Diathermy Cone Biopsy - A Randomized Controlled Trial of Two Techniques
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).
Cervical Intraepithelial Neoplasia
Procedure: LLETZ CONE (large loop excision of transformation zone cone)
Procedure: SWETZ (Straight wire excision of transformation zone)
|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.|
- Histological recognized dysplasia at the endocervical margin. [ Time Frame: Two months ] [ Designated as safety issue: No ]
|Study Start Date:||November 1999|
|Study Completion Date:||March 2012|
|Primary Completion Date:||December 2004 (Final data collection date for primary outcome measure)|
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)|
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.
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