Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00012400

Trial Description

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Title

Prospektive Evaluation of specimen quality for right sided colon cancer surgery

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Trial Acronym

RESECTAT

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URL of the Trial

http://www.resektatstudie.de

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Brief Summary in Lay Language

This study evaluates the concept of complete mesocolic excision in right sided large bowel cancer. This concept is an operation method in which the entire blood supply and the lymphatic drainage area of a large bowel segment that carries a tumour is removed in one package.

In this study it is evaluated if survival is better if all criteria of the complete mesocolic excison are fulfilled. The survial of those with complete fullfilled criteria is compared with those in whom the criteria are not fulfilled. In order to do so both groups are are followed for five years.

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Brief Summary in Scientific Language

One of the big controversies in colorectal cancer research is whether complete mesocolic excision (CME) offers a benefit for patients with carcinoma of the right colon or whether it might even harm these patients. A randomized trial to clarify this question has often been advocated. However, setting up such a trial is hampered by a major problem, which is mainly related to the difficulty of defining a standardized control group. First, there is no consensus of a standard non-CME hemicolectomy. Second, a surgeon who has been trained for CME will performa “standard” right hemicolectomy differently than before. It won’t be the traditional hemicolectomy but a 5/6 CME-hemicolectomy, thus making it very difficult to detect a difference. Our
approach to answering the question was a multicenter, non-randomized, registrybased trial with centralized assessment of the entire specimen.

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Organizational Data

  •   DRKS00012400
  •   2017/09/29
  •   [---]*
  •   yes
  •   Approved
  •   2009-118-f, Ethik-Kommission bei der Landesärztekammer Baden-Württemberg
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Secondary IDs

  •   U1111-1200-6710 
  •   607  (DKSR Deutsches Krebsstudienregister)
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Health Condition or Problem studied

  •   C18 -  Malignant neoplasm of colon
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Interventions/Observational Groups

  •   Patients with right sided colon carcinoma are operated according to the hospitals standard. The degree of radicality ist noted and a photograph of the specimen is made. Thereafter, the specimen is sent for central pathological evaluation. Using the documentation, the photographs and the pathological evaluation the specimens are classified as CME or non-CME.
    Criteria for CME are as follows: Intact mesocolon with identifiable Ileocolic and middle Colic artery (right branch) connected by the surgical trunk. In addition, for CME the dissection of the sup. mesenteric vein has to be documented. All specimens in which at least one criterion is not fulfilled are classified as non-CME. These two groups are then followed for five years and the rates of survival are compared
  •   Controls are those patients with speciems that do not fulfill the CME criteria
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Characteristics

  •   Non-interventional
  •   Other
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Other
  •   Treatment
  •   Other
  •   N/A
  •   No
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Primary Outcome

5 year disease free surviva. Assessment by contacting the General practitioner of the patients (yearly).

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Secondary Outcome

5 Year Overall-survival
postoperative morbidity and mortality

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2012/02/24
  •   668
  •   Multicenter trial
  •   National
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Inclusion Criteria

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

- Histologically proven adenocarcinoma of the colon - preoperative UICC stage I-III for scheduled surgery in curative intention
- Localisation coecum, ascending colon and hepatic flexure
- Pathologic stages UICC I-III
- Age >18 years
- Complete informed consent

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Exclusion Criteria

- Colon Carcinomas distal to the hepatic flexure
- Multiple carcinomas
- Polyposis syndromes (FAP, Peutz-Jeghers S., Cronkhite-Canada S, Gardner S)
- other maligne conditions excluding basaliomas
- infammatory bowel disease (ulcerative colitis, Crohns disease, indeterminate colitis)
- emergency operations
- previous colon surgery
- impossible informed consent
- UICC stage IV
- previous Chemo- or Radiotherapy
- severes resepiratory or cardial insuffuciency, (NYHA IV), O2-Therapy
- terminal renal failure
- Liver failure (Bilirubin 1,5 mg %)
- Severe neurologic disorders
- Gravidity
- Contraindication against adjuvant Chemotherapy according to S3-guidelines
- HIV
- Hepatitis B/C
- persiting bacterial infection
- Rejection of data aquisition as required by the protocol

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinikverbund-suedwest
    • Mr.  Prof.  Stefan  Benz 
    • Bunsenstr. 120
    • 71032  Böblingen
    • Germany
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    • Bonfatius Hospital Lingen gGmbHKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr. med.  Christoph  Sedelmayer 
    • Wilhelmstraße 13
    • 49808  Lingen/Ems
    • Germany
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    • Klinikum BambergDarmkrebszentrum
    • Mr.  Georg  Pistorius 
    • Buger Straße 80
    • 96049  Bamberg
    • Germany
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    • Vinzenzkrankenhaus HannoverDarmzentrum
    • Mr.  prof.  Armein  Meister 
    • Lange-Feld-Straße 31
    • 30559  Hannover
    • Germany
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    • Evangelisches Krankenhaus DinslakenKlinik für Chirurgie
    • Mr.  Prof.  Jochen  Erhard 
    • Kreuzstraße 28
    • 46535  Dinslaken
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    • Fürst-Stirum-Klinik BruchsalKlinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Mr.  Prof.  Sven  Richter 
    • Gutleutstraße 1-14
    • 746646  Bruchsal
    • Germany
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    • GRP Klinikum RüsselsheimDarmkrebszentrum
    • Mr.  Dr.  Michael  Habekost 
    • August-Bebel-Straße 59
    • 65428  Rüsselsheim
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    • HELIOS Klinikum SiegburgDarmkrebszentrum
    • Mr.  PD Dr.  Joachim  Seifert 
    • Ringstraße 49
    • 53721  Siegburg
    • Germany
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    • Klinikum AnsbachKlinik für Allgemein- und Viszeralchirurgie, Chirurgische Onkologie
    • Mr.  Prof.  Thomas  Meyer 
    • Escherichstraße 1
    • 91522  Ansbach
    • Germany
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    • Main-Kinzig-Kliniken Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Mr.  Dr.  Thomas  Zoedler 
    • Herzbachweg 14
    • 63571  Gelnhausen
    • Germany
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    • Kliniken des Landkreises Neumarkt i.d.OPf.Chirurgische Klinik
    • Ms.  Prof.  bettina  Rau 
    • Nürnberger Straße 12
    • 92318  Neumarkt i.d. OPf.
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    • Klinikum Barnim GmbHWerner Forßmann KrankenhausKlinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurigie
    • Mr.  Dr.  Stefan  Reumuth 
    • Rudolf-Breitscheid-Straße 100
    • 16225  Eberswalde
    • Germany
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    • Klinikum Hanau GmbH
    • Mr.  Prof. 
    • Leimenstraße 20
    • 63450  Hanau
    • Germany
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    • KRH Klinikum Hannover SiloahKlinik für Allgemein-, Viszeral- und minimalinvasive Chirurgie
    • Mr.  Prof.  Thomas  Moesta 
    • Stadionbrücke 4
    • 30459  Hannover
    • Germany
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    • Klinikum HeidenheimKlinik für Viszeral-, Thorax- und Gefäßchirurgie
    • Mr.  Prof.  Andreas  Imdahl 
    • Schloßhaustraße 100
    • 89522  Heidenheim an der Brenz
    • Germany
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    • Klinikum Kreis HerfordUniversitätsklinik für Allgemein- und Viszerachirurgie, Thoraxchirurgie und Proktologie
    • Mr.  Prof.  Günther  Winde 
    • Schwarzenmoorstraße 70
    • 32049  Herford
    • Germany
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    • Regio Klinikum PinnebergKlinik für Allgemein-, Viszeral-, Thorax- und Gefäßchirurgie
    • Mr.  PD Dr.  Hamid  Mofid 
    • Fahltskamp 74
    • 25421  Pinneberg
    • Germany
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    • KRH Klinikum Robert Koch GehrdenKlinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Mr.  Dr.  martin  Memming 
    • Von-Reden-Straße 1
    • 30989  Gerden
    • Germany
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    • AMEOS Klinikum SchönebeckKlinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Mr.  Dr  Jens Peter  May 
    • Köthener Straße 13
    • 39218  Schönebeck
    • Germany
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    • Klinikum St. Marien AmbergKlinik für Allgemein-, Viszeral- und Thoraxchirurgie
    • Mr.  Dr.  Wolfram  Schief 
    • Mariahilfbergweg 7
    • 92224  Amberg
    • Germany
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    • HELIOS Klinikum UelzenKlinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Mr.  Dr.  Ralph  Kather 
    • Hagenskamp 34
    • 29525  Uelzen
    • Germany
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    • Krankenhaus Bethanien MörsKlinik für Allgemein- und Viszeralchirurgie
    • Dr.  Hans-Reiner  Zachert 
    • Bethanienstraße 21
    • 47441  Mörs
    • Germany
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    • Krankenhaus BuchholzKlinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Mr.  Dr.  Michael  Scheruhn 
    • Steinbecker Straße 44
    • 21244  Buchholz
    • Germany
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    • Kliniken an der PaarKrankenhaus FriedbergKlinik für Allgemein- und Viszralchirurgie
    • Mr.  Dr.  Fritz  Lindemann 
    • Herrgottsruhstraße 3
    • 86316  Friedberg
    • Germany
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    • Klinikverbund SüdwestKrankenhaus LeonbergKlinik für Allgemein- und Viszeralchirurgie mit Proktologie
    • Mr.  Dr.  Karl-Joseph  Paul 
    • Rutesheimer Straße 50
    • 71229  Leonberg
    • Germany
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    • Klinikverbund SüdwestKreisklinikum Calw-Nagold
    • Mr.  Dr.  Ralf  Wilke 
    • Röntgenstr. 20
    • 72202  Nagold
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    • SRH Kliniken Landkreis Sigmaringen GmbHKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr.  Hubert  Hug 
    • Hohenzollernstraße 40
    • 72488  Sigmaringen
    • Germany
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    • Krankenhaus St. Joseph-Stift DresdenKlinik für Chirurgie
    • Mr.  Dr.  Martin  Freitag 
    • Wintergartenstraße 15/17
    • 01307  Dresden
    • Germany
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    • Krankenhaus WinsenKlinik für Allgemein-, Viszeral und Thoraxchirurgie
    • Mr.  Dr.  Holger  Meisel 
    • Friedrich-Lichtenauer-Allee 1
    • 21423  Winsen
    • Germany
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    • HELIOS Klinikum GifhornKlinikum für Allgemein-, Viszeral- und minimalinvasive Chirurgie
    • Mr.  Dr.  Roger  Kuhn 
    • Campus 6
    • 38518  Gifhorn
    • Germany
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    • REGIOMED KlinikenKrankenhaus LichtenfelsAllgemein- und Viszeralchirurgie
    • Mr.  Dr.  Emilio  Dominguez 
    • Prof.-Arneth-Straße 2
    • 96215  Lichtenfels
    • Germany
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    • Lukas-Krankenhaus BündeKlinik für Allgemein-, Visceal- und Minimal-Invasive Chirurgie
    • Mr.  Dr.  Stefan  Krummbein 
    • Hindenburgstraße 56
    • 32257  Bünde
    • Germany
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    • Malteser Krankenhaus Seliger GerhardBonn/Rhein – SiegKlinik für Allgemein- und Bauchchirurgie
    • Mr.  Prof.  Hans-Wilhelm  Keller 
    • Von-Hompesch-Straße 1
    • 53123  Bonn
    • Germany
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    • Marienhospital DüsseldorfDarmkrebszentrum
    • Mr.  Dr.  Konstantinos  Zarras 
    • Rochusstraße 2
    • 40479  Düsseldorf
    • Germany
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    • Pius-HospitalKlinik für Allgemein- und ViszeralchirurgieUniversitätsklinik für Viszeralchirurgie
    • Mr.  Dr.  Dirk  Weiyhe 
    • Georgstraße 12
    • 26121  Oldenburg
    • Germany
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    • Sana Klinikum Hof GmbHKlinik für Allgemein-, Viszeral- und Thoraxchirurgie
    • Prof.  Christian  Graeb 
    • Eppenreuther Straße 9
    • 95032  Hof
    • Germany
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    • Schwarzwald- Baar KlinikumVillingen-SchwenningenKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Prof.  Norbert  Runkel 
    • Klinikstraße 11
    • 78052  Villingen-Schwenningen
    • Germany
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    • St. Agnes-Krankenhaus BocholtDarmzentrum
    • Mr.  PD Dr.  Torsten  Überrück 
    • Barloer Weg 125
    • 46397  Bocholt
    • Germany
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    • St. Anna-Hospital HerneKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Dr.  Nurettin  Albayrak 
    • Hospitalstraße 19
    • 44649  Herne
    • Germany
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    • St. Barbara-Klinik Hamm-HeessenKlinik für Allgemein- und Viszeralchirurgie, Koloproktologie, Visceralmedizin, Departement für Oberbauch- und Endokrine Chirurgie, Adipositaszentrum
    • Mr.  PD Dr.  Matthias  Kraemer 
    • Am Heessener Wald 1
    • 59073  Hamm
    • Germany
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    • St. Josef-Hospital BochumKlinik für Allgemein- und Viszeralchirurgie
    • Mr.  Prof.  Waldemar  Uhl 
    • Gudrunstraße 56
    • 44791  Bochum
    • Germany
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    • St. Martinus-HospitalChirurgische Klinik
    • Mr.  Dr.  Jürgen  Bong 
    • Hospitalweg 6
    • 57462  Olpe
    • Germany
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    end of 1:1-Block address contact other
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    • St. Vincenz Krankenhaus DattelnDarmkrebszentrum
    • Mr.  Dr.  Jürgen  Mais 
    • Rottstraße 11
    • 45711  Datteln
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • St. Walburga-Krankenhaus MeschedeKlinik für Allgemein-, Viszeralchirurgie und Koloproktologie
    • Mr.  Dr.  Uwe  Zorn 
    • Schederweg 12
    • 59872  Meschede
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Westküstenklinik HeideKlinik für Viszeral-, Thorax- und Gefäßchirurgie
    • Mr.  Dr  Olaf  Liedke 
    • Esmarchstraße 50
    • 25746  Heide
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Zollernalb Klinikum AlbstadtKlinik für Viszeral- und Gefäßchirurgie
    • Mr.  Dr.  Uwe  Markert 
    • Friedrich Straße 39
    • 72458  Albstadt
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address other
    • Evangelisches Krankenhaus DüsseldorfChirurgische Klinik, Klinik für Allgemein-, Viszeral- und Gefäßchirurgie
    • Mr.  Prof.  Werner  Hartwig 
    • Kirchfeldstraße 40
    • 40217  Düsseldorf
    • Germany
    end of 1:1-Block address other
    start of 1:1-Block address contact other
    •   [---]*
    •   [---]*
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact other
  • start of 1:1-Block address scientific-contact
    • Klinik für Allgemeine-, Viszeral- und Kinderchirurgie Kliniken Böblingen, Klinikum Böblingen-Sindelfingen
    • Mr.  Prof. Dr. med.  Stefan  Benz 
    • Bunsenstr. 120
    • 71032  Böblingen
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik für Allgemeine-, Viszeral- und Kinderchirurgie Kliniken Böblingen, Klinikum Böblingen-Sindelfingen
    • Mr.  Prof. Dr. med.  Stefan  Benz 
    • Bunsenstr. 120
    • 71032  Böblingen
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik für Allgemeine-, Viszeral- und Kinderchirurgie Kliniken Böblingen, Klinikum Böblingen-Sindelfingen
    • Mr.  Prof. Dr. med.  Stefan  Benz 
    • Bunsenstr. 120
    • 71032  Böblingen
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up continuing
  •   [---]*
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  • [---]*
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.