Optimisation of anaesthetic procedures during radical retropubic prostatectomy

Not Applicable

• Conditions: C61; Malignant neoplasm of prostate

• Registration Number: DRKS00004315
• Lead Sponsor: Charité - Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Completion: 2007-12-31
• Study Start: 2012-09-17
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Male
• Target Recruitment: 265

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)

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To provide evidence that the insertion of a thoracic peridural catheter leads to a reduction of blood loss during radical retropubic prostatectomy.<br>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).<br><br><br>

Secondary Outcome Measures

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