Mesenteric Vessel Sealing by Three Instruments

Not Applicable

Completed

• Conditions: Surgery
• Interventions: Device: LOTUS; Device: Ethicon Harmonic Scalpel; Device: LigaSure bipolar vessel sealing device

• Registration Number: NCT01121614
• Lead Sponsor: University Hospital Plymouth NHS Trust

Brief Summary

Ultrasonic cutting-coagulation devices (UCCD) are surgical instruments which use ultrasonic energy to cut through and coagulate tissue. An Ethicon version (trademarked "Harmonic Scalpel" and "Ultracision") is used in a variety of surgical procedures. Its surgical performance has been directly compared with that of electrically powered diathermy instruments in animal and clinical trials. LOTUS is a company based in Ashburton, Devon, which has developed a UCCD that works in a slightly different way to the Harmonic Scalpel. There are also bipolar feedback diathermy instruments which use electrical energy to seal blood vessels, such as LigaSure. The aim of this project is to obtain data to design a fully powered trial to answer the research question: do LOTUS and Ethicon UCCDs and LigaSure bipolar device reliably seal and divide blood vessels? The investigators will also be examining the degree of collateral tissue damage caused by each instrument.

Hypotheses

* LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure are equivalent at sealing and dividing mesenteric blood vessels.

* LOTUS UCCD, Ethicon Harmonic Scalpel and LigaSure cause equal amount of collateral damage when sealing and dividing blood vessels.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-04
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Study First Submitted: 2010-05-07
• Study First Submitted QC: 2010-05-11
• Study First Posted: 2010-05-12
• Status Verified: 2012-07
• Last Update Submitted: 2012-07-05
• Last Update Posted: 2012-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• Patient undergoing laparoscopic or open colorectal resection

Exclusion Criteria

• Pregnant or lactating women
• Patients under eighteen years of age
• History of coagulation abnormality
• Inability to understand the nature of the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
LOTUS	LOTUS	LOTUS ultrasonic instrument
Ethicon Harmonic Scalpel	Ethicon Harmonic Scalpel	Ultrasonic instrument
LigaSure	LigaSure bipolar vessel sealing device	Bipolar feedback vessel sealing device

Primary Outcome Measures

Name	Time	Method
Bursting pressure of sealed vessel	1 day	Designated instrument is used to seal and divide a blood vessel which has been dissected from large bowel mesentery. The pressure at which the seal leaks is measured using a pressure transducer, this is known as the "bursting pressure"

Secondary Outcome Measures

Name	Time	Method
Success/failure to seal vessel	1 day	Instrument is used to seal and divide a blood vessel, this outcome is to see whether the seal is complete
Depth of collateral damage	After histological fixation is complete; within one week	Energy-based surgical instruments cause a certain amount of thermal damage to the surrounding tissue, to compare the 3 instruments this depth of damage will be measured histologically

Trial Locations

Locations (1)

Derriford Hospital; 🇬🇧 Plymouth, Devon, United Kingdom