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

Not Applicable

Completed

• Conditions: Stenosis Cervix

• Registration Number: NCT02500966
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2015-07-15
• Study First Submitted QC: 2015-07-16
• Study First Posted: 2015-07-17
• Study Start: 2015-08
• Status Verified: 2018-06
• Primary Completion: 2018-06
• Study Completion: 2019-01-07
• Last Update Submitted: 2020-01-14
• Last Update Posted: 2020-01-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 265

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Barretos Cancer Hospital; 🇧🇷 Barretos, São Paulo, Brazil