Trial Outcomes & Findings for Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion (NCT NCT00995020)
NCT ID: NCT00995020
Last Updated: 2015-07-10
Results Overview
Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
103 participants
Primary outcome timeframe
3 months after the surgery is performed.
Results posted on
2015-07-10
Participant Flow
Between November 1999 and December 2004, patients were assessed for eligibility, the great majority in Rio de Janeiro.
127 women were eligible for both arms: 5 refused to participate, 19 did not meet inclusion criteria.
Participant milestones
| Measure |
SWETZ - Straight Wire Excision of the Transformation Zone
The experimental intervention was SWETZ (straight wire excision of the transformation zone), 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: Large Loop Excision of Transformation Zone - Cone
The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), 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 (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium.
|
|---|---|---|
|
Overall Study
STARTED
|
51
|
52
|
|
Overall Study
COMPLETED
|
48
|
45
|
|
Overall Study
NOT COMPLETED
|
3
|
7
|
Reasons for withdrawal
| Measure |
SWETZ - Straight Wire Excision of the Transformation Zone
The experimental intervention was SWETZ (straight wire excision of the transformation zone), 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: Large Loop Excision of Transformation Zone - Cone
The standard procedure, LLETZ - cone (large loop excision of tranformation zone used as cone biopsy), 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 (transformation zone) and brought slowly to just outside the controlateral transformation zone margin with the ambition of removing 20-25 mm length of endocervical epithelium.
|
|---|---|---|
|
Overall Study
margin analysis not performed
|
2
|
5
|
|
Overall Study
specimen fragmentation, thermal damage
|
1
|
2
|
Baseline Characteristics
Efficacy Study of Diathermy Cone Biopsy for the Treatment of Cervical Intraepithelial Lesion
Baseline characteristics by cohort
| Measure |
SWETZ - Straight Wire Excision of the Transformation Zone
n=51 Participants
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
n=52 Participants
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
n=103 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.7 years
STANDARD_DEVIATION 9.9 • n=93 Participants
|
45.6 years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
44.6 years
STANDARD_DEVIATION 10.6 • n=27 Participants
|
|
Sex: Female, Male
Female
|
51 Participants
n=93 Participants
|
52 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Region of Enrollment
Brazil
|
46 participants
n=93 Participants
|
46 participants
n=4 Participants
|
92 participants
n=27 Participants
|
|
Region of Enrollment
Ireland
|
5 participants
n=93 Participants
|
6 participants
n=4 Participants
|
11 participants
n=27 Participants
|
PRIMARY outcome
Timeframe: 3 months after the surgery is performed.Population: All data were analysed bu intention to treat.
Primary outcome is the number of participants with incomplete excision of dysplasia at the endocervical excision margin as recognized histologically.
Outcome measures
| Measure |
SWETZ
n=51 Participants
SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
|
LLETZ Cone
n=52 Participants
LLETZ cone,the standard procedure 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.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
|
|---|---|---|
|
Endocervical Margin Not Free of Disease.
|
8 participants
|
10 participants
|
SECONDARY outcome
Timeframe: Time spent from randomization to complete the procedureTime was recorded from insertion until removal of the vaginal speculum.
Outcome measures
| Measure |
SWETZ
n=52 Participants
SWETZ (Straight wire excision of the transformation zone), the experimental intervention, is a cone biopsy procedure that uses a 1cm X 0.20mm straight wire to fashion a cone excision,with the ambition of removing 20-25 mm length of endocervical epithelium. Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
|
LLETZ Cone
n=51 Participants
LLETZ cone,the standard procedure 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.Cone biopsy is a surgical procedure which objectives the excision of the pre-invasive disease located at endocervical transformation zone or glandular epithelium of the cervix. This procedure removes the cervical pre-invasive disease for the woman under this condition.
|
|---|---|---|
|
Time Spent to Perform the Procedure
|
13.5 minuts
Standard Deviation 5.3
|
23.2 minuts
Standard Deviation 8.1
|
Adverse Events
SWETZ - Straight Wire Excision of the Transformation Zone
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LLETZ Cone - Loop Excision of TZ Cone Biopsy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Investigator: MJCamargo [Camargo Maria José] Official Title: PHD
Affiliation: Oswaldo Cruz Foundation
Phone: 00552199777009
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place