LLETZ Under Direct Colposcopic Vision

Study Overview
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Brief Summary
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To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.

Official Title
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Direct Colposcopic Vision and Large Loop Excision of the Transformation Zone in Women With Cervical Dysplasia: a Randomized Controlled Trial.

Conditions
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Uterine Cervical Dysplasia

Intervention / Treatment
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* Device: LLETZ with colposcopy
* Other: LLETZ without colposcopy


Participation Criteria
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Eligibility Criteria
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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

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: LLETZ with colposcopy<br>The LLETZ procedure will be performed under direct colposcopic vision | Device: LLETZ with colposcopy<br>* Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue<br>|
| Active Comparator: LLETZ without colposcopy<br>The LLETZ procedure will be performed without colposcopy | Other: LLETZ without colposcopy<br>* Loop procedure without using a colposcope<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 10 minutes | 

Secondary 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 | 
| 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 | 
| Operative complications | Operative complications defined as necessity to intervene therapeutically 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 | 
| the dimensions of the surgical specimens | The circumference, length and thickness of The surgical specimens will be measured | 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') | 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') | 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 | 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 | 5 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conization, LLETZ, loop excision, randomized controlled trial, colposcopy, direct colposcopic vision, intraoperative colposcopy