Tissue Sparing Therapy of Female Precancerous Genital Lesions With VITOM

Not Applicable

• Conditions: Cervical Preinvasive Disease
• Interventions: Device: Colposcopy; Device: Vitom

• Registration Number: NCT01601769
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2011-04
• Status Verified: 2012-05
• Study First Submitted: 2012-05-14
• Study First Submitted QC: 2012-05-16
• Last Update Submitted: 2012-05-16
• Study First Posted: 2012-05-18
• Last Update Posted: 2012-05-18
• Primary Completion: 2012-07
• Study Completion: 2012-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Colposcopy	Colposcopy	a Carl Zeiss colposcope with a magnification power from 4x to 20x, with green filter.
Vitom	Vitom	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.

Primary Outcome Measures

Name	Time	Method
Cervical volume removed	İmmediately after surgery	Cervical volume removed during the operation is recorded
İntraoperative Complications	During the intraoperative	Complications encountered during the prodecure
Short term complications	Within 48 hours after operation	Complications within 48 hours after operation
Late complications	After 48 hours	Complications occuring after 48 hours

Trial Locations

Locations (1)

Charité University Hospital; 🇩🇪 Berlin, Germany