Back to resultsLLETZ Under Direct Colposcopic Vision
Primary Purpose
Uterine Cervical Dysplasia
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
LLETZ with colposcopy
LLETZ without colposcopy
Sponsored by
About this trial
This is an interventional treatment trial for Uterine Cervical Dysplasia focused on measuring conization, LLETZ, loop excision, randomized controlled trial, colposcopy, direct colposcopic vision, intraoperative colposcopy
Eligibility Criteria
Inclusion Criteria:
- histologically proven cervical dysplasia
- colposcopy Prior to conization
- informed consent
Exclusion Criteria:
- significant language barrier
- a personal history of conization
- pregnancy
- the use of blood thinner
- unwillingness to participate
Sites / Locations
- Department of Obstetrics and Gynecology of the Ruhr University Bochum
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
LLETZ with colposcopy
LLETZ without colposcopy
Arm Description
The LLETZ procedure will be performed under direct colposcopic vision
The LLETZ procedure will be performed without colposcopy
Outcomes
Primary Outcome Measures
the resected cone mass
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
Secondary Outcome Measures
Margin status
Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist
Operation time
the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes
Operative complications
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
number of fragments of the surgical specimen
surgeons will count the number of the surgical specimen (1 vs. >1)
the dimensions of the surgical specimens
The circumference, length and thickness of The surgical specimens will be measured
handling of the device
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,(ranging from 0 (,very easy') to 10 (,very difficult')
satisfaction with the device
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,satisfaction with the device' (ranging from 0 (,very satisfied') to 10 (,absolutely not satisfied')
Time to complete intraoperative hemostasis
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
Intraoperative blood loss
intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively
Full Information
NCT ID
NCT02910388
First Posted
September 15, 2016
Last Updated
May 31, 2020
Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Collaborators
Ruhr University of Bochum
1. Study Identification
Unique Protocol Identification Number
NCT02910388
Brief Title
LLETZ Under Direct Colposcopic Vision
Official Title
Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zydolab - Institute of Cytology and Immune Cytochemistry
Collaborators
Ruhr University of Bochum
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uterine Cervical Dysplasia
Keywords
conization, LLETZ, loop excision, randomized controlled trial, colposcopy, direct colposcopic vision, intraoperative colposcopy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)
8. Arms, Groups, and Interventions
Arm Title
LLETZ with colposcopy
Arm Type
Experimental
Arm Description
The LLETZ procedure will be performed under direct colposcopic vision
Arm Title
LLETZ without colposcopy
Arm Type
Active Comparator
Arm Description
The LLETZ procedure will be performed without colposcopy
Intervention Type
Device
Intervention Name(s)
LLETZ with colposcopy
Intervention Description
Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue
Intervention Type
Other
Intervention Name(s)
LLETZ without colposcopy
Intervention Description
Loop procedure without using a colposcope
Primary Outcome Measure Information:
Title
the resected cone mass
Description
the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room
Time Frame
10 minutes
Secondary Outcome Measure Information:
Title
Margin status
Description
Resection margin is judge as "R0" if abnormal cells are not found in the margin of the biopsy or "R1" if abnormal cells remain in the margin of the biopsy. The histopathological examination will be done by an Independent pathologist
Time Frame
2 Days after conization
Title
Operation time
Description
the time from the beginning of the Operation (start of the electrosurgical method) until the end of the operation (the end of hemostatic interventions) will be measured in minutes
Time Frame
20 minutes
Title
Operative complications
Description
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
Time Frame
14 days
Title
number of fragments of the surgical specimen
Description
surgeons will count the number of the surgical specimen (1 vs. >1)
Time Frame
10 minutes
Title
the dimensions of the surgical specimens
Description
The circumference, length and thickness of The surgical specimens will be measured
Time Frame
2 Days after conization
Title
handling of the device
Description
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,(ranging from 0 (,very easy') to 10 (,very difficult')
Time Frame
30 minutes
Title
satisfaction with the device
Description
surgeons will score their preference regarding the surgical method using an 11-step visual analogue scale (VAS) for ,satisfaction with the device' (ranging from 0 (,very satisfied') to 10 (,absolutely not satisfied')
Time Frame
30 minutes
Title
Time to complete intraoperative hemostasis
Description
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
Time Frame
120 seconds
Title
Intraoperative blood loss
Description
intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively
Time Frame
5 hours
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
histologically proven cervical dysplasia
colposcopy Prior to conization
informed consent
Exclusion Criteria:
significant language barrier
a personal history of conization
pregnancy
the use of blood thinner
unwillingness to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziad Hilal, M.D.
Organizational Affiliation
Zydolab - Institute of Cytology and Immune Cytochemistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Obstetrics and Gynecology of the Ruhr University Bochum
City
Herne
State/Province
NRW
ZIP/Postal Code
44625
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
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LLETZ Under Direct Colposcopic Vision
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