Trial document





This trial has been registered retrospectively.
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  DRKS00013790

Trial Description

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Title


Retrospective monocentric study to investigate the influence of BMI on laparoscopic gynecological surgical procedures with regard to intraoperative and postoperative parameters and complications

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

Retrospectively descriptive peri- and postoperative parameters, as well as complications and postoperative outcome of patients undergoing laparoscopic surgery are collected. The classification of the weight classes in normal weight with BMI of 18.5 to 25, overweight with BMI> 25, obesity grade 1 with BMI of 30-35, obesity grade 2 with BMI of 35-40 and obesity grade 3 with BMI> 40 .The influence of the various BMI classes with regard to intraoperative and postoperative complications and postoperative outcome is to be determined

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Brief Summary in Scientific Language

Previous work on minimally invasive therapy has shown that this offers far more advantages than open-surgical procedures. Especially with regard to intraoperative and postoperative complications, blood loss and postoperative length of stay, laparoscopic procedures are superior to open procedures. Insufficient the data is still in the range of the influence of BMI on peri- and postoperative complications and postoperative outcome. If there are no significant differences between normal-weight and obese patients undergoing laparoscopic surgery, this would be a gain in evidence for the safety of minimally invasive procedures.

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Do you plan to share individual participant data with other researchers?

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Description IPD sharing plan:

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Organizational Data

  •   DRKS00013790
  •   2018/05/14
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  •   yes
  •   No approval required according to EC
  •   19/18, Ethik-Kommission bei der Ärztekammer des Saarlandes
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Secondary IDs

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Health Condition or Problem studied

  •   E66 -  Obesity
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Interventions/Observational Groups

  •   The period 08/2010 to 09/2017 is investigated. During this period, all patients who undergo a laparoscopic operation at the abovementioned facility will be analyzed retrospectively by a prospective database. It is divided into three BMI classes (BMI < 25, BMI > 25 and BMI > 30). Surgical parameters and post-operative complications are analyzed.
  •   BMI < 25
  •   BMI > 25
  •   BMI > 30
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Characteristics

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

intra- and postoperative complications

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Secondary Outcome


Secondary outcomes include surgical duration, CO² consumption, HB drop, intraoperative and postoperative parameters and complications, postoperative length of stay. These parameters are extracted by means of retrospective data research from digitized and archived medical records.

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/02/26
  •   3000
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Female
  •   no minimum age
  •   no maximum age
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Additional Inclusion Criteria

All patients who have undergone a laparoscopic gynecological therapy at the University Women's Hospital Homburg from 01.08.2010 are included.

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Exclusion Criteria

1. Laparoscopy assisted vaginal hysterectomy
2. Incomplete data

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Addresses

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    • Universitätsklinikum des Saarlandes
    • 66421  Homburg/Saar
    • Germany
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    • Universitätsfrauenklinik Homburg
    • Ms.  Dr.  Julia  Radosa 
    • Kirrberger Straße, Gebäude 9
    • 66421  Homburg
    • Germany
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    • Universitätsfrauenklinik Homburg
    • Ms.  Dr.  Julia  Radosa 
    • Kirrberger Straße, Gebäude 9
    • 66421  Homburg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsfrauenklinik Homburg
    • Mr.  Prof. Dr. med.  Erich-Franz  Solomayer 
    • Kirrberger Straße, Gebäude 9
    • 66421  Homburg
    • Germany
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Status

  •   Recruiting ongoing
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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.