Condition category
Cancer
Date applied
01/07/2008
Date assigned
28/08/2008
Last edited
30/06/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Martin K Schilling

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

LDD (Liver Dissection Devices)

Study hypothesis

Evaluate the surgical safety and the costs of different commercially available liver dissection devices.

Ethics approval

Ethics approval received from the local Ethical Committee of the University of the Saarland in March 2005 (ref: 47/05)

Study design

Single-centre, randomised, single-blind study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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 names

Primary outcome measures

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.

Secondary outcome measures

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.

Overall trial start date

01/09/2003

Overall trial end date

30/06/2005

Reason abandoned

Eligibility

Participant inclusion criteria

All patients undergoing liver resection for primary or secondary hepatic malignancy of any age and gender.

Participant type

Patient

Age group

Not Specified

Gender

Both

Target number of participants

96

Participant exclusion criteria

1. Cirrhosis or cholestasis (serum bilirubin greater than 25 mg/dl)
2. Prior chemotherapy (within 6 months) and multiple liver tumours

Recruitment start date

01/09/2003

Recruitment end date

30/06/2005

Locations

Countries of recruitment

Germany

Trial participating centre

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

Sponsor information

Organisation

University of Saarland (Germany)

Sponsor details

Department of General-
Visceral-
Vascular- and Paediatric Surgery
Kirrberger Strasse
Gebaeude 57
Homburg/Saar
66421
Germany

Sponsor type

University/education

Website

http://www.uni-saarland.de/en/

Funders

Funder type

Other

Funder name

Investigator initiated and funded (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2009 results on http://www.ncbi.nlm.nih.gov/pubmed/19402191

Publication citations

  1. Results

    Richter S, Kollmar O, Schuld J, Moussavian MR, Igna D, Schilling MK, , Randomized clinical trial of efficacy and costs of three dissection devices in liver resection., Br J Surg, 2009, 96, 6, 593-601, doi: 10.1002/bjs.6610.

Additional files

Editorial Notes