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Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
MJCamargo, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier:
NCT00995020
First received: June 16, 2009
Last updated: October 15, 2012
Last verified: October 2012
History of Changes
Results First Received: October 15, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Condition: Cervical Intraepithelial Neoplasia
Interventions: Procedure: Straight Wire Excision of Transformation Zone
Procedure: Large Loop Excision of Transformation Zone (cone biopsy)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Between November 1999 and December 2004, patients were assessed for eligibility, the great majority in Rio de Janeiro.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
127 women were eligible for both arms: 5 refused to participate, 19 did not meet inclusion criteria.

Reporting Groups
  Description
SWETZ - Straight Wire Excision of the Transformation Zone The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
LLETZ Cone - Loop Excision of TZ Cone Biopsy The standard procedure, LLETZ - cone, was 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.

Participant Flow:   Overall Study
    SWETZ - Straight Wire Excision of the Transformation Zone     LLETZ Cone - Loop Excision of TZ Cone Biopsy  
STARTED     51     52  
COMPLETED     48 [1]   45 [1]
NOT COMPLETED     3     7  
fragmentation, thermal damage                 2                 5  
difficulties for histological analisys                 1                 2  
[1]

Reasons for not completed:

margin analisys not performed specimen fragmentation thermal damage



  Baseline Characteristics
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Reporting Groups
  Description
SWETZ - Straight Wire Excision of the Transformation Zone The experimental intervention was SWETZ, which uses a 1cm straight wire electrode to perform a cone. The activated electrode is applied for shaping a cone with the ambition of removing 20-25 mm length of endocervical epithelium.
LLETZ Cone - Loop Excision of TZ Cone Biopsy The standard procedure, LLETZ - cone, was 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.
Total Total of all reporting groups

Baseline Measures
    SWETZ - Straight Wire Excision of the Transformation Zone     LLETZ Cone - Loop Excision of TZ Cone Biopsy     Total  
Number of Participants  
[units: participants]
 		  51     52     103  
Age  
[units: years]
Mean ± Standard Deviation 		  43.7  ± 9.9     45.6  ± 11.5     44.6  ± 10.6  
Gender  
[units: participants]
 		     
Female     51     52     103  
Male     0     0     0  
Gender  
[units: participants]
 		     
Female     51     52     103  
Male     0     0     0  
Region of Enrollment  
[units: participants]
 		     
Brazil     46     46     92  
Ireland     5     6     11  



  Outcome Measures
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1.  Primary:   Endocervical Margin Not Free of Disease.   [ Time Frame: 3 months after the surgery is performed. ]
  Show Outcome Measure 1

2.  Secondary:   Time Spent to Perform the Procedure   [ Time Frame: Time spent from randomization to complete the procedure ]
  Show Outcome Measure 2


  Serious Adverse Events
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  Other Adverse Events
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Limitations and Caveats
Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.  


Results Point of Contact:  
Name/Title: Investigator: MJCamargo [Camargo Maria José] Official Title: PHD
Organization: Affiliation: Oswaldo Cruz Foundation
phone: 00552199777009
e-mail: mariaj.camargo@hotmail.com


No publications provided


Responsible Party: MJCamargo, Oswaldo Cruz Foundation
ClinicalTrials.gov Identifier: NCT00995020     History of Changes
Other Study ID Numbers: 522/99
Study First Received: June 16, 2009
Results First Received: October 15, 2012
Last Updated: October 15, 2012
Health Authority: Brazil: National Committee of Ethics in Research