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 |
| Secondary identifying numbers | N/A |
- 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
Scientific
Department of General-, Visceral- , Vascular- and Paediatric Surgery
University of Saarland
Homburg/Saar
66421
Germany
Study information
| Study design | Single-centre, randomised, single-blind study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure | 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 study start date | 01/09/2003 |
| Completion date | 30/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Both |
| Target number of participants | 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
66421
Germany
Sponsor information
University of Saarland (Germany)
University/education
University/education
Department of General-, Visceral- , Vascular- and Paediatric Surgery
Kirrberger Strasse
Gebaeude 57
Homburg/Saar
66421
Germany
| Website | http://www.uni-saarland.de/en/ |
|---|---|
"ROR" |
https://ror.org/01jdpyv68 |
Funders
Funder type
Other
Investigator initiated and funded (Germany)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
