Conization
Conditions
Interventions
This is a two-arm, single-blind, randomized controlled clinical trial. Experimental group: 233 women indicated for cervical conization will receive an Intracervical Device (under patent review) aimed
Sponsors
Fundação Oswaldo Cruz
Fundação Oswaldo Cruz
Eligibility
Sex/Gender
Female
Age
25 Years to No maximum
Inclusion criteria
Inclusion criteria: Women indicated for type III excision (conization) of the uterine cervix; women aged 25 and older
Exclusion criteria
Exclusion criteria: Women with any history of previous excisional procedures (regardless of type or timing); pregnant women; women who become pregnant within 90 days following the excisional procedure
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A 64% reduction in the risk of stenosis of the external os of the cervix is ??expected, verified by the possibility or not of introducing a brush to collect cytological material from the endocervix in 90, 180 and 360 days (and at any time until censorship). | — |
Secondary
| Measure | Time frame |
|---|---|
| Excessive bleeding measured by the woman's information that she noticed vaginal bleeding that was greater than her usual menstrual period or that required her to use more than two sanitary pads per day;Report of pain during the menstrual period in previously asymptomatic women or worsening of this symptom in those who already had it;Woman reports vaginal discharge that is different from usual;Report of unwanted vaginal odor;Report of discomfort during sexual intercourse for those who did not have it or worsening for those who already had this symptom;Request for device removal before 90 days;Other complaints reported by participants | — |
Countries
Brazil
Contacts
Public ContactMaria Camargo
Fundação Oswaldo Cruz
Outcome results
None listed