Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization

Study Overview
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Brief Summary
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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
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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.

Official Title
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Fischer Cone Biopsy Excisor Versus Loop Excision Procedure. A Randomized Trial of Two Operation Techniques in Women Undergoing Conization for Cervical Dysplasia

Conditions
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Uterine Cervical Dysplasia

Intervention / Treatment
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* Procedure: Fischer Cone Biopsy Excisor
* Procedure: Loop Excision Procedure


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fischer Cone Biopsy Excisor<br>Conization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor | Procedure: Fischer Cone Biopsy Excisor<br>* Electrosurgical excision method using a triangular electrode to remove the abnormal cervical Transformation zone<br>|
| Active Comparator: Loop Excision Procedure<br>Conization Methode using a circular electrode , i.e. Loop excision Procedure | Procedure: Loop Excision Procedure<br>* Electrosurgical excision method using a circular electrode to remove the abnormal cervical Transformation zone<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 2 Days after conization | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 5 hours | 
| Postoperative pain | 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 | 5 hours | 
| Time to complete intraoperative hemostasis | the time until complete hemostasis as judged by the surgeon has been achieved, will be measured in seconds | 120 seconds | 
| 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 | 20 minutes | 
| Resected cone volume | The resected cone volume will be measured postoperative by using a scale | 10 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') | 30 minutes | 
| 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') | 30 minutes | 
| Operative complications | Operative complications defined as necessity to intervene surgically up to 14 days postoperatively | 14 days | 
| number of fragments of the surgical specimen | surgeons will count the number of the surgical specimen (1 vs. >1) | 10 minutes | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conization, LLETZ, cervical dysplasia, cervical intraepithelial neoplasia, Fischer cone biopsy excisor, loop electrosurgical excision procedure