Diathermy Cone Biopsy - A Randomized Controlled Trial of Two Techniques
This study has been completed.
Sponsor:
Oswaldo Cruz Foundation
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
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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
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:
|
Neoplasms Cervical Intraepithelial Neoplasia Carcinoma in Situ |
Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type |
ClinicalTrials.gov processed this record on May 16, 2013