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Object of the study is the evaluation of the use of a rigid laparoscope for the diagnosis and therapy of lesions of the female genital tract as a substitution or a complementary method to colposcopy with the development of new standards for a tissue sparing therapy Use of existing laparoscopic instruments, which allow a better quality level in the diagnosis and therapy than the current routine.
Development of new optics and instruments, which allow a tissue sparing approach Pre and postoperative measurement of the cervical volume, to be sure that the tissue removal is kept to a minimum level Development of qualitaty parameters for the most tissue respecting operations of the uterine cervix Prospective evaluation of the influence of tissue sparing surgery on future pregnancies
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Colposcopy | Active Comparator | a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. |
|
| Vitom | Experimental | The VITOM system, consisting of the VITOM scope, xenon light source, HD camera system, AIDA HD documentation system, 1 monitor, and a mechanical support arm (all Karl Storz, Tuttlingen, Germany) is used for video exocolposcopy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitom | Device | Patients treated and diagnosed by vitom |
| |
| Colposcopy |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical volume removed | Cervical volume removed during the operation is recorded | İmmediately after surgery |
| İntraoperative Complications | Complications encountered during the prodecure | During the intraoperative |
| Short term complications | Complications within 48 hours after operation | Within 48 hours after operation |
| Late complications | Complications occuring after 48 hours | After 48 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Achim Schneider, MD, MPH | Charité University Hospital, Berlin, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Charité University Hospital | Berlin | State of Berlin | 12200 | Germany |
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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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| Device |
a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. Patients treated by colposcopy |
|
| 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 |