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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Condition Cervical Intraepithelial Neoplasia
Interventions Procedure: SWETZ
Procedure: LLETZ cone
Enrollment 164
Recruitment Details Women who needed type 3 excision of the Transformation Zone referred to a colposcopy clinic in Rio de Janeiro, Brazil, after cytological screening between January 2008 thru December 2011.
Pre-assignment Details  
Arm/Group Title Straight Wire Excision of Transformation Zone (SWETZ) Large Loop Excision of the Transformation Zone (LLETZ-cone)
Hide Arm/Group Description Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode to remove the dysplastic epithelium of the cervix. Large Loop Excision of the Transformation Zone (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.
Period Title: Overall Study
Started 82 82
Completed 52 54
Not Completed 30 28
Reason Not Completed
Protocol Violation             4             6
Absent CIN, invasion present or artifact             26             22
Arm/Group Title Straight Wire Excision of Transformation Zone (SWETZ) Large Loop Excision of the Transformation Zone (LLETZ-cone) Total
Hide Arm/Group Description Straight wire excision of transformation zone (SWETZ) is an electrosurgical conization method, which uses a straight wire electrode as a knife to remove the dysplastic epithelium of the cervix. Large loop excision of the Transformation Zone (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. Total of all reporting groups
Overall Number of Baseline Participants 52 54 106
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 54 participants 106 participants
44  (13.3) 42.3  (10.7) 43.1  (12.0)
Sex/Gender, Customized  
Measure Type: Number
Unit of measure:  Participants
Female Number Analyzed 52 participants 54 participants 106 participants
52 54 106
1.Primary Outcome
Title The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.
Hide Description Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.
Time Frame one month after the procedure
Hide Outcome Measure Data
Hide Analysis Population Description
Any compromised margin.
Arm/Group Title SWETZ LLETZ Cone
Hide Arm/Group Description:

Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.

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.

LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.

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.

Overall Number of Participants Analyzed 52 54
Measure Type: Number
Unit of Measure: participants
28 39
Time Frame Adverse events were observed during or through the first week after the procedures.
Adverse Event Reporting Description Participants at risk: the ones originally included and who received one of the procedures, no matter who had been excluded from the primary outcome analysis.
 
Arm/Group Title SWETZ LLETZ Cone
Hide Arm/Group Description

Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.

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.

LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.

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.

All-Cause Mortality
SWETZ LLETZ Cone
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
SWETZ LLETZ Cone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/81 (1.23%)      1/78 (1.28%)    
Injury, poisoning and procedural complications     
Hysterectomy * [1]  1/81 (1.23%)  1 0/78 (0.00%)  0
vaginal injury * [2]  0/81 (0.00%)  0 1/78 (1.28%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Hysterectomy due to vascular injury
[2]
Accidental opening of the vaginal mucosa up to near the muscle layer of the bladder.
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
SWETZ LLETZ Cone
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/81 (1.23%)      1/78 (1.28%)    
Injury, poisoning and procedural complications     
Needed general anesthesia * [1]  1/81 (1.23%)  1 1/78 (1.28%)  1
*
Indicates events were collected by non-systematic assessment
[1]
Needed general anesthesia due to some discomfort during the procedure.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr Fábio Russomano
Organization: Fundação Oswaldo Cruz
Phone: 55 21 25541815
EMail: fabiorussomano@gmail.com
Layout table for additonal information
Responsible Party: MJCamargo, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT01929993     History of Changes
Other Study ID Numbers: 522/12
First Submitted: June 10, 2012
First Posted: August 28, 2013
Results First Submitted: May 24, 2015
Results First Posted: June 9, 2015
Last Update Posted: July 23, 2015