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Register:	German Clinical Trials Register
Last refreshed on:	8 April 2024
Main ID:	DRKS00006169
Date of registration:	30/07/2014
Prospective Registration:	Yes
Primary sponsor:	Klinik für Frauenheilkunde und Geburtshilfe Großhadern
Public title:	Comparison of two surgical methods for the treatment of CIN: Classical LLETZ (Large Loop Excision of the Transformation Zone) versus isolated resection of the colposcopic apparent lesion
Scientific title:	Comparison of two surgical methods for the treatment of CIN: Classical LLETZ (Large Loop Excision of the Transformation Zone) versus isolated resection of the colposcopic apparent lesion - ECO-ROCS trial (Evaluation of Clinical Outcome after Reduction of Conization Size)
Date of first enrolment:	04/09/2014
Target sample size:	1000
Recruitment status:	Complete
URL:	http://drks.de/search/en/trial/DRKS00006169
Study type:	interventional
Study design:	Allocation: Randomized controlled study; Masking: Blinded (masking used); Control: active; Assignment: parallel; Study design purpose: treatment
Phase:	N/A

Countries of recruitment
Germany

Contacts

Name:	Theresa Kolben
Address:	Marchioninistr. 15 81377 München Germany
Telephone:	089-4400-0
Email:	theresa.kolben@med.uni-muenchen.de
Affiliation:	Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Großhadern

Name:	Theresa Kolben
Address:	Marchioninistr. 15 81377 München Germany
Telephone:	089-4400-0
Email:	theresa.kolben@med.uni-muenchen.de
Affiliation:	Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - Großhadern

Key inclusion & exclusion criteria

Inclusion criteria: CIN III, positive HPV test
Exclusion criteria: -pregnancy until 6 months postop
-malignant diseases requiring treatment
-intake of immunosuppressants
-HIV

Age minimum: 18 Years
Age maximum: None
Gender: Female

Health Condition(s) or Problem(s) studied

CIN III
N87.2

N87.2

Severe cervical dysplasia, not elsewhere classified

Intervention(s)

Group 1: LLETZ (Large Loop Excision of the Transformation Zone)
Group 2: Resection of the dysplastic lesion with no additional resection of the transformation zone

Primary Outcome(s)

Negative HPV test 6 and 12 months after the operation

Secondary Outcome(s)

resection margin of the cone specimen, pap smear 6 and 12 months postop

Secondary ID(s)

Source(s) of Monetary Support

Klinik für Frauenheilkunde und Geburtshilfe Großhadern

Secondary Sponsor(s)

Ethics review

Status: Approved
Approval date: 10/07/2014
Contact:

ethikkommission@med.uni-muenchen.de

Ethikkommission der Med. Fakultät der LMU

+49-89-440055191

ethikkommission@med.uni-muenchen.de

Results

Results available:
Date Posted:
Date Completed:
URL:	http://drks.de/search/en/trial/DRKS00006169#studyResults

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