Cost and efficacy of dissection devices in extended and parenchyma preserving liver resection: a prospective randomised trial

ISRCTN	ISRCTN52294555
DOI	https://doi.org/10.1186/ISRCTN52294555
Protocol serial number	N/A
Sponsor	University of Saarland (Germany)
Funder	Investigator initiated and funded (Germany)

Submission date: 01/07/2008
Registration date: 28/08/2008
Last edited: 30/06/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Martin K Schilling
Scientific

Department of General-, Visceral- , Vascular- and Paediatric Surgery
University of Saarland
Homburg/Saar
66421
Germany

Study information

Primary study design	Interventional
Study design	Single-centre, randomised, single-blind study
Secondary study design	Randomised controlled trial
Scientific title
Study acronym	LDD (Liver Dissection Devices)
Study objectives	Evaluate the surgical safety and the costs of different commercially available liver dissection devices.
Ethics approval(s)	Ethics approval received from the local Ethical Committee of the University of the Saarland in March 2005 (ref: 47/05)
Health condition(s) or problem(s) studied	Primary or secondary hepatic malignacy
Intervention	Liver resection with three different liver resection (dissection) devices: 1. Selector® (Erbe, Tübingen, Germany) 2. Helix HydroJet® (Erbe, Tübingen, Germany) 3. Dissecting Sealer 3.0® (TissueLink Medical, Dover, NH, USA) Total duration of follow-up in all treatment arms was until discharge from hospital, no further follow up was performed.
Intervention type	Device
Phase	Not Specified
Drug / device / biological / vaccine name(s)
Primary outcome measure(s)	1. Blood loss 2. Intraoperative and postoperative blood transfusions 3. Dissection time 4. Resection area 5. Dissection speed 6. Blood loss per dissected area 7. Post-operative International Normalised Ratio (INR) 8. Post-operative partial thromboplastin time (PTT) 9. Post-operative bilirubin levels 10. Morbidity (bleeding, bile fistula, cholangitis, liver abscess, pleura effusion, pneumonia, cardiac complications) 11. Intensive Care Unit (ICU) stay 12. Hospital stay Primary and secondary outcomes were measured during the hospital stay.
Key secondary outcome measure(s)	1. Mounting time 2. Costs of devices (system costs) 3. Maintenance costs 4. Costs of additional haemostyptic items 5. Costs of staplers and magazines Primary and secondary outcomes were measured during the hospital stay.
Completion date	30/06/2005

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	All
Target sample size at registration	96
Key inclusion criteria	All patients undergoing liver resection for primary or secondary hepatic malignancy of any age and gender.
Key exclusion criteria	1. Cirrhosis or cholestasis (serum bilirubin greater than 25 mg/dl) 2. Prior chemotherapy (within 6 months) and multiple liver tumours
Date of first enrolment	01/09/2003
Date of final enrolment	30/06/2005

Locations

Countries of recruitment

Germany

Study participating centre

Department of General-, Visceral- , Vascular- and Paediatric Surgery

Homburg/Saar
66421
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2009		Yes	No