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

NCT02500966 | Completed DMC

• 1 other identifier: BarretosCH - DUDA
• Study Type: interventional
• Target: 265
• Locations: 1 country
• Sites: 1

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.

Conditions

Stenosis Cervix

Keywords

Cervical Intraepithelial Neoplasia; stenosis; cervix; medical device; inventories; Uterine Cervix; Intrauterine Devices; intrauterine; conization; loop electrosurgical excision

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Pain Scales

  6 months

• Complications

  30 days

• View of the squamo-columnar junction (SCJ) of the cervix

  6 months

Study Arms (2)

DUDA device

EXPERIMENTAL

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; Procedure: LEEP

Control group

ACTIVE COMPARATOR

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

Procedure: LEEP

Interventions

DUDA device DEVICE

Insertion DUDA device

DUDA device

LEEP PROCEDURE

Loop Electrosurgical Excision Procedure

Control group; DUDA device

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Barretos Cancer Hospital: lead

Study Sites (1)

Barretos Cancer Hospital

Barretos, São Paulo, 14784400, Brazil

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia; Constriction, Pathologic

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Ricardo Reis, PHD

  Director of the Teaching and Research Institute - Barretos Cancer Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 17, 2015
• Study Start: August 1, 2015
• Primary Completion: June 1, 2018
• Study Completion: January 7, 2019
• Last Updated: January 18, 2020

Record last verified: 2018-06

Locations

BR (1)