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

Sponsor

Barretos Cancer Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02500966

Collaborator

(none)

265

Enrollment

Location

Arms

41.2

Duration (Months)

6.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Stenosis Cervix	Device: DUDA device Procedure: LEEP	N/A

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.

Study Design

Study Type:

Interventional

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 :

Aug 1, 2015

Actual Primary Completion Date :

Jun 1, 2018

Actual Study Completion Date :

Jan 7, 2019

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Pain Scales [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).
Complications [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.
View of the squamo-columnar junction (SCJ) of the cervix [6 months]
It will be assessed during the examination of colposcopy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

Female

Accepts 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