LLETZ Under General Versus Local Anesthesia

Study Overview
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Brief Summary
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The investigators conduct a prospective, randomized trial to assess the benefits of performing large loop excision of the transformatione zone (LLETZ) under local anesthesia and compare it to LLETZ under general anesthesia. The primary endpoint of this study is women´s satisfaction.

Official Title
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Large Loop Excision of the Transformatione Zone Under General Versus Local Anesthesia: a Randomized Trial.

Conditions
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Uterine Cervical Dysplasia

Intervention / Treatment
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* Procedure: LLETZ under local anaesthesia
* Procedure: LLETZ under general anaesthesia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: colposcopy Prior to conization informed consent histologically proven high grade cervical dysplasia Transformation zone typ 1 or 2 Exclusion Criteria: significant language barrier a personal history of conization pregnancy the use of blood thinner unwillingness to participate oncological disease inpatient treatment women who are not fasting risk of aspiration columnar-squamous epithelium border not fully visible

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: LLETZ under local anaesthesia<br>The LLETZ procedure will be performed under local anaesthesia | Procedure: LLETZ under local anaesthesia<br>* Conization will be performed under local anaesthesia<br>|
| Active Comparator: LLETZ under general anaesthesia<br>The LLETZ procedure will be performed under general anaesthesia | Procedure: LLETZ under general anaesthesia<br>* Conization will be performed under general anaesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Womens satisfaction | Patients will score their satisfaction by using a 11-step visual analogue scale (VAS) ranging from '0' (not satisfied at all) to '10' (very satisfied) 2 hours after Treatment | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain | patients will score their postoperative pain Level using a 11-step visual analogue scale (VAS) ranging from '0' (no pain ) to '10' (maximum pain) within 2 hours after surgery | 2 hours | 
| 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 | 
| 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 | 
| 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 | 
| Surgeons satisfaction | Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment | 20 minutes | 
| number of fragments of the surgical specimen | surgeons will count the number of the surgical specimen (1 vs. >1) | 20 minutes | 
| the dimensions of the surgical specimens | The circumference, length and thickness of The surgical specimens will be measured | 20 minutes | 
| 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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conization, LLETZ, randomized controlled trial, loop excision, general anaesthesia, local anaesthesia