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

Primary Purpose

Stenosis Cervix

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
DUDA device
LEEP
Sponsored by
Barretos Cancer Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Stenosis Cervix focused on measuring Cervical Intraepithelial Neoplasia, stenosis, cervix, medical device, inventories, Uterine Cervix, Intrauterine Devices, intrauterine, conization, loop electrosurgical excision

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

  • Barretos Cancer Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DUDA device

Control group

Arm 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.)

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

Outcomes

Primary Outcome Measures

Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5)
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.
Cervical stenosis
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

Pain Scales
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).
Complications
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.
View of the squamo-columnar junction (SCJ) of the cervix
It will be assessed during the examination of colposcopy

Full Information

First Posted
July 15, 2015
Last Updated
January 14, 2020
Sponsor
Barretos Cancer Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02500966
Brief Title
How to Avoid Cervical Stenosis After LEEP in High Grade Cervical Dysplasia?
Acronym
DUDA
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 Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2018 (Actual)
Study Completion Date
January 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Barretos Cancer Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stenosis Cervix
Keywords
Cervical Intraepithelial Neoplasia, stenosis, cervix, medical device, inventories, Uterine Cervix, Intrauterine Devices, intrauterine, conization, loop electrosurgical excision

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
265 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DUDA device
Arm Type
Experimental
Arm 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.)
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
The number of patients to be recruited in this arm will be 120. Procedure: Loop Electrosurgical Excision Procedure (LEEP) without DUDA device
Intervention Type
Device
Intervention Name(s)
DUDA device
Intervention Description
Insertion DUDA device
Intervention Type
Procedure
Intervention Name(s)
LEEP
Intervention Description
Loop Electrosurgical Excision Procedure
Primary Outcome Measure Information:
Title
Safety (two adverse events Grade 3 or 4 (CTCAE v. 4.0) or a single adverse event Grade 5)
Description
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.
Time Frame
3 months
Title
Cervical stenosis
Description
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
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Pain Scales
Description
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).
Time Frame
6 months
Title
Complications
Description
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.
Time Frame
30 days
Title
View of the squamo-columnar junction (SCJ) of the cervix
Description
It will be assessed during the examination of colposcopy
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Reis, PHD
Organizational Affiliation
Director of the Teaching and Research Institute - Barretos Cancer Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Barretos Cancer Hospital
City
Barretos
State/Province
São Paulo
ZIP/Postal Code
14784400
Country
Brazil

12. IPD Sharing Statement

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

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