Uterine Cervical Dysplasia
Conditions
Keywords
conization, LLETZ, loop excision, randomized controlled trial, colposcopy, direct colposcopic vision, intraoperative colposcopy
Brief summary
To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
Interventions
DEVICELLETZ with colposcopy
Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue
OTHERLLETZ without colposcopy
Loop procedure without using a colposcope
Sponsors
Ruhr University of Bochum
Zydolab - Institute of Cytology and Immune Cytochemistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the resected cone mass | 10 minutes | the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| number of fragments of the surgical specimen | 10 minutes | surgeons will count the number of the surgical specimen (1 vs. \>1) |
| the dimensions of the surgical specimens | 2 Days after conization | The circumference, length and thickness of The surgical specimens will be measured |
| Margin status | 2 Days after conization | 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 | 20 minutes | 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 | 14 days | Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively |
| satisfaction with the device | 30 minutes | 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 | 120 seconds | the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds |
| Intraoperative blood loss | 5 hours | intraoperative blood loss will be measured using the difference in serum hemoglobin one day prior to surgery and within 5 hours postoperatively |
| handling of the device | 30 minutes | 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') |
Countries
Germany
Outcome results
None listed