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| Name | Class |
|---|---|
| Ruhr University of Bochum | OTHER |
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To assess the benefits of large Loop excision of the transformation Zone (LLETZ) under direct colposcopic Vision.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLETZ with colposcopy | Experimental | The LLETZ procedure will be performed under direct colposcopic vision |
|
| LLETZ without colposcopy | Active Comparator | The LLETZ procedure will be performed without colposcopy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLETZ with colposcopy | Device | Loop procedure using a colposcope in order to see and remove the abnormal cervical tissue |
|
| 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 |
| 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 |
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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 |
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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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| ID | Term |
|---|---|
| D003127 | Colposcopy |
| ID | Term |
|---|---|
| D003944 | Diagnostic Techniques, Obstetrical and Gynecological |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D004724 | Endoscopy |
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| LLETZ without colposcopy | Other | Loop procedure without using a colposcope |
|
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 |
| D005831 |
| Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D003949 | Diagnostic Techniques, Surgical |
| D019060 | Minimally Invasive Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D013513 | Obstetric Surgical Procedures |
| D013509 | Gynecologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |