Economisation of Whipple Resection Using Electrosurgical Sealing Device

NCT ID: NCT00850291

Last Updated: 2017-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

89 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-05-31

Study Completion Date

2010-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Duodenopancreatectomy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1

Electrosurgical vessel sealing device

No interventions assigned to this group

2

traditional surgical methods:stitches and ligations

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* resectable tumor

Exclusion Criteria

* palliative resection
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medtronic - MITG

INDUSTRY

Sponsor Role collaborator

Universitätsklinikum Hamburg-Eppendorf

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jacob R. Izbicki, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Universitätsklinikum Hamburg-Eppendorf

Locations

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UH Eppendorf

Hamburg, , Germany

Site Status

Countries

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Germany

References

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Ujiki MB, Talamonti MS. Guidelines for the surgical management of pancreatic adenocarcinoma. Semin Oncol. 2007 Aug;34(4):311-20. doi: 10.1053/j.seminoncol.2007.05.004.

Reference Type BACKGROUND
PMID: 17674959 (View on PubMed)

Uzunoglu FG, Bockhorn M, Fink JA, Reeh M, Vettorazzi E, Gawad KA, Bogoevski D, Vashist YK, Tsui TY, Koenig A, Mann O, Izbicki JR. LigaSure vs. conventional dissection techniques in pancreatic surgery--a prospective randomised single-centre trial. J Gastrointest Surg. 2013 Mar;17(3):494-500. doi: 10.1007/s11605-012-2107-z. Epub 2012 Dec 19.

Reference Type DERIVED
PMID: 23250820 (View on PubMed)

Other Identifiers

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2907

Identifier Type: -

Identifier Source: org_study_id

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