Economisation of Whipple Resection Using an Ultrasonic Dissection Device

Completed

• Conditions: Chronic Pancreatitis; Resectable Periampullary Neoplasm; Resectable Pancreatic Head Neoplasm

• Registration Number: NCT01321450
• Lead Sponsor: Universitätsklinikum Hamburg-Eppendorf

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-03
• Study First Submitted: 2011-01-24
• Study First Submitted QC: 2011-03-21
• Study First Posted: 2011-03-23
• Primary Completion: 2011-07
• Study Completion: 2011-10
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-25
• Last Update Posted: 2019-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

Inclusion Criteria

resectable tumor

Exclusion Criteria

palliative resection

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total operation time	end of operation	Measurement of time regarding incision-closure-time

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

UH Verona; 🇮🇹 Verona, Italy

UH Eppendorf; 🇩🇪 Hamburg, Germany

Agia Olga hospital; 🇬🇷 Athens, Greece