Diathermy Cone Biopsy - A Randomized Controlled Trial of Two Techniques

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MJCamargo, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT01733225
First received: November 20, 2012
Last updated: November 24, 2012
Last verified: November 2012
  Purpose

This is an open randomized controlled trial with the purpose fo comparing two techniques of cervical cone biopsy, large loop excision of transformation zone cone (LLETZ cone) versus straight wire excision of transformation zone (SWETZ) in the treatment of Cervical Intraepithelial Neoplasia (CIN).


Condition Intervention
Cervical Intraepithelial Neoplasia
Procedure: LLETZ CONE (large loop excision of transformation zone cone)
Procedure: SWETZ (Straight wire excision of transformation zone)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CONE BIOPSY: LLETZ CONE vs SWETZ FOR WOMEN WITH CERVICAL PRE-INVASIVE DISEASE. A Randomised Controlled Trial.

Resource links provided by NLM:


Further study details as provided by Oswaldo Cruz Foundation:

Primary Outcome Measures:
  • Histological recognized dysplasia at the endocervical margin. [ Time Frame: Two months ] [ Designated as safety issue: No ]

Enrollment: 103
Study Start Date: November 1999
Study Completion Date: March 2012
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: LLETZ cone
The standard procedure, LLETZ - cone (large loop excision of transformation zone - cone) is performed with a large loop electrode of 20-25 mm depth. The activated loop is applied to the cervix outside the lateral margin of TZ and brought slowly to just outside the controlateral TZ margin with the ambition of removing 20-25 mm length of endocervical epithelium.
Procedure: LLETZ CONE (large loop excision of transformation zone cone)
Experimental: SWETZ: Straight wire excision of transformation zone
SWETZ (straight wire excision of transformation zone) is an electrosurgical technique wich uses a 1cm straight 0.20mm wire to fashion a cone, with the ambition of removing 20-25 mm length of endocervical epithelium.
Procedure: SWETZ (Straight wire excision of transformation zone)

Detailed Description:

Women with the indication to a cone biopsy were randomized to undergo to a LLETZ cone, or SWETZ. A large loop electrode of 20-25 mm depth and a 1cm straight wire electrode were used. The aim was to remove the endocervical epithelium dysplasia completely.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • HSIL in a type 3 TZ (endocervical transformation zone)
  • Suspicion of micro-invasive or invasive carcinoma
  • Suspicion of glandular disease

Exclusion Criteria:

  • Pregnancy
  • Cervicitis
  • Coagulation disorders
  • Refusal to participate in the study
  Contacts and Locations
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No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: MJCamargo, PhD, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01733225     History of Changes
Other Study ID Numbers: CONEP 522/99
Study First Received: November 20, 2012
Last Updated: November 24, 2012
Health Authority: Brazil: Ministry of Health

Keywords provided by Oswaldo Cruz Foundation:
Conization
Cervical Intraepithelial Neoplasia
Cervix Dysplasia
Therapy
Electrosurgery

Additional relevant MeSH terms:
Cervical Intraepithelial Neoplasia
Carcinoma in Situ
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on September 29, 2014