Trial document




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  DRKS00003108

Trial Description

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Title

clinical Outcome and Quality of Life of patients after low anterior resection (and total mesorectal excision if Cancer is is locally spreaded)
with NiTi-Colonring

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

In this study the newer Anastomosisdevice "NiTi-Colonring" (NiTi-Surgical) shall be examined und analysed.
Patient suffering under Rectal-Cancer will be examined and asked about complications and their Quality of Life befor and after the operation.
Afterwards there will be a comparison between datas (already existing) of patients whose anastomosis is done with a "normal" device.

We want to show, that, at this operation (low anterior resection), the clinical Outcome of the Patient ist not worse than with older devices.

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Brief Summary in Scientific Language

Analysis of the clinical outcome of Patients with Rectal-Cancer, anastomosis done with NiTi-Colonring (clinical examination). Questionaire about Quality of Life before the first operation and before shift back of the Ileostoma.

To Show: non-inferior of the Colonring

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Organizational Data

  •   DRKS00003108
  •   2011/05/25
  •   [---]*
  •   yes
  •   Approved
  •   2011-247N-MA, Medizinische Ethik-Kommission II Medizinische Fakultät Mannheim der Universität Heidelberg
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Secondary IDs

  • [---]*
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Health Condition or Problem studied

  •   C20 -  Malignant neoplasm of rectum
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Interventions/Observational Groups

  •   monitoring group: patients with low anterior resection, Anastomosis with NiTi-Colonring.

    Questionaires about Quality of Life from the EORTC (European Organisation for Research and Treatment of Cancer)
    Moduls: QLQ C30, Cr29

    Time of questioning: directly before the first operation (low anterior resection with anastomosis) and directly befor the shift back of the ileostoma
  •   historical reference group: Datas of the database of the surgical section of the university medical centre about Patients with low anterior resection, anastomosis done with normal staple-device
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Characteristics

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

Anastomosisinsufficiency during a 3month period of surveillance

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Secondary Outcome

time till bowel and bladder work again, first tolerated food (both liquid and solid), equipment malfunctions during operation, bleeding, stricture, septical complication,
and recurrence of Cancer, re-operation oder death within 30days after operation, Quality of Life (EORTC QLQ C30, CR29)

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • [---]*
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Recruitment

  •   Actual
  •   2011/06/01
  •   30
  •   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

Rectal-Resection (with or without total mesorectal excision) and anastomosis done with NiTi-Colonring

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Exclusion Criteria

Patient younger than 18 years

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Addresses

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    • Chirurgische Klinik Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    •   [---]*
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    • Chirurgische Klinik Universitätsmedizin Mannheim
    • Mr.  Prof. Dr. med  Peter  Kienle 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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    • Chirurgische Klinik Universitätsmedizin Mannheim
    • Mr.  Prof. Dr. med  Peter  Kienle 
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Sources of Monetary or Material Support

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    • Chirurgische Klinik, Universitätsmedizin Mannheim
    • Theodor-Kutzer-Ufer 1-3
    • 68167  Mannheim
    • Germany
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Status

  •   Recruiting stopped after recruiting started
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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.