Optimisation of anaesthetic procedures during radical retropubic prostatectomy

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

DRKS

Registry ID

DRKS00004315

Enrollment

230

Registered

2012-09-17

Start date

2005-01-03

Completion date

Unknown

Last updated

2025-04-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

C61

Interventions

Group 1: Radical retropubic prostatectomy with extended pelvic lymphadenectomy in a 25-30° Trendelenburg position with general anesthesia combined with a thoracic peridural catheter Group 2: Radical r

Eligibility

Sex/Gender

Male

Age

18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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).	—

Measure

Time frame

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).

—

Secondary

Measure	Time frame
- 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	—

Measure

Time frame

- 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

—

Countries

Germany

Contacts

Public ContactDaniel Baumunk

Universitätsklinikum Magdeburg A. ö. R.

daniel.baumunk@med.ovgu.de00493916713337

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026