Condition category
Cancer
Date applied
15/01/2008
Date assigned
28/11/2008
Last edited
02/02/2011
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Hubertus Feußner

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

Received from the Ethics Review Board (ERB) of Klinikum rechts der Isar on the 18th October 2007

Study design

Prospective, two-arm, randomised, controlled clinical study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet.

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

15/12/2007

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200 (100 in each arm)

Participant 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

Recruitment start date

15/12/2007

Recruitment end date

31/03/2009

Locations

Countries of recruitment

Austria, Germany, Hungary, Italy

Trial participating centre

Chirurgische Klinik und Poliklinik
Munich
81675
Germany

Sponsor information

Organisation

Ethicon Endo-Surgery (Europe) GmbH

Sponsor details

Hummelsbütteler Steindamm 71
Norderstedt
22851
Germany

Sponsor type

Industry

Website

http://www.ethiconendo.com/

Funders

Funder type

Industry

Funder name

Ethicon Endo-Surgery (Europe) GmbH

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21165924

Publication citations

  1. Results

    Wilhelm D, Szabo M, Glass F, Schuhmacher C, Friess H, Feussner H, Randomized controlled trial of ultrasonic dissection versus standard surgical technique in open left hemicolectomy or total gastrectomy., Br J Surg, 2011, 98, 2, 220-227, doi: 10.1002/bjs.7354.

Additional files

Editorial Notes