Trial document





This trial has been registered retrospectively.
drksid header

  DRKS00009810

Trial Description

start of 1:1-Block title

Title

Oncological outcome of patients with (low-risk) endometrial cancer undergoing laparotomy versus vaginal hysterectomy - a retrospective analysis

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

OPELVa

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

http://n.a.

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

Endometrial cancer is the most frequent malignancy within the gynecological field. The incidence increases with age. Especially in the western world this will lead to a dramatic increase of the incidence within the next years due to the demographic change. The relevance of therapy of this tumor entity will consequently increase. The International Federation of Gynecology and Obsterics (FIGO) recommends the total hysterectomy and bilateral salpingo-oophorectomy and lymph node dissection. A multitude of patients with endometrial cancer show major co-morbidities making a large-scaled surgical approach via laparotomy challenging of in some cases even not feasible. Consequently a vaginal approach is performed as alternatve procedure.
Aim of this retrospective study is to compare the oncological outcome of the different surgical approaches (laparotomy vs. vaginal hysterectomy), compare consequences of the two approaches and to evaluate risk factors for the correpsonding surgical approaches.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

Endometrial cancer is the most frequent malignancy within the gynecological field. The incidence increases with age. Especially in the western world this will lead to a dramatic increase of the incidence within the next years due to the demographic change. The relevance of therapy of this tumor entity will consequently increase. The International Federation of Gynecology and Obsterics (FIGO) recommends the total hysterectomy and bilateral salpingo-oophorectomy and lymph node dissection. A multitude of patients with endometrial cancer show major co-morbidities making a large-scaled surgical approach via laparotomy challenging of in some cases even not feasible. Consequently a vaginal approach is performed as alternatve procedure.
Aim of this retrospective study is to compare the oncological outcome of the different surgical approaches (laparotomy vs. vaginal hysterectomy), compare consequences of the two approaches and to evaluate risk factors for the correpsonding surgical approaches.
The Tumor register of Mecklenburg-Western Pomerania is used for patient identification. Using surgical protocols, patient charts and follow-up visitis the oncological course and complications are evaluated.

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00009810
  •   2019/07/11
  •   [---]*
  •   yes
  •   Approved
  •   A2016-0007, Ethik-Kommission an der Medizinischen Fakultät der Universität Rostock
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  •   U1111-1178-0838 
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   C54.1 -  Malignant neoplasm: Endometrium
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   Retrospective study investigating the open surgical approach for the treatment of endometrial cancer
  •   Retrospective study investigating the surgical approach via vaginal surgery for the treatment of endometrial cancer
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Non-randomized controlled trial
  •   Open (masking not used)
  •   [---]*
  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Comparison of the oncological outcome (OAS and PFS) after laparotomy vs. vagnal hysterectomy of patients with endometrial cancer

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

Identification of risk factors for laparotomic vs. vaginal approach
- surgical related complications
- length of hospital stay
- surgical time
- blood loss
- risk factors for complications
- number of previous surgeries

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • University Medical Center 
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2016/01/31
  •   100
  •   Monocenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Female
  •   18   Years
  •   90   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

all patients with histological proven endometrial cancer

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

all other tumor entities, patients without histological proven endometrial cancer

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Universitätsfrauenklinik am Klinikum Südstadt
    • Südring 81
    • 18055  Rostock
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    •   038144014500
    •   038144014500
    •   [---]*
    •   [---]*
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Universitätsfrauenklinik am Klinikum Südstadt
    • Mr.  Dr. med.  Max  Dieterich 
    • Südring 81
    • 18055  Rostock
    • 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
    • Universitätsfrauenklinik am Klinikum Südstadt
    • Mr.  PD Dr. med.  Max  Dieterich 
    • Südring 81
    • 18055  Rostock
    • 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
    • Universitätsfrauenklinik am Klinikum Südstadt
    • Mr.  Dr. med.  Max  Dieterich 
    • Südring 81
    • 18055  Rostock
    • 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 complete
  •   2019/03/10
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.