Trial document





This trial has been registered retrospectively.
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  DRKS00017030

Trial Description

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Title

Results of perioperative management and surgical treatment of primary colon carcinoma (KK) at a university surgical center over a 10-year period with a comparison of the multicentre observational study "Quality control colon carcinoma (primary tumor) - elective surgery" (AN Institute for Quality assurance in operative medicine GmbH at Otto von Guericke University Magdeburg)

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Trial Acronym

/

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URL of the Trial

http:///

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Brief Summary in Lay Language

It is a study of treatment data from the care of patients with a primary and fine tissue (histology) secured colon cancer at a clinic of the university medical care at (oncogenic) surgical early-post-operative and long-term aspects.
The data were obtained in routine care as part of a monocentric observational study at the time of treatment and partly retrospectively.
The aim of the work was to determine the surgical early-postoperative treatment outcome as well as the long-term cancer-surgical outcome and to investigate their influencing factors. Particular attention was paid to the occurrence of general (surgical-operative independent) and special (surgical-operative-dependent) complications to represent under different aspects.
Furthermore, the investigation and description of the essential survival parameters (cancer-long-term treatment outcome) in terms of overall survival, tumor-free survival and the local recurrence rate.

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Brief Summary in Scientific Language

Quality assurance studies make a valuable contribution to the optimization of the diagnostic and therapeutic procedure for the continuous improvement of the patient's outcomes in the oncologic treatment of colon carcinoma (CC).
The aim of the study was to evaluate the perioperative data of consecutive patients with histologically confirmed colon carcinoma (CC) over a defined period of time.
Over a period of 10 years, patients were prospectively recorded by means of a standardized registration form of the "AN-Institut für Qualitätssicherung (Otto-von-Guericke-University Magdeburg)" and retrospectively analyzed with regard to pre-, peri- and postoperative quality parameters in the early postoperative and postoperative period oncosurgical long-term outcome analyzes.
The KK-Outcome due to perioperative management and surgical procedure corresponds to the previously published data and represents a solid basis for the current quality of CC's operative care, especially for an identifiable internal quality assurance, not least also for clinic marketing and possible certification of a bowel center. The competent prospective continuation of the presented in-clinic quality assurance based on
i) the methodological know-how used,
ii) the representative primary data obtained (and)
iii) Statistical processing
appears.

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Organizational Data

  •   DRKS00017030
  •   2019/03/25
  •   [---]*
  •   yes
  •   No approval required according to EC
  •   R09-18, Ethikkommission der Medizinischen Fakultät der Otto-von-Guericke-Universität Magdeburg
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Secondary IDs

  •   U1111-1230-4751 
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Health Condition or Problem studied

  •   C18.9 -  Malignant neoplasm: Colon, unspecified
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Interventions/Observational Groups

  •   Over a period of 10 years, patients were prospectively recorded by means of a standardized registration form of the "AN-Institut für Qualitätssicherung (Otto-von-Guericke-University Magdeburg)" and retrospectively analyzed with regard to pre-, peri- and postoperative quality parameters in the early postoperative and postoperative period oncosurgical long-term outcome analyzes.
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Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Supportive care
  •   Single (group)
  •   N/A
  •   N/A
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Primary Outcome

The data collected cover patients who were in treatment from October 2002 to September 2012.

- Description of the treatment aspects (Among other things, determination of the surgical rate, resection rates, complication rates incl. Study period)
- Influence of:
* Patient (including age, gender, obesity, comorbidity profile [ASA score]),
* Tumor / findings (including tumor location, depth infiltration, UICC stage, histological detected nodal / lymph vessel / venous invasion, metastasis),
* Therapy-associated characteristics (urgency of operation (elective / emergency, surgical Indication (curative, palliative, antibiotics, surgical method)
and their influence on postoperative morbidity (general and special complications, especially anastomotic leakage, hospital allotment, spleen injury, wound healing disorders, peritonitis, hemorrhage).
- Influence of the described aspects on overall survival (OS), disease-free survival (DFS) and local recurrence rate (LRR).

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Secondary Outcome

Comparison of early postoperative outcome, OS and DFS and LRR - representative of the long-term oncosurgical outcome - in defined groups of the patient cohort to the multicentric study "Quality Assurance Colon Carcinoma (Primary Tumor) -Electual Surgery" (AN Institute for Quality Assurance in the operative Medizin GmbH at the Otto-von-Guericke University Magdeburg) as well as evaluation in the subdivided 10-year (investigation) period with regard to significant changes and trends.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2012/10/01
  •   614
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

Patients with care in the period from 01.10.2002 to 30.09.2012 under elective, urgent or emergency indication with pre-operative or postoperatively histologically confirmed primary colon carcinoma and primary surgical care. Tumor localization at the colon between the ileocecal (Bauhinian) flap to 16 cm orally of the anocutaneous line (measured with a rigid rectoscope).

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Exclusion Criteria

- Preoperative surgical care of primary colon carcinoma in an external care facility
- Surgical treatment of benign tumors and potential precancerous lesions that are not classified by histological classification as malignant colon tumors
- Single operative care of metastases or synchronous metastases and local recurrences of primary external patients
- Patients with a colon carcinoma primarily without definite preoperative height indication of the tumor localization in the rectosigmoid transition with intraoperatively proven rectal localization and resulting, more rectal carcinoma-specific surgical procedures
- Colon carcinoma patients who did not receive oncosurgical care

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Addresses

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    • Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Roland  Croner 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Frank  Meyer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Frank  Meyer 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinik für Allgemein-, Viszeral-, Gefäß- und Transplantationschirurgie
    • Mr.  Prof. Dr. med.  Roland  Croner 
    • Leipziger Str. 44
    • 39120  Magdeburg
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2017/02/28
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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.