Trial document





This trial has been registered retrospectively.
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  DRKS00013084

Trial Description

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Title

Retrospective multicenter study for comparison of two surgical techniques (LAP vs. LSK) as therapy of early-staged ovarian cancer and borderline-tumor of the ovaries in regards to intra- and postoperative complications, oncological outcome and fertility preservation.

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

The study's aim is to consider the safety of minimally-invasive surgery as surgical technique for therapy of ovarian cancer and borderline-tumor of the ovaries. Patients treated with this option shall be compared to patients who underwent an open surgery.
To analyze are surgical parameters like blood loss, complications or postoperative hospital stay.
Furthermore the follow-up after surgery is an important point to be evaluated.
Special attention shall be payed for women with childbearing preferences.

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Brief Summary in Scientific Language

This project is a retrospective multi center study to evaluate the safety of minimally-invasive surgery of malignant and semi-malignant tumors of the ovaries. If laparoscopy can be an alternative option in some special cases is one of the central issues.
Especially women with the admire to have children after surgery shall be examined.
This group will be compared to a reference group of women, who were treated by laparotomy. To examine are on the one hand surgical parameters like blood-loss, surgery duration, complications and postoperative hospital stay and on the other hand the postoperative follow-up.
For scientific research the data of all patients who underwent laparoscopic surgery due to early-staged malignant/semi-malignant ovarian cancer at one of the included hospitals from 1998 - 2017 will be acquired and analyzed.
Included hospitals are first of all the Saarland University hospital. In the course of time other medical centers shall be included.

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Organizational Data

  •   DRKS00013084
  •   2018/04/26
  •   [---]*
  •   yes
  •   Approved
  •   155/17, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   C56 -  Malignant neoplasm of ovary
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Interventions/Observational Groups

  •   Minimally-invasive surgery at malignant neoplasms of the ovaries.
    Retrospective data assesment and analysation of surgical parameters and follow-up Data out of digitalized and archived patient files. Patients, who recently (2017) underwent surgical treatment will be followed-up prospectively.
  •   Open surgery at malignant neoplasms of the ovaries.
    Retrospective data assesment and analysation of surgical parameters and follow-up Data out of digitalized and archived patient files. Patients, who recently (2017) underwent surgical treatment will be followed-up prospectively.
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Characteristics

  •   Non-interventional
  •   Epidemiological study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

The primary endpoints are the relapse-free survival and the overall survival of the patients.
Therefore a Follow-Up off all included patients will be made. On the one hand this will be achived through retrospective data research and on the other hand through communication with the patients. Women who underwent surgical treatment recently (2017) will be followed-up prospectively over a period of approximately 10 years in addition.

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Secondary Outcome

Secondary endpoints are the surgical outcome like surgery time, blood loss, intra- and postoperative complications and postoperative hospital stay. In women who got fertility-conserving surgery the fertility will also be a secondary endpoint.
These parameters will be collected via data research out of digitized and archived medical records.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2017/10/01
  •   120
  •   Multicenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

Included are all patients who got surgical treatment for early-staged malignant neoplasms of the ovaries and borderline-tumors of the ovaries at University Medical Center Homburg/Saar from 01/1998 to 07/2017.
Furthermore, in a second step, all patients with similar criteria, who got surgical treatment in one of our cooperating medical centers are included.
Early-staged tumors are T1 and T2 stage tumors.
Subsequently the patients will be separated in two groups: laparoscopic treatments versus open surgical treatment via abdominal incision.

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Exclusion Criteria

1. Laparoscopy because of benign neoplasms of the ovaries.
2. Minimally-invasiv surgery at advanced ovarial carcinoma.
3. Incomplete data.

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Addresses

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    • Universitätsklinikum des Saarlandes
    • 66421  Homburg/Saar
    • Germany
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    • Universitätsfrauenklinik Homburg
    • Ms.  Dr.  Julia  Radosa 
    • Kirrberger Straße, Gebäude 9
    • 66421  Homburg
    • Germany
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    • Universitätsfrauenklinik Homburg
    • Ms.  Dr.  Julia  Radosa 
    • Kirrberger Straße, Gebäude 9
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsfrauenklinik Homburg
    • Mr.  Prof. Dr. med.  Erich-Franz  Solomayer 
    • Kirrberger Straße, Gebäude 9
    • 66421  Homburg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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* This entry means the parameter is not applicable or has not been set.