Removal of Urinary Catheter After Radical Surgery

NCT03570593 | Completed DMC

• 1 other identifier: Barretos Cancer Hospital
• Study Type: interventional
• Target: 95
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Cervical Cancer; Radical Hysterectomy; Bladder Dysfunction

Outcome Measures

Primary Outcomes (1)

• Urinary retention

  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

Study Arms (2)

Retrospective Group

NO INTERVENTION

Prospective Group

EXPERIMENTAL

Procedure: REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY

Interventions

REMOVAL OF URINARY CATHETER AFTER RADICAL SURGERY PROCEDURE

Removal of urinary catheter on the first day after radical surgery

Prospective Group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients treated at another cancer service.

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: June 27, 2018
• Study Start: June 1, 2014
• Primary Completion: July 20, 2016
• Study Completion: November 20, 2017
• Last Updated: June 27, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share