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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN97779420
Enrollment
200
Registered
2008-11-28
Start date
2007-12-15
Completion date
Unknown
Last updated
2017-10-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Gastric carcinoma, colon carcinoma Cancer Gastric carcinoma

Interventions

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. Treatme

Sponsors

Ethicon Endo-Surgery (Europe) GmbH
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
Reduction of operation time for total gastrectomy/colon resection with WAVE ultrasound dissector.

Secondary

MeasureTime frame
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

Countries

Austria, Germany, Hungary, Italy

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026