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Completed

NCT Number: NCT02500966

How to Avoid 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.

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Key information

Conditions

Stenosis Cervix Constriction, Pathologic Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Neoplasms Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Precancerous Conditions Urogenital Diseases Uterine Cervical Diseases Uterine Cervical Dysplasia Uterine Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DUDA device

Device

Insertion DUDA device

LEEP

Procedure

Loop Electrosurgical Excision Procedure

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Barretos Cancer Hospital

Other

Registry information

Official study 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

Acronym: DUDA

Important dates

Study start
2015
Primary completion
2018
Study completion
2019
First posted
Jul 17, 2015
Registry last updated
Jan 18, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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