How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?
NCT ID: NCT02500966
Last Updated: 2020-01-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
265 participants
INTERVENTIONAL
2015-08-31
2019-01-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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DUDA device
The number of patients to be recruited in this arm will be 145. Note: The first twenty-five patients who will be included in the study will be allocated in the intervention arm to safety analysis (phase 1); after that all eligible candidates will be randomized 1:1 (phase 2).
Procedure: Loop Electrosurgical Excision Procedure (LEEP) followed by implantation of the device called DUDA (plastic device developed in barretos cancer hospital that will be placed after conization. It has 2.5 cm in length and 5mm in diameter and remains within the endocervical canal for 30 days and is set at 4 points with nonabsorbable sutures in the ectocervix.)
DUDA device
Insertion DUDA device
LEEP
Loop Electrosurgical Excision Procedure
Control group
The number of patients to be recruited in this arm will be 120.
Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device
LEEP
Loop Electrosurgical Excision Procedure
Interventions
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DUDA device
Insertion DUDA device
LEEP
Loop Electrosurgical Excision Procedure
Eligibility Criteria
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Inclusion Criteria
* Patient eligible for conization
* Patient must consent for the appropriate surgery
* Patient must have Gynecologic Oncology Group (GOG) performance status of 0, 1
* Patients must have signed an approved informed consent and authorization permitting release of personal health information
Exclusion Criteria
* Previous conization
* limited comprehension of the study
* the risk of the American Society of Anesthesiologists, III or IV
* HIV or immunodepression
* Patients with a history of the invasive malignancies
18 Years
65 Years
FEMALE
No
Sponsors
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Barretos Cancer Hospital
OTHER
Responsible Party
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Principal Investigators
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Ricardo Reis, PHD
Role: STUDY_DIRECTOR
Director of the Teaching and Research Institute - Barretos Cancer Hospital
Locations
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Barretos Cancer Hospital
Barretos, São Paulo, Brazil
Countries
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Other Identifiers
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BarretosCH - DUDA
Identifier Type: -
Identifier Source: org_study_id
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