Trial document




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  DRKS00013763

Trial Description

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Title

Placement of Abdominal Drain Versus No Placement of Abdominal Drain After Open or Closed Pancreatic Left Resection


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Trial Acronym

PANDRA II

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URL of the Trial

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Brief Summary in Lay Language

The placement of prophylactic intraabdominal drains has been common practice in abdominal surgery. The rationale for inserting drains following surgery was that the drains were thought to evacuate fluids that may accumulate after surgery. However, up to now there is no evidence that the use of drains might reduce the risk for bearing complications after surgery and might be beneficial for patients after abdominal surgery. The aim of the present study was to evaluate the outcome after open or closed pancreatic left resection according to the presence or absence of prophylactic abdominal cavity drainage. Specific outcome endpoints were postoperative complications.

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Brief Summary in Scientific Language

Nowadays it is a common practice to place prophylactic intraabdominal drains at the end of an abdominal surgery. The rationale for inserting drains following surgery was that the drains were thought to evacuate fluids that may accumulate after surgery. However, up to now there is no evidence that the use of drains might reduce the risk for bearing complications after surgery and might be beneficial for patients after abdominal surgery. The aim of the present study was to evaluate the outcome after open or closed pancreatic left resection according to the presence or absence of prophylactic abdominal cavity drainage. Specific outcome endpoints were postoperative complications.

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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

  •   DRKS00013763
  •   2018/03/06
  •   [---]*
  •   yes
  •   Approved
  •   S-675/2017, Ethik-Kommission I der Medizinischen Fakultät Heidelberg
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Secondary IDs

  •   U1111-1207-3031 
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Health Condition or Problem studied

  •   D37.70 -  [generalization D37.7: Neoplasm of uncertain or unknown behaviour: Other digestive organs]
  •   C25 -  Malignant neoplasm of pancreas
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Interventions/Observational Groups

  •   A closed-suction drain will be placed near the transection margin at the end of an open or closed pancreatic left resection
  •   A closed-suction drain will not be placed near the transection margin at the end of an open or closed pancreatic left resection
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   N/A
  •   N/A
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Primary Outcome

Evaluation of the Comprehensive Complication Index (CCI) by measuring all complications after open or closed pancreatic left resection (time frame: 90 days) by using the Clavin Dindo Classification

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Secondary Outcome

Measuring the rate of:

pancreatic fistula according to the definition of the ISGPS 2017,

lymphatic fistula according to the definition of the ISGPS 2017,

postoperative bleedings according to the definition of the ISGPS 2007 (including arrosion bleeding),

reinterventions and reoperations including CT guided placement of drains due to intraabdominal fluid collection, intraabdominal bleeding and/or pancreatic- and lymphatic fistula,

delayed gastric emptying according to the definition of the ISGPS 2007,

intraabdominal fluid collections and/or,

intraabdominal abscess,

wound infections,

abdominal fasica dehiscences.


Measuring the:

duration of hospital/ICU stay,

rate of readmission after discharge from hospital (up to day 90 after surgery),

mortality (time frame: 90 days after surgery)


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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2018/04/09
  •   252
  •   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

surgical indication for open or closed distal pancreatectomy, at least 18 years of age, ability of subject to understand character and individual consequences of the clinical trial, written informed consent

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Exclusion Criteria

The subject has a surgical indication for pancreatic resection with a pancreaticojejunal anastomosis, American Society of Anesthesiologists (ASA) physical status classification ≥ IV, the subject is not willing to consent to randomization, impaired mental state or language problems of the subject, participation in another intervention-trial with interference of intervention and outcome of this study

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Addresses

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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    • Klinik für Allgemein-, Viszeral- und TransplantationschirurgieUniversitätsklinikum Heidelberg
    • Mr.  Prof. Dr. med.  Thilo  Hackert 
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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    • Klinisches Studienzentrum (KSC)Klinik für Allgemein-, Viszeral- und Transplantationschirurgie Universitätsklinikum Heidelberg
Ärztliche Leitung: PD Dr. Phillip Knebel
    • Im Neuenheimer Feld 110
    • 69120  Heidelberg
    • Germany
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Sources of Monetary or Material Support

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    • Universitätsklinikum Heidelberg
    • Im Neuenheimer Feld 672
    • 69120  Heidelberg
    • Germany
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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