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

• Sponsor: Oswaldo Cruz Foundation (Other)
• Overall Status: Completed
• CT.gov ID: NCT01929993
• Collaborator: (none)
• Enrollment: 164
• Location: 1
• Arms: 2
• Duration (Months): 49
• Patients Per Site Per Month: 3.3

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Intraepithelial Neoplasia	Procedure: SWETZ; Procedure: LLETZ cone	Phase 3

Detailed Description

Cone biopsy is a surgical procedure which objectives the excision of endocervical pre-invasive disease located at transformation zone or glandular epithelium. Although cone biopsy is considered adequate for the treatment of endocervical dysplastic epithelium , using electrosurgery as opposed to the cold knife technique of cone biopsy has been criticized because of the perceived potential for incomplete excision of disease, thermal damage and surgical specimen fragmentation, which might increase the risk of missing early invasive cancer. Also, incomplete excision margin of disease exposes women to an increased risk of residual post-treatment disease.

The standard procedure, Large Loop Excision of the Transformation Zone (LLETZ-cone), is performed with a large loop electrode of 20-25 mm depth.

The experimental intervention is Straight Wire Excision of the Transformation Zone (SWETZ), a method of excision using a 1cm straight disposal of 0.20 wire to remove the endocervical transformation zone or glandular disease.

Both procedures were previously studied in another clinical trial(NCT00995020), but the histological analysis were inconclusive for many outcomes. SWETZ were superior to LLETZ cone to acquire complete excision of disease, with no statistical significance, probably due to the small sample size.

This study objectives a better histological analyses of the surgical specimens related to incomplete excision, thermal damage and fragmentation.

Study Design

• Study Type: Interventional
• Actual Enrollment: 164 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Large Loop Excision of Transformation Zone Cone Versus Straight Wire Excision of Transformation Zone : Histopathological Analysis of Excision Margins
• Study Start Date: Jan 1, 2008
• Actual Primary Completion Date: Dec 1, 2011
• Actual Study Completion Date: Feb 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SWETZ Straight wire excision of transformation zone is an electrosurgical conization method, which uses a straight wire electrode.	Procedure: 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.; Other Names: NETZ - Needle excision of transformation zone
Active Comparator: LLETZ cone LLETZ cone is a electrosurgical conization method, which is performed with a large loop electrode of 20 mm depth.	Procedure: 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.; Other Names: LEEP - Loop electrosurgical excision procedure.

Outcome Measures

Primary Outcome Measures

1. The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically. [one month after the procedure]

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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Fernandes Figueira Institute - Oswaldo Cruz Foundation	Rio de Janeiro	RJ	Brazil	22250-020

Sponsors and Collaborators

• Oswaldo Cruz Foundation

Investigators

• Study Director: Maria J Camargo, PHD, Oswaldo Cruz Foundation

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: MJCamargo, PHD, Oswaldo Cruz Foundation
• ClinicalTrials.gov Identifier: NCT01929993
• Other Study ID Numbers: 522/12
• First Posted: Aug 28, 2013
• Last Update Posted: Jul 23, 2015
• Last Verified: Jun 1, 2015

• Keywords provided by MJCamargo, PHD, Oswaldo Cruz Foundation: Conization; Cervical Intraepithelial Neoplasia; Cervix Dysplasia; Therapy; Electrosurgery
• Additional relevant MeSH terms: Neoplasms; Cervical Intraepithelial Neoplasia

Study Results

Participant Flow

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.

Arm/Group Title	Straight Wire Excision of Transformation Zone (SWETZ)	Large Loop Excision of the Transformation Zone (LLETZ-cone)
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

Baseline Characteristics

Arm/Group Title	Straight Wire Excision of Transformation Zone (SWETZ)	Large Loop Excision of the Transformation Zone (LLETZ-cone)	Total
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 Participants	52	54	106
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	44 (13.3)	42.3 (10.7)	43.1 (12.0)
Sex/Gender, Customized (participants) [Number]
Female	52 100%	54 100%	106 100%

Outcome Measures

1. Primary Outcome

Title	The Prevalence of Incomplete Excision of Dysplasia at the Endocervical Excision Margin as Recognized Histologically.
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

Outcome Measure Data

Analysis Population Description

Any compromised margin.

Arm/Group Title	SWETZ	LLETZ Cone
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.
Measure Participants	52	54
Number [participants]	28 53.8%	39 72.2%

Adverse Events

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
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 (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	SWETZ		LLETZ Cone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/81 (1.2%)		1/78 (1.3%)
Injury, poisoning and procedural complications
Hysterectomy	1/81 (1.2%)	1	0/78 (0%)	0
vaginal injury	0/81 (0%)	0	1/78 (1.3%)	1
Other (Not Including Serious) Adverse Events
	SWETZ		LLETZ Cone
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/81 (1.2%)		1/78 (1.3%)
Injury, poisoning and procedural complications
Needed general anesthesia	1/81 (1.2%)	1	1/78 (1.3%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.