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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
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cervical Cancer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

    First Posted
    June 5, 2018
    Last Updated
    June 16, 2018
    Sponsor
    Barretos Cancer Hospital
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    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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