Clinical relevance study for a novel ultrasonic dissection cutter versus conventional mobilisation/dissection in open stomach and colon procedures

ISRCTN	ISRCTN97779420
DOI	https://doi.org/10.1186/ISRCTN97779420
Secondary identifying numbers	N/A

Submission date: 15/01/2008
Registration date: 28/11/2008
Last edited: 13/09/2017

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Hubertus Feußner
Scientific

Chirurgische Klinik und Poliklinik
Klinikum rechts der Isar
Ismaningerstr. 22
Munich
81675
Germany

Study information

Study design	Prospective, two-arm, randomised, controlled clinical study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet.
Scientific title	Clinical relevance study for a novel ultrasonic dissection cutter versus conventional mobilisation/dissection in open stomach and colon procedures - a randomised controlled study
Study objectives	In technically demanding visceral operations such as gastrectomy and colon resection, precision and a mobilisation technique with little or no bleeding are of special significance. The hypothesis is that WAVE ultrasonic technology is particularly suitable for reducing the total operating time because it generates very little heat in the surrounding tissue, enabling safe, atraumatic surgical dissection in combination with simultaneous haemostasis.
Ethics approval(s)	Received from the Ethics Review Board (ERB) of Klinikum rechts der Isar on the 18th October 2007
Health condition(s) or problem(s) studied	Gastric carcinoma, colon carcinoma
Intervention	Treatment Arm A (WAVE ultrasound dissector): The operation is performed as described in the surgical report. The WAVE ultrasound dissector is exclusively used for dissection and coagulation. Treatment Arm B (conventional mobilisation/dissection): The operation is performed as described in the surgical report. Dissection and coagulation are performed exclusively with instruments using mono- and bi-polar current or ligatures/stitches. The follow up will take place during the whole in-hospital stay of the patient.
Intervention type	Other
Primary outcome measure	Reduction of operation time for total gastrectomy/colon resection with WAVE ultrasound dissector.
Secondary outcome measures	1. Reduction of intra-operative blood loss 2. Reduction of the quantity of drainage secretion and dwell time of the drain 3. Comparison of oncological (surgical margins) and functional outcomes between the different methods
Overall study start date	15/12/2007
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	200 (100 in each arm)
Key inclusion criteria	1. Gastric carcinoma, colon carcinoma 2. Patient's written declaration of informed consent after being given written and oral information 3. General status: operable according to American Society of Anaesthesiologists (ASA) categorisation of the risks of anaesthetic 4. Age over 18, either sex
Key exclusion criteria	1. Enrolment in other clinical trials that might interfere with the present study 2. Refusal of consent to the storage and communication of anonymised medical history data, previous psychiatric illness or other circumstances that might compromise the patient's co-operation Exclusion of patients after enrolment in the trial: 1. Inoperability during the procedure; change of planned procedure 2. Wthdrawal of consent
Date of first enrolment	15/12/2007
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Austria
Germany
Hungary
Italy

Study participating centre

Chirurgische Klinik und Poliklinik

Munich
81675
Germany

Sponsor information

Ethicon Endo-Surgery (Europe) GmbH
Industry

Hummelsbütteler Steindamm 71
Norderstedt
22851
Germany

Website	http://www.ethiconendo.com/
"ROR"	https://ror.org/023edjq13

Funders

Funder type

Industry

Ethicon Endo-Surgery (Europe) GmbH

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/02/2011		Yes	No

Editorial Notes

13/09/2017: internal review