Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Economisation of Whipple Resection Using Electrosurgical Sealing Device (SEAL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00850291
Recruitment Status : Completed
First Posted : February 24, 2009
Last Update Posted : June 23, 2017
Sponsor:
Collaborator:
Medtronic - MITG
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief Summary:
Including 89 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 electrosurgical sealing device versus traditional surgical methods such as stitches an ligations.The study is performed for patients undergoing partial pancreatoduodenectomy.

Condition or disease
Duodenopancreatectomy

Layout table for study information
Study Type : Observational
Actual Enrollment : 89 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Controlled, Randomized Study of Economisation of the Preparation in Partial Duodenopancreatectomy Using an Electrosurgical Sealing Device Versus Traditional Methods
Study Start Date : May 2008
Actual Primary Completion Date : February 2010
Actual Study Completion Date : October 2010

Group/Cohort
1
Electrosurgical vessel sealing device
2
traditional surgical methods:stitches and ligations




Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients planned for partial pancreatoduodenectomy for pancreatic head carcinoma, periampullary carcinoma, chronic pancreatitis and other benign lesions.
Criteria

Inclusion Criteria:

  • resectable tumor

Exclusion Criteria:

  • palliative resection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00850291


Locations
Layout table for location information
Germany
UH Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Medtronic - MITG
Investigators
Layout table for investigator information
Principal Investigator: Jacob R. Izbicki, Prof. Dr. Universitätsklinikum Hamburg-Eppendorf

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT00850291     History of Changes
Other Study ID Numbers: 2907
First Posted: February 24, 2009    Key Record Dates
Last Update Posted: June 23, 2017
Last Verified: June 2017
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
Partial duodenopancreatectomy using electrosurgical vessel sealing device