Trial document





This trial has been registered retrospectively.
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  DRKS00015052

Trial Description

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Title

DO CARCINOMAS OF THE RECTOSIGMOID JUNCTION BELONG TO THE UPPER RECTUM OR SIGMOID COLON?

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Therapy of cancer in the colon and rectum evolves continuously and is becoming more and more diversified and individualized. There is little information on tumors in the segment in between, the rectosigmoid junction. A retrospective analysis of all patients operated on for a carcinoma in the sigmoid colon, the rectosigmoid junction and the upper rectum between the years 2004 and 2014 will be performed.
The objective of this study is to determine whether carcinomas of the rectosigmoid junction have to be considered independently or can be assigned to the upper rectum or to the sigmoid colon taking into account tumor characteristics and the oncological outcome.

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Brief Summary in Scientific Language

Therapy of cancer in the colon and rectum evolves continuously and is becoming more and more diversified and individualized. There is little information on tumors in the segment in between, the rectosigmoid junction. A retrospective analysis of all patients operated on for a carcinoma in the sigmoid colon, the rectosigmoid junction and the upper rectum between the years 2004 and 2014 will be performed.
The objective of this study is to determine whether carcinomas of the rectosigmoid junction have to be considered independently or can be assigned to the upper rectum or to the sigmoid colon taking into account tumor characteristics and the oncological outcome.

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Organizational Data

  •   DRKS00015052
  •   2018/07/09
  •   [---]*
  •   yes
  •   Approved
  •   273/2010BO2, Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum Tübingen
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Secondary IDs

  •   U1111-1216-7448 
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Health Condition or Problem studied

  •   Primary colorectal carcinomas
  •   C19 -  Malignant neoplasm of rectosigmoid junction
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Interventions/Observational Groups

  •   A retrospective analysis of all patients operated on for a carcinoma in the sigmoid colon, the rectosigmoid junction and the upper rectum between the years 2004 and 2014 will be performed.
    The objective of this study is to determine whether carcinomas of the rectosigmoid junction have to be considered independently or can be assigned to the upper rectum or to the sigmoid colon taking into account tumor characteristics and the oncological outcome.
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Characteristics

  •   Non-interventional
  •   Other
  •   Other
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Other
  •   Other
  •   N/A
  •   N/A
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Primary Outcome

Patient and tumor characteristics: evaluation of perioperative findings; oncological outcome (tumor recurrence and death); Query by a standardized questionnaire (via mail or telephone interview) or by a query from the local cancer registry (follow-up in the median: 44 months)

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Secondary Outcome

/

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2013/01/01
  •   337
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   99   Years
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Additional Inclusion Criteria

resection of a primary carcinoma of the sigmoid colon, the rectosigmoid junction or the upper rectum; clear assignment to one of the three segments (endoscopy); resection with anastomosis

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Exclusion Criteria

carcinoma in situ, tumors, which could not be clearly assigned to one of the three segments, resection without anastomosis (e.g. Hartmann’s procedure, transanal minimally invasive surgery, exstirpation), emergency resections

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Addresses

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    • Universitätsklinikum Tübingen
    • Geissweg 3
    • 72076  Tübingen
    • Germany
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    • Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
    • Mr.  Dr. med.  Claudius  Falch 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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    • Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
    • Mr.  Dr. med.  Claudius  Falch 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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Sources of Monetary or Material Support

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    • Klinik für Allgemeine, Viszeral- und Transplantationschirurgie, Universitätsklinikum Tübingen
    • Mr.  Dr. med.  Claudius  Falch 
    • Hoppe-Seyler-Str. 3
    • 72076  Tübingen
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2015/12/31
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Trial Publications, Results and other Documents

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