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
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
81675
Germany
Sponsor information
Ethicon Endo-Surgery (Europe) GmbH
Industry
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
