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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLETZ under local anaesthesia | Experimental | The LLETZ procedure will be performed under local anaesthesia |
|
| LLETZ under general anaesthesia | Active Comparator | The LLETZ procedure will be performed under general anaesthesia |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLETZ under local anaesthesia | Procedure | Conization will be performed under local anaesthesia |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ziad Hilal, M.D. | Zydolab - Institute of Cytology and Immune Cytochemistry | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Obstetrics and Gynecology of the Ruhr University Bochum | Herne | North Rhine-Westphalia | 44625 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32585223 | Derived | Rezniczek GA, Hecken JM, Rehman S, Dogan A, Tempfer CB, Hilal Z. Syringe or mask? Loop electrosurgical excision procedure under local or general anesthesia: a randomized trial. Am J Obstet Gynecol. 2020 Dec;223(6):888.e1-888.e9. doi: 10.1016/j.ajog.2020.06.041. Epub 2020 Jul 24. |
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| ID | Term |
|---|---|
| D002578 | Uterine Cervical Dysplasia |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D002577 | Uterine Cervical Diseases |
| D014591 | Uterine Diseases |
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| LLETZ under general anaesthesia | Procedure | Conization will be performed under general anaesthesia |
|
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 |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |