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

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

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.

Study Overview

• Status: Completed
• Conditions: Stenosis Cervix
• Intervention / Treatment: Device: DUDA device; Procedure: LEEP

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 Type: Interventional
• Enrollment (Actual): 265
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • São Paulo
    • Barretos, São Paulo, Brazil, 14784400
      • Barretos Cancer Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 months
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	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	6 months
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.	30 days
View of the squamo-columnar junction (SCJ) of the cervix	It will be assessed during the examination of colposcopy	6 months

Collaborators and Investigators

• Sponsor: Barretos Cancer Hospital
• Investigators: Study Director: Ricardo Reis, PHD, Director of the Teaching and Research Institute - Barretos Cancer Hospital

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): June 1, 2018
• Study Completion (Actual): January 7, 2019

Study Registration Dates

• First Submitted: July 15, 2015
• First Submitted That Met QC Criteria: July 16, 2015
• First Posted (Estimate): July 17, 2015

Study Record Updates

• Last Update Posted (Actual): January 18, 2020
• Last Update Submitted That Met QC Criteria: January 14, 2020
• Last Verified: June 1, 2018

More Information

Terms related to this study

• Keywords: Cervical Intraepithelial Neoplasia; medical device; conization; stenosis; cervix; inventories; Uterine Cervix; Intrauterine Devices; intrauterine; loop electrosurgical excision
• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Carcinoma; Neoplasms, Glandular and Epithelial; Uterine Cervical Diseases; Uterine Diseases; Pathological Conditions, Anatomical; Precancerous Conditions; Carcinoma in Situ; Cervical Intraepithelial Neoplasia; Constriction, Pathologic; Uterine Cervical Dysplasia
• Other Study ID Numbers: BarretosCH - DUDA