Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

Study Overview
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Brief Summary
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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

Official Title
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Development of a Tissue Sparing Procedure for the Diagnosis and Therapy of Female Precancerous Genital Lesions Combining Endoscopic and Ultrasound Technics.

Conditions
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Cervical Preinvasive Disease

Intervention / Treatment
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* Device: Vitom
* Device: Colposcopy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Karnowsky-Index > 80, 18-80 years, CIN. Exclusion Criteria: Pregnancy, Previous or current cancer, Radio therapy of the pelvis, Serious internistic accompanying diseases, Psychiatric diseases, HIV infection, Drug addiction.
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Colposcopy<br>a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. | Device: Colposcopy<br>* a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter. Patients treated by colposcopy<br>|
| Experimental: Vitom<br>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. | Device: Vitom<br>* Patients treated and diagnosed by vitom<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cervical preinvasive disease, Colposcopy, Exocolposcopy, Leep