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临床试验/NCT03570593
NCT03570593已完成不适用

Evaluation of Early Removal of Urinary Catheter After Radical Surgery for Cervical Cancer Treatment

Barretos Cancer Hospital0 个研究点目标入组 95 人开始时间: 2014年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
95
主要终点
Urinary retention

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

性别
Female
接受健康志愿者

入选标准

  • The inclusion criteria for this study are women with invasive cervical neoplasia treated with hysterectomy or radical trachelectomy

排除标准

  • Patients treated at another cancer service.

研究组 & 干预措施

Prospective Group

Experimental

干预措施: REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY (Procedure)

Retrospective Group

No Intervention

结局指标

主要结局

Urinary retention

时间窗: 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

次要结局

未报告次要终点

研究者

发起方
Barretos Cancer Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ricardo dos Reis

Principal Investigator

Barretos Cancer Hospital

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