Trial Outcomes & Findings for A Trial of Two Electrosurgical Conizations: Histopathological Analysis of Excision Margins (NCT NCT01929993)

NCT ID: NCT01929993

Last Updated: 2015-07-23

Results Overview

Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 164 participants
• Primary outcome timeframe: one month after the procedure
• Results posted on: 2015-07-23

Participant Flow

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.

Participant milestones

Measure	Straight Wire Excision of Transformation Zone (SWETZ) 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) 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.
Overall Study STARTED	82	82
Overall Study COMPLETED	52	54
Overall Study NOT COMPLETED	30	28

Reasons for withdrawal

Measure	Straight Wire Excision of Transformation Zone (SWETZ) 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) 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.
Overall Study Protocol Violation	4	6
Overall Study Absent CIN, invasion present or artifact	26	22

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Straight Wire Excision of Transformation Zone (SWETZ) n=52 Participants 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) n=54 Participants 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 n=106 Participants Total of all reporting groups
Age, Continuous	44 years STANDARD_DEVIATION 13.3 • n=5 Participants	42.3 years STANDARD_DEVIATION 10.7 • n=7 Participants	43.1 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex/Gender, Customized Female	52 participants n=5 Participants	54 participants n=7 Participants	106 participants n=5 Participants

PRIMARY outcome

Timeframe: one month after the procedure

Population: Any compromised margin.

Incomplete excision was considered when high-grade intraepithelial (CIN2-3) or microinvasive neoplasia was present in the endocervical limit of the excised specimen.

Outcome measures

Measure	SWETZ n=52 Participants 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 n=54 Participants 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.
The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.	28 participants	39 participants

Adverse Events

SWETZ

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

LLETZ Cone

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Measure	SWETZ n=81 participants at risk 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 n=78 participants at risk 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.
Injury, poisoning and procedural complications Hysterectomy	1.2% 1/81 • Number of events 1 • Adverse events were observed during or through the first week after the procedures. 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.	0.00% 0/78 • Adverse events were observed during or through the first week after the procedures. 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.
Injury, poisoning and procedural complications vaginal injury	0.00% 0/81 • Adverse events were observed during or through the first week after the procedures. 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.	1.3% 1/78 • Number of events 1 • Adverse events were observed during or through the first week after the procedures. 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.

Other adverse events

Measure	SWETZ n=81 participants at risk 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 n=78 participants at risk 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.
Injury, poisoning and procedural complications Needed general anesthesia	1.2% 1/81 • Number of events 1 • Adverse events were observed during or through the first week after the procedures. 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.	1.3% 1/78 • Number of events 1 • Adverse events were observed during or through the first week after the procedures. 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.

Additional Information

Dr Fábio Russomano

Fundação Oswaldo Cruz

Phone: 55 21 25541815

Email: fabiorussomano@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place