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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02500966
Recruitment Status : Completed
First Posted : July 17, 2015
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Barretos Cancer Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Stenosis Cervix Device: DUDA device Procedure: LEEP Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 265 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomized Study to Evaluate the Safety, Efficacy and Quality of Life of a New Device to Prevent Cervical Stenosis After LEEP in High Grade Cervical Dysplasia
Study Start Date : August 2015
Actual Primary Completion Date : June 2018
Actual Study Completion Date : January 7, 2019

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Arm Intervention/treatment
Experimental: 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.)

Device: DUDA device
Insertion DUDA device

Procedure: LEEP
Loop Electrosurgical Excision Procedure

Active Comparator: Control group

The number of patients to be recruited in this arm will be 120.

Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device

Procedure: LEEP
Loop Electrosurgical Excision Procedure




Primary Outcome Measures :
  1. Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5) [ Time Frame: 3 months ]
    The main safety events to be considered in this analysis are vaginal bleeding and uterine infection. The device is considered unsafe and consequently disrupted the study if a two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5 related to the procedure/device happens during the phase 1.

  2. Cervical stenosis [ Time Frame: 6 months ]

    Stenosis of the endocervical canal (early and late) will be assessed by clinical information and physical examination at each visit to the hospital after surgery. The participant will be asked about the menstrual flow and dysmenorrhea during history taking. On physical examination, after the visualization of the cervix through the speculum examination, the doctor will check the channel permeability introducing a hysterometer through it. The difficulty of introducing the hysterometer 2.5mm the channel will be scored according to the following scale:

    Possible passage of hysterometer? () No difficulty () Little difficult, however possible passage of hysterometer () Unable to pass



Secondary Outcome Measures :
  1. Pain Scales [ Time Frame: 6 months ]
    The quality of life will be evaluated through questionnaires by the Functional Assessment of Cancer Therapy - Cervix Cancer (FACT-Cx) and the universal pain assessment tools that include international scale and pain visual analogue (EVA), numerical visual pain scale (EVN) and faces pain scales (EF).

  2. Complications [ Time Frame: 30 days ]
    It will be evaluated during the following returns and described as any event related directly to the use of DUDA device as metrorrhagia and uterine infection.

  3. View of the squamo-columnar junction (SCJ) of the cervix [ Time Frame: 6 months ]
    It will be assessed during the examination of colposcopy



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02500966


Locations
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Brazil
Barretos Cancer Hospital
Barretos, São Paulo, Brazil, 14784400
Sponsors and Collaborators
Barretos Cancer Hospital
Investigators
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Study Director: Ricardo Reis, PHD Director of the Teaching and Research Institute - Barretos Cancer Hospital
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Responsible Party: Barretos Cancer Hospital
ClinicalTrials.gov Identifier: NCT02500966    
Other Study ID Numbers: BarretosCH - DUDA
First Posted: July 17, 2015    Key Record Dates
Last Update Posted: January 18, 2020
Last Verified: June 2018
Keywords provided by Barretos Cancer Hospital:
Cervical Intraepithelial Neoplasia
stenosis
cervix
medical device
inventories
Uterine Cervix
Intrauterine Devices
intrauterine
conization
loop electrosurgical excision
Additional relevant MeSH terms:
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Uterine Cervical Dysplasia
Cervical Intraepithelial Neoplasia
Constriction, Pathologic
Pathological Conditions, Anatomical
Precancerous Conditions
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type