How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia? (DUDA)

Barretos Cancer Hospital

Status: Completed

Conditions: Stenosis Cervix

Treatments: Device: DUDA device; Procedure: LEEP

Study type: Interventional

Funder types: Other

Identifiers

NCT02500966

BarretosCH - DUDA

Details and patient eligibility

About

Cervical stenosis may occur in up to 19% after conization. It is a cause of infertility and amenorrhea. This study will test a new device named DUDA Device ("Dispositivo Uterino para dilatar canal endocervical") placed just after the conization, in order to evaluate the safety, efficacy and quality of life.

Full description

This device has the potential to improve outcomes by means of a significant stenosis reduction and maintain patency of the endocervical canal to view the squamo-columnar junction (SCJ) of the cervix during follow-up of this patient.

Enrollment: 265 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• High Grade Cervical Dysplasia, Grades 2 and 3, in the biopsy cervical
• 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

• Pregnancy
• 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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265 participants in 2 patient groups

DUDA device

Experimental group

Description:

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.)

Treatment:

Device: DUDA device

Procedure: LEEP

Control group

Active Comparator group

Description:

The number of patients to be recruited in this arm will be 120. Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device

Treatment:

Procedure: LEEP