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
Organizational Data
- DRKS-ID:
- DRKS00006169
- Recruitment Status:
- Recruiting complete, study continuing
- Date of registration in DRKS:
- 2014-07-30
- Last update in DRKS:
- 2017-01-30
- Registration type:
- Prospective
Acronym/abbreviation of the study
ECO-ROCS trial (Evaluation of Clinical Outcome after Reduction of Conization Size)
URL of the study
No Entry
Brief summary in lay language
No Entry
Brief summary in scientific language
According to national and international guidelines, non-pregnant patients with cervical intraepithelial neoplasia grade 3 (CIN III) should be treated by cervical conization. In accordance with the definition of LLETZ (large loop excision of the transformation zone) the lesion including the transformation zone needs to be resected. It is well known from the literature, that the cone size directly correlates with the risk of preterm delivery in the course of a future pregnancy. The aim of this study is therefore, to analyse if the resection of the lesion only (without additional excision of the transformation zone) is equally effective regarding oncological outcome. Primary endpoint is a negative HPV test 6 and 12 months after the operation.
Health condition or problem studied
- Free text:
- CIN III
- ICD10:
- N87.2 - Severe cervical dysplasia, not elsewhere classified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- LLETZ (Large Loop Excision of the Transformation Zone)
- Arm 2:
- Resection of the dysplastic lesion with no additional resection of the transformation zone
Endpoints
- Primary outcome:
- Negative HPV test 6 and 12 months after the operation
- Secondary outcome:
- resection margin of the cone specimen, pap smear 6 and 12 months postop
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Active control (effective treatment of control group)
- Phase:
- N/A
- Study type:
- Interventional
- Mechanism of allocation concealment:
- No Entry
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting complete, study continuing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Gynäkologie Hannover
- Doctor's practice Stralsund
- Medical center Gynäkologie Kiel
- University medical center Gynäkologie Berlin
- Medical center Gynäkologie Bad Saarow
- University medical center Gynäkologie Düsseldorf
- University medical center Gynäkologie Regensburg
- University medical center Gynäkologie Aachen
- University medical center Klinikum Großhadern - Gynäkologie München
- University medical center Gynäkologie Hamburg
- Medical center Gynäkologie Wolfsburg
- Other Zentrale Dysplasiesprechstunde Münster Münster
- University medical center Universitätsfrauenklinik Ulm Ulm
- Doctor's practice München
Recruitment period and number of participants
- Planned study start date:
- 2014-08-01
- Actual study start date:
- 2014-09-04
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 1000
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- Female
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- CIN III, positive HPV test
Exclusion Criteria
-pregnancy until 6 months postop -malignant diseases requiring treatment -intake of immunosuppressants -HIV
Addresses
Primary Sponsor
- Address:
- Klinik für Frauenheilkunde und Geburtshilfe GroßhadernProf. Dr. med. Christian DanneckerMarchioninistraße 1581377 MünchenGermany
- Telephone:
- 089-4400-0
- Fax:
- 089-4400-76840
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - GroßhadernDr. Theresa KolbenMarchioninistr. 1581377 MünchenGermany
- Telephone:
- 089-4400-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Contact for Public Queries
- Address:
- Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - GroßhadernDr. Theresa KolbenMarchioninistr. 1581377 MünchenGermany
- Telephone:
- 089-4400-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Principal Investigator
- Address:
- Klinik und Poliklinik für Frauenheilkunde und Geburtshilfe - GroßhadernDr. Theresa KolbenMarchioninistr. 1581377 MünchenGermany
- Telephone:
- 089-4400-0
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Klinik für Frauenheilkunde und Geburtshilfe GroßhadernMarchioninistraße 1581377 MünchenGermany
- Telephone:
- 089-4400-0
- Fax:
- 089-4400-76840
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission der Med. Fakultät der LMUPettenkoferstraße 880336 MünchenGermany
- Telephone:
- +49-89-440055191
- Fax:
- +49-89-440055192
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2014-06-07
- Ethics committee number:
- 275-14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-07-10
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry