Economisation of Whipple Resection Using an Ultrasonic Dissection Device
Sponsor
Universitätsklinikum Hamburg-Eppendorf (Other)
Overall Status
Completed
CT.gov ID
NCT01321450
Collaborator
(none)
82
3
31
27.3
0.9
Study Details
Study Description
Brief Summary
Including 150 randomised patient, the studies aim is to determine whether an economisation and/or improvement in terms of operating time, drainage fluid, blood loss, time of hospitalisation can be found using an ultrasonic dissection device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
|
Study Design
Study Type:
Observational
Actual Enrollment
:
82 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Economisation of Preparation by Using an Ultrasonic Dissection Device in Partial Pancreatoduodenectomy
Actual Study Start Date
:
Mar 1, 2009
Actual Primary Completion Date
:
Jul 1, 2011
Actual Study Completion Date
:
Oct 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Group A Preparation with Harmonic WAVE |
|
| Group B Preparation with conventional modalities |
Outcome Measures
Primary Outcome Measures
- Total operation time [end of operation]
Measurement of time regarding incision-closure-time
Secondary Outcome Measures
- intraoperative blood loss [end of operation]
- number of transfusions [within the first 24 hours perioperatively]
- hospitalization time [end of hospitalization]
- resulting cost reduction [end of hospitalization]
- pancreatic fistula [within the first 5 days postoperatively]
- postoperative intervention [end of hospitalization]
Postoperative interventions due complications, e.g. pancreatic fistula
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
resectable tumor
Exclusion Criteria:
palliative resection
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | UH Eppendorf | Hamburg | Germany | 22529 | |
| 2 | Agia Olga hospital | Athens | Greece | ||
| 3 | UH Verona | Verona | Italy | 37134 |
Sponsors and Collaborators
- Universitätsklinikum Hamburg-Eppendorf
Investigators
- Principal Investigator: Jacob R. Izbicki, Prof. Dr., Universitätsklinikum Hamburg-Eppendorf
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- Hruby GW, Marruffo FC, Durak E, Collins SM, Pierorazio P, Humphrey PA, Mansukhani MM, Landman J. Evaluation of surgical energy devices for vessel sealing and peripheral energy spread in a porcine model. J Urol. 2007 Dec;178(6):2689-93. Epub 2007 Oct 22.
- Nicastri DG, Wu M, Yun J, Swanson SJ. Evaluation of efficacy of an ultrasonic scalpel for pulmonary vascular ligation in an animal model. J Thorac Cardiovasc Surg. 2007 Jul;134(1):160-4.
- Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. Review.
Responsible Party:
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01321450
Other Study ID Numbers:
- 2908
First Posted:
Mar 23, 2011
Last Update Posted:
Jan 29, 2019
Last Verified:
Jan 1, 2019
Additional relevant MeSH terms: