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A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins

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ClinicalTrials.gov Identifier: NCT01929993
Recruitment Status : Completed
First Posted : August 28, 2013
Results First Posted : June 9, 2015
Last Update Posted : July 23, 2015
Sponsor:
Information provided by (Responsible Party):
MJCamargo, Oswaldo Cruz Foundation

Tracking Information
First Submitted Date  ICMJE June 10, 2012
First Posted Date  ICMJE August 28, 2013
Results First Submitted Date  ICMJE May 24, 2015
Results First Posted Date  ICMJE June 9, 2015
Last Update Posted Date July 23, 2015
Study Start Date  ICMJE January 2008
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 30, 2015)
The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. [ Time Frame: one month after the procedure ]
Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.
Original Primary Outcome Measures  ICMJE
 (submitted: August 22, 2013)
The incidence of incomplete excision of dysplasia at the endocervical excision margin as recognized histologically. [ Time Frame: one month after the procedure ]
Change History Complete list of historical versions of study NCT01929993 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
Official Title  ICMJE Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins
Brief Summary The purpose of this trial is to evaluate if Straight Wire Excision of the Transformation Zone (SWETZ) is superior to (Large Loop Excision of the Transformation Zone) LLETZ cone in reducing the incomplete excision of disease.
Detailed Description

Cone biopsy is a surgical procedure which objectives the excision of endocervical pre-invasive disease located at transformation zone or glandular epithelium. Although cone biopsy is considered adequate for the treatment of endocervical dysplastic epithelium , using electrosurgery as opposed to the cold knife technique of cone biopsy has been criticized because of the perceived potential for incomplete excision of disease, thermal damage and surgical specimen fragmentation, which might increase the risk of missing early invasive cancer. Also, incomplete excision margin of disease exposes women to an increased risk of residual post-treatment disease.

The standard procedure, Large Loop Excision of the Transformation Zone (LLETZ-cone), is performed with a large loop electrode of 20-25 mm depth.

The experimental intervention is Straight Wire Excision of the Transformation Zone (SWETZ), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease.

Both procedures were previously studied in another clinical trial(NCT00995020), but the histological analysis were inconclusive for many outcomes. SWETZ were superior to LLETZ cone to acquire complete excision of disease, with no statistical significance, probably due to the small sample size.

This study objectives a better histological analyses of the surgical specimens related to incomplete excision, thermal damage and fragmentation.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Cervical Intraepithelial Neoplasia
Intervention  ICMJE
  • Procedure: SWETZ
    Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix.
    Other Name: NETZ - Needle excision of transformation zone
  • Procedure: LLETZ cone
    LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth. The loop is applied to the cervix outside the lateral margin of the transformation zone and brought slowly to the controlateral transformation zone margin.
    Other Name: LEEP - Loop electrosurgical excision procedure.
Study Arms  ICMJE
  • Experimental: SWETZ
    Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.
    Intervention: Procedure: SWETZ
  • Active Comparator: LLETZ cone
    LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.
    Intervention: Procedure: LLETZ cone
Publications * Russomano F, Tristao MA, Côrtes R, de Camargo MJ. A comparison between type 3 excision of the transformation zone by straight wire excision of the transformation zone (SWETZ) and large loop excision of the transformation zone (LLETZ): a randomized study. BMC Womens Health. 2015;15:12. doi: 10.1186/s12905-015-0174-5. Epub 2015 Feb 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 30, 2015)
164
Original Actual Enrollment  ICMJE
 (submitted: August 22, 2013)
103
Actual Study Completion Date  ICMJE February 2012
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Patients were eligible if the colposcopist decided that a cone biopsy was indicated.
  • Common indications for a cone biopsy included:

    • High-grade Squamous Intraepithelial Lesion in a type 3 transformation zone,
    • suspicion of micro-invasive or invasive carcinoma and
    • suspicion of glandular disease.

Exclusion Criteria:

  • Patients were excluded if pregnancy, coagulation disorders and cervicitis were present or if they refused to participate in the study.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01929993
Other Study ID Numbers  ICMJE 522/12
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MJCamargo, Oswaldo Cruz Foundation
Study Sponsor  ICMJE Oswaldo Cruz Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maria J Camargo, PHD Oswaldo Cruz Foundation
PRS Account Oswaldo Cruz Foundation
Verification Date June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP