Uterine Cervical Dysplasia
Conditions
Keywords
conization, LLETZ, cervical dysplasia, cervical intraepithelial neoplasia, Fischer cone biopsy excisor, loop electrosurgical excision procedure
Brief summary
In a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, two electrosurgical excision methods, Fischer Cone Biopsy Excison vs. Loop Excision Procedure, will be compared. The primary outcome of the study is dysplasia-free resection margin rate, secondary outcomes are intraoperative blood loss, time to complete hemostasis, intervention time, postoperative pain, intra- and postoperative complications, the resected cone volume and users satisfaction.
Detailed description
Conization is the method of choice in therapy for cervical dysplasia. Beside the risk of preterm delivery, the risk of a local relapse in patients with dysplasia-affected resection margin is high. The Goldstandard standard technique in conization for women with cervical dysplasia is the large loop excision of the transformation zone (LLETZ). Nevertheless other techniques such as the excision of the abnormal tissue with the so called Fischer Cone Biopsy Excisor could provide advantages and is yet not enough investigated. The loop excision technique uses a circular electrode, in contrast Fischer Cone Biopsy Excision is done by a triangular electrode. It is unknown, whether the use of the circular or the triangular electrode is superior regarding the dysplasia-free resection margin rate and other outcome parameters such as the resected cone volume, postoperative bleeding and postoperative pain. Therefore, the investigator designed a randomized clinical trial of 160 women undergoing conization for cervical dysplasia, comparing the two electrosurgical techniques, LLETZ-conization and Fischer Cone Biopsy Excision. The primary outcome of the study is the dysplasia-free resection margin rate independently proved by a pathologist, secondary outcomes are intraoperative blood loss measured as difference in serum hemoglobin pre- and postoperatively, postoperative pain according to a 11 step VAS scale, time to complete hemostasis measured in seconds, duration of the intervention measured in minutes, resected cone volume, users satisfaction according to a 11 step VAS scale and intra- and postoperative complications, defined as necessity to intervene surgically up to 14 days postoperatively. The study Population consists of women undergoing conization for histologically proven cervical dysplasia.
Interventions
PROCEDUREFischer Cone Biopsy Excisor
Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone
PROCEDURELoop Excision Procedure
Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone
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 * no known hematologic disorder
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 |
|---|---|---|
| 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain | 5 hours | patients will score their postoperative pain Level using a 11-step visual analogue scale (nVAS) and a 5-step graphical visual analogue scale (gVAS)within 5 hours after surgery |
| 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 |
| 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 |
| Resected cone volume | 10 minutes | The resected cone volume will be measured postoperative by using a scale |
| 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') |
| Operative complications | 14 days | Operative complications defined as necessity to intervene surgically up to 14 days postoperatively |
| number of fragments of the surgical specimen | 10 minutes | surgeons will count the number of the surgical specimen (1 vs. \>1) |
| 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') |
Countries
Germany
Outcome results
None listed