Trial document





This trial has been registered retrospectively.
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  DRKS00016155

Trial Description

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Title

Evaluation of short- und long-term morbidity of bowel mobilisation in patients with epithelial ovarian cancer after primary undergoing debulking surgery with special interest on Low anterior resection syndrome (LARS) - a retrospective analysis.

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Trial Acronym

KEM-GO-2 (LARS)

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URL of the Trial

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Brief Summary in Lay Language

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Brief Summary in Scientific Language

The mainstay of advanced ovarian cancer therapy is debulking surgery and platinum-containing chemotherapy. Several studies demonstrated that primary cytoreductive surgery is an essential therapeutic step in the treatment of advanced ovarian cancer. In order to achieve no macroscopic residual disease, radical debulking surgery often comprises extensive upper abdominal and bowel operative procedures are performed. Anterior resection of the rectum, also known as low anterior resection, is frequently carried out in patients with advanced EOC
The aim of the present study is to describe the prevalence of the low anterior resection syndrome (LARS) in patients with advanced epithelial ovarian cancer after debulking surgery. LARS will be evaluated/assesed by predefined questionair.
As a control cohort patients undergoing surgery without anterior rectum resection and no abdominal surgery will also be part of the interview.

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Organizational Data

  •   DRKS00016155
  •   2019/07/29
  •   [---]*
  •   yes
  •   Approved
  •   2018179, Ethikkommission der Ärztekammer Nordrhein
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Secondary IDs

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Health Condition or Problem studied

  •   C56 -  Malignant neoplasm of ovary
  •   K59 -  Other functional intestinal disorders
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Interventions/Observational Groups

  •   Evaluation of the LARS score in patients undergoing debulking surgery for ovarian cancer who underwent sigma / rectosigmoid or deep anterior rectal resection.

    The "control cohort" will be:
    1) Ovarian cancer patients who underwent debulking surgery without sigma/rectum resection;
    2) breast cancer patients (matched-pair) who have neo / adjuvant chemotherapy based on their diagnosis but no history of abdominal/bowel surgery.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Other
  •   Open (masking not used)
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  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

The aim of the present study is to evaluate the prevalence of the low anterior resection syndrome (LARS) in patients with advanced epithelial ovarian cancer..

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Secondary Outcome

• Comparison of the prevalence of LARS in patients with ovarian cancer with and without sigma / rectosigmoid or deep anterior rectal resection and breast cancer patients who had no abdominal / intestinal surgery.
• Prevalence of minor LARS and major LARS in patients with ovarian cancer after sigma / rectosigmoid or deep anterior rectal resection.
* Evaluation of risk factors for LARS

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

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Recruitment

  •   Actual
  •   2019/01/21
  •   400
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

Ovarian cancer patients who underwent resection of sigma / rectosigmoid or deep anterior rectal resection during debulking surgery (period 2011-2018) will be recruited in this study. As a "control cohort" (this group will also be interviewed using the LARS questionnaire to record LARS score):
1) Patients who have also been treated for primary ovarian cancer but who did not receive bowel surgery as part of the debulking surgery; 2) breast cancer patients (matched-pair) who had neo / adjuvant chemotherapy based on breast cancer diagnosis, and no history of abdominal surgery .

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Exclusion Criteria

All patients with diverting ostomy, postoperative anastomotic leak, history of abdominal radiotherapy.

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Addresses

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    • Kliniken Essen-MitteAbteilung für Gynäkologie und Gyn. Onkologie
    • Henricistrasse 92
    • 45136  Essen
    • Germany
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    • Kliniken Essen-MitteAbteilung f. Gynäkologie und Gyn. Onkologie
    • Ms.  PD Dr. med.  Beyhan  Ataseven 
    • Henricistrasse 92
    • 45136  Essen
    • Germany
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    • Abteilung für Gynäkologie und Gynäkologische OnkologieKliniken Essen-Mitte
    • Ms.  PD Dr. med.  Beyhan  Ataseven 
    • Henricistrasse 92
    • 45136  Essen
    • Germany
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Sources of Monetary or Material Support

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    • Kliniken Essen-MitteAbteilung für Gynäkologie und Gyn. Onkologie
    • 45136  Essen
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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