
Outcomes
Primary Outcome Measures
Urinary retention
Measure the urinary retention after the surgery passing an urinary catheter after patient voiding to check the urinary residual
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03570593
Brief Title
Removal of Urinary Catheter After Radical Surgery
Official Title
Evaluation of Early Removal of Urinary Catheter After Radical Surgery for Cervical Cancer Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
June 1, 2014 (Actual)
Primary Completion Date
July 20, 2016 (Actual)
Study Completion Date
November 20, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Barretos Cancer Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Radical Hysterectomy, Bladder Dysfunction
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
95 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Retrospective Group
Arm Type
No Intervention
Arm Title
Prospective Group
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY
Intervention Description
Removal of urinary catheter on the first day after radical surgery
Primary Outcome Measure Information:
Title
Urinary retention
Description
Measure the urinary retention after the surgery passing an urinary catheter after patient voiding to check the urinary residual
Time Frame
up to 7 days after the surgery
10. Eligibility
Sex
Female
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Removal of Urinary Catheter After Radical Surgery
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