Trial document





This trial has been registered retrospectively.
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  DRKS00004315

Trial Description

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Title

Optimisation of anaesthetic procedures during radical retropubic prostatectomy

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Trial Acronym

[---]*

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URL of the Trial

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Brief Summary in Lay Language

Background: Removal of the prostate due to prostate cancer is associated with the risk of bleeding which could lead to undesirable side effects and could therefore have a strong impact on patients outcome.

Improvement of the anaesthetic procedures could possibly lead to a reduction of blood loss during radical prostatectomy. A peridural catheter is a small plastic tube which can be inserted into the so-called peridural space which surrounds the spinal cord. During narcosis it is possible to continously administer analgetics through the peridural catheter. This directed administration also leads to a reduction of the mean arterial blood pressure. Therefore the insertion of a peridural catheter may positively influence the blood loss during radical retropubic prostatectomy.
The insertion of a peridural catheter is a standard anaesthetic procedure in many abdominal operations and is for example used for pain management at birth.

Study design: To evaluate the influence of the peridural catheter on blood loss during radical retropubic prostatectomy, two groups were formed: receiving the identical narcosis and identical operation, patients of group 1 received a thoracic peridural catheter for administration of analgetics; patients of group 2 received analgesia through a peripheral vein.

Haemoglobin levels were measured on the day before surgery, on the first postoperative day and one day before discharge. There were no additional blood takings due to the study.
In addition the intraoperative blood loss was measured by the volume of the surgical aspirator and by weighing out the intraoperatively used surgical drapes. Haemoglobin was measured daily in the wound drainage secretion until removal of the drainage.
Another parameter of interest indicating the renal function was serum creatinine.

In order to monitor intraoperative anaesthetic parameters four phases during the operation were defined: Phase A: beginning of narcosis to skin incision; Phase B: skin incision and pelvic lymphadenectomy; Phase C: preparation of the prostate until removal of the specimen; Phase D: removal of the specimen until the end of the operation. According to the phases the following parameters were documented: total amount of infusions and type of infusion, blood pressure - particularly the mean arterial pressure- heart rate and body temperature. Independently from the insertion of a peridural catheter, the purpose of the narcosis was to reach a mean arterial pressure between 60-70 mmHg and to avoid an overload of the blood vessels by too much infusion.

Participants: All patients qualifying for radical retropubic prostatectomy between 18 and 75 years who gave their written informed consent and hit the inclusion criteria (see below). There may not be any contraindications for the insertion of a peridural catheter nor any of the exclusion criteria (see below).

Aim/ Hypothesis of the study: The insertion of a peridural catheter leads to a reduction in blood loss in radical retropubic prostatectomy.

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Brief Summary in Scientific Language

Prospective randomized trial to evaluate the influence of a thoracic peridrual catheter on blood loss at retropubic radical prostatectomy

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Organizational Data

  •   DRKS00004315
  •   2012/09/17
  •   [---]*
  •   yes
  •   Approved
  •   226-06, Ethik-Kommission der Charité -Universitätsmedizin Berlin-
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Secondary IDs

  •   U1111-1141-2000 
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Health Condition or Problem studied

  •   C61 -  Malignant neoplasm of prostate
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Interventions/Observational Groups

  •   Radical retropubic prostatectomy with extended pelvic lymphadenectomy in a 25-30° Trendelenburg position with general anesthesia combined with a thoracic peridural catheter
  •   Radical retropubic prostatectomy with extended pelvic lymphadenectomy in a 25-30° Trendelenburg position with general anesthesia alone
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Characteristics

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

To provide evidence that the insertion of a thoracic peridural catheter leads to a reduction of blood loss during radical retropubic prostatectomy.
Measurements: 1. haemoglobin difference between the day before surgery and the first postoperative day; 2. intraoperative blood loss, assessed by a) volume of the surgical aspirator and b) weighing of the intraoperatively used surgical drapes; 3. daily measurement of the haemoglobin in the drainage secretion until removement of drainage; 4. haemoglobin one day before discharge (normally days 4-7).


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Secondary Outcome

- duration of the operation: Measurement in minutes from skin incision to skin suture
- oncosurgical results: TNM status and R status according to histopathological findings with a focus on R1-resections in correlation to TNM status
- duration of hospitalization: measurement in days
- documentation of all undesirable side effects, especially:
- thrombosis
- pulmonary embolism
- rectal injury
- injury to nerves
- acute renal failure
- myocardial ischemia or infarction

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  • University Medical Center 
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Recruitment

  •   Actual
  •   2005/01/03
  •   230
  •   Monocenter trial
  •   National
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Inclusion Criteria

  •   Male
  •   18   Years
  •   75   Years
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Additional Inclusion Criteria

- eligible for radical retropubic prostatectomy
- age between 18 and 75 years
- Charlson Comorbidity Score ≤ 1 or ASA < III
- written informed consent according to the declaration of Helsinki (Hongkong 1989)
- operation by a highly experienced surgeon (e. g. 50 RPX, 30 OPs/year)

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Exclusion Criteria

- substantial comorbidities
- Charlson Comorbidity Score >1 or ASA >II
- substantial comorbidities which should be operated within same narcosis (e. g. hemicolektomy)
- clotting disorders
- degeneration of the lumbar spine or other contraindications against the insertion of a thoracic peridural catheter
- not able or not willing to sign the informed consent
- known alcohol- or drug abuse
- every other circumstance/ condition that makes the participation of the individual in the study inappropriate

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Addresses

  • start of 1:1-Block address primary-sponsor
    • Charité - Universitätsmedizin Berlin
    • Mr.  Prof. Dr. med.  Martin  Paul 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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    • Universitätsklinikum Magdeburg A. ö. R.
    • Mr.  Prof. Dr. med.  Martin  Schostak 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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    • Universitätsklinikum Magdeburg A. ö. R.
    • Mr.  Dr. med.  Daniel  Baumunk 
    • Leipziger Strasse 44
    • 39120  Magdeburg
    • Germany
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Sources of Monetary or Material Support

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    • Charité - Universitätsmedizin Berlin
    • Mr.  Prof. Dr. med.  Martin  Paul 
    • Charitéplatz 1
    • 10117  Berlin
    • Germany
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Status

  •   Recruiting complete, follow-up complete
  •   2007/12/31
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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.