Monopolar Scissors vs Bipolar Vessel Sealer vs Ultrasonic... | NCT00517608

Studies
Monopolar Scissors vs Bipolar Vessel Sealer vs Ultrasonic Shears: A Prospective Randomized Study in Laparoscopic Colorectal Surgery

NCT00517608

Sponsor

University of Zurich

Status

Completed

Last Update Posted

Aug 21, 2007Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Colorectal Disease

Interventions

Laparoscopic colectomy

Countries

Switzerland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2005

Primary Completion Date

Not provided

Completion Date

Dec 2006Actual

First Submitted Date

Aug 16, 2007

First Submission Date that Met QC Criteria

Aug 16, 2007

First Posted Date

Aug 17, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2007

Last Update Posted Date

Aug 21, 2007Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Monopolar electro surgery scissors (MES), electro thermal bipolar vessel sealer (BVS) and ultrasonically coagulating shears (UCS) are all applied in laparoscopic colorectal surgery. We aimed to compare the different devices with regard to dissection time, blood loss, technical aspects and costs.

Trial with surgical intervention

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
Laparoscopic colectomy	Device

Measure	Description	Time Frame
Dissection time

Eligibility Module

Eligibility Criteria

Inclusion criteria: All patients undergoing laparoscopic left-sided colorectal resection.

Exclusion criteria: < 18 years no informed consent restricted communication abilities (language, mental illness)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

95 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
01 Studienregister MasterAdmins	UniversitaetsSpital Zuerich	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital of Zurich		Zurich			Switzerland

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18690630	Derived	Hubner M, Demartines N, Muller S, Dindo D, Clavien PA, Hahnloser D. Prospective randomized study of monopolar scissors, bipolar vessel sealer and ultrasonic shears in laparoscopic colorectal surgery. Br J Surg. 2008 Sep;95(9):1098-104. doi: 10.1002/bjs.6321.