Fischer Cone Biopsy Excisor Versus Loop Excision Procedure for Conization
- Conditions
- Uterine Cervical Dysplasia
- Interventions
- Procedure: Loop Excision ProcedureProcedure: Fischer Cone Biopsy Excisor
- Registration Number
- NCT02515162
- Lead Sponsor
- Zydolab - Institute of Cytology and Immune Cytochemistry
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 178
- histologically proven cervical dysplasia
- colposcopy Prior to conization
- informed consent
- no known hematologic disorder
- significant language barrier
- a personal history of conization
- pregnancy
- the use of blood thinner
- unwillingness to participate
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Loop Excision Procedure Loop Excision Procedure Conization Methode using a circular electrode , i.e. Loop excision Procedure Fischer Cone Biopsy Excisor Fischer Cone Biopsy Excisor Conization Methode using a triangular electrode , i.e. Fischer Cone Biopsy Excisor
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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')
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)
Trial Locations
- Locations (1)
Department of Obstetrics and Gynecology of the Ruhr University Bochum
🇩🇪Herne, NRW, Germany