NCT03570593

Removal of Urinary Catheter After Radical Surgery

Completed NA Last updated 27 June 2018

What this trial tests

NA trial testing REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY in Cervical Cancer in 95 participants. Completed in 20 November 2017.

Timeline

1 June 2014

Primary endpoint
20 July 2016

20 November 2017

Quick facts

Lead sponsor	Barretos Cancer Hospital
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	single
Primary purpose	other
Enrollment	95
Start date	1 June 2014
Primary completion	20 July 2016
Estimated completion	20 November 2017

Drugs / interventions tested

• REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY

Conditions studied

• Cervical Cancer — all drugs for Cervical Cancer →
• Radical Hysterectomy — all drugs for Radical Hysterectomy →
• Bladder Dysfunction — all drugs for Bladder Dysfunction →

Sponsor

Barretos Cancer Hospital

Who can join

Eligibility, female only, with Cervical Cancer or Radical Hysterectomy. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.