Uterine Cervical Dysplasia
Conditions
Keywords
conization, LLETZ, randomized controlled trial, loop excision, general anaesthesia, local anaesthesia
Brief summary
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.
Interventions
PROCEDURELLETZ under local anaesthesia
Conization will be performed under local anaesthesia
PROCEDURELLETZ under general anaesthesia
Conization will be performed under general anaesthesia
Sponsors
Zydolab - Institute of Cytology and Immune Cytochemistry
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Womens satisfaction | 2 hours | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| the resected cone mass | 10 minutes | the resected cone mass will be quantified by weighing the removed tissue with a precision scale located in the operating room |
| 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 |
| Operative complications | 14 days | Operative complications defined as necessity to intervene therapeutically up to 14 days postoperatively |
| 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 |
| Postoperative pain | 2 hours | 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 |
| Surgeons satisfaction | 20 minutes | Surgeons will score their satisfaction by using a 11-step visual analogue scale (VAS) 20 minutes after Treatment |
| number of fragments of the surgical specimen | 20 minutes | surgeons will count the number of the surgical specimen (1 vs. \>1) |
| 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 |
| the dimensions of the surgical specimens | 20 minutes | The circumference, length and thickness of The surgical specimens will be measured |
| 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 |
Countries
Germany
Outcome results
None listed