Removal of Urinary Catheter After Radical Surgery

Not Applicable

Completed

• Conditions: Radical Hysterectomy; Cervical Cancer; Bladder Dysfunction
• Interventions: Procedure: REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY

• Registration Number: NCT03570593
• Lead Sponsor: Barretos Cancer Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-06-01
• Primary Completion: 2016-07-20
• Study Completion: 2017-11-20
• Status Verified: 2018-06
• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-06-16
• Last Update Submitted: 2018-06-16
• Study First Posted: 2018-06-27
• Last Update Posted: 2018-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 95

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective Group	REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY	-

Primary Outcome Measures

Name	Time	Method
Urinary retention	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