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 |
| Protocol serial number | N/A |
| Sponsor | Ethicon Endo-Surgery (Europe) GmbH |
| Funder | Ethicon Endo-Surgery (Europe) GmbH |
- 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
Scientific
Chirurgische Klinik und Poliklinik
Klinikum rechts der Isar
Ismaningerstr. 22
Munich
81675
Germany
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Prospective, two-arm, randomised, controlled clinical study |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Reduction of operation time for total gastrectomy/colon resection with WAVE ultrasound dissector. |
| Key secondary outcome measure(s) |
1. Reduction of intra-operative blood loss |
| Completion date | 31/03/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 200 |
| 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
81675
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
13/09/2017: internal review
