Phase 3
N=164
A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins
Cervical Intraepithelial Neoplasia
Bottom Line
View on ClinicalTrials.gov: NCT01929993 ↗Enrolled (actual)
164
Serious AEs
1.3%
Results posted
Jun 2015
Primary outcome: Primary: The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. — 28; 39 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- SWETZ (Procedure); LLETZ cone (Procedure)
- Age
- Pediatric, Adult, Older Adult
- Sex
- Female
- Sponsor
- Oswaldo Cruz Foundation
- Primary completion
- Dec 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. |
28; 39 | — |
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.
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01929993). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.