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| Name | Class |
|---|---|
| Ruhr University of Bochum | OTHER |
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To assess the benefits of performing large Loop excision of the transformation Zone (LLETZ) using videocolposcopy compared to binocular colposcopy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LLETZ with videocolposcopy | Experimental | The LLETZ procedure will be performed using a videocolposcopy |
|
| LLETZ with binocular colposcopy | Active Comparator | The LLETZ procedure will be performed using a binocular colposcope |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LLETZ with videocolposcope | Device | Loop procedure using a videocolposcope 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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34802113 | Derived | Rezniczek GA, Neghabian N, Rehman S, Tempfer CB. Video colposcopy versus headlight for large loop excision of the transformation zone (LLETZ): a randomised trial. Arch Gynecol Obstet. 2022 Feb;305(2):415-423. doi: 10.1007/s00404-021-06331-0. Epub 2021 Nov 21. |
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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 with binocular colposcope | Device | Loop procedure using a binocular colposcope in order to see and remove the abnormal cervical tissue |
|
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 circumference of the surgical specimens | The circumference of the surgical specimens will be measured in cm | 2 Days after conization |
| the length of the surgical specimens | The length of The surgical specimens will be measured in cm | 2 Days after conization |
| the thickness of the surgical specimens | The thickness of The surgical specimens will be measured in cm | 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 |