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

Conditions

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
Procedure: REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY
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

Barretos Cancer Hospital

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.

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