To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
227
Loop procedure using a videocolposcope in order to see and remove the abnormal cervical tissue
Loop procedure using a binocular colposcope in order to see and remove the abnormal cervical tissue
Department of Obstetrics and Gynecology of the Ruhr University Bochum
Herne, North Rhine-Westphalia, Germany
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
Time frame: 10 minutes
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
Time frame: 2 Days after conization
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
Time frame: 20 minutes
Operative complications
Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively
Time frame: 14 days
number of fragments of the surgical specimen
surgeons will count the number of the surgical specimen (1 vs. \>1)
Time frame: 10 minutes
The circumference of the surgical specimens
The circumference of the surgical specimens will be measured in cm
Time frame: 2 Days after conization
the length of the surgical specimens
The length of The surgical specimens will be measured in cm
Time frame: 2 Days after conization
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the thickness of the surgical specimens
The thickness of The surgical specimens will be measured in cm
Time frame: 2 Days after conization
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')
Time frame: 30 minutes
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 frame: 30 minutes
Time to complete intraoperative hemostasis
the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds
Time frame: 120 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
Time frame: 5 hours