Cognitive Outcome After Two-stage Liver-Operation (2-StaLi)

Charité University Medicine Berlin

Status: Terminated

Conditions: Delirium and Post-operative Cognitive Dysfunction (POCD)

Study type: Observational

Funder types: Other

Identifiers

NCT01809782

Two-stage liver

Details and patient eligibility

About

Cognitive outcome (delirium and post-operative cognitive deficiency) in patients undergoing two-time liver resection.

Enrollment: 23 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

Study Group:

Inclusion Criteria:

• Patients undergoing a planned elective in situ split liver operation with following resection after approximately ten days with or without additional elective surgery in the same session at the University Hospital, Campus Virchow-Klinikum of the Charité - University Medicine Berlin
• Patients aged greater than or equal to 18 years
• Patients of both genders
• Offered patient information and written informed consent
• No participation in another clinical trial according to the German Drug Law (AMG) during the trial and one month before inclusion

Exclusion Criteria:

• Lacking willingness to save and hand out pseudonymised data within the clinical study
• Accommodation in an institution due to an official or judicial order
• Staff of Charite University hospital Berlin, Virchow Klinikum
• Illiteracy
• Unability of German language use
• Visual and acoustical impairment
• core on the mini mental state examination (MMSE) at screening of 23 or less
• American Society of Anaesthesiologists (ASA) Classification greater than IV
• Ascertained psychiatric disease
• Intake of psychotropic drugs (including sleeping pills and Benzodiazepine)
• Symptomatic bradycardia
• Symptomatic heart rhythm disorder (arrhythmia)
• Coronary heart disease Canadian Society of Anaesthesiologists criteria (CSC) stadium IV or the presentation of a coronary heart disease that needs intervention

Control Group:

Inclusion criteria:

•Male and female ASA II/III patients, aged ≥ 18 years

Exclusion Criteria:

• Mini-Mental-State-Examination ≤ 23 Points
• Neuropsychiatric morbidity, which limits the conduction of the neurocognitive testing
• Taking psychothropic drugs (including sleep-inducing drug and benzodiazepine) on a regular basis

Trial design

23 participants in 2 patient groups

Study group:20 patients undergoing two stage liver-operation

Description:

Patients undergo two liver operations.First surgery: insitu-split for induction of proliferation in the remaining liver tissue; Second surgery: resection of the liver Tumor (4 cognitive measurements: Baseline, 7 days, 3 months and 1 year)

Control group: 20 patients (ASA class II/III)

Description:

Relatives from study personel or patients from outpatient clinics from Charité in Berlin and surrounding area (4 cognitive measurements: Baseline, 7 days, 3 months and 1 year)