Use of vessel sealing system (ligasure) thyroid surgery: time saving? A prospective randomised study
| ISRCTN | ISRCTN82389535 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN82389535 |
| Protocol serial number | N/A |
| Sponsor | Diakonessenhuis Hospital Utrecht (The Netherlands) |
| Funder | Diakonessenhuis Utrecht (The Netherlands) |
- Submission date
- 11/04/2007
- Registration date
- 11/04/2007
- Last edited
- 07/06/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr A Schiphorst
Scientific
Scientific
Diakonessenhuis Utrecht
Department of Surgery
P.O. Box 80250
Utrecht
3508 TG
Netherlands
| Phone | +31 (0)30 256 6242 |
|---|---|
| aschiphorst@diakhuis.nl |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised, active controlled, parallel group trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | |
| Study objectives | Use of a vessel sealing system (ligasure) in thyroid surgery reduces operation time. |
| Ethics approval(s) | Ethics approval received from the local medical ethics committee |
| Health condition(s) or problem(s) studied | Thyroidectomy |
| Intervention | Use of vessel sealing system (ligasure) versus conventional knotting for ligation of blood vessels during thyroid surgery. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure(s) |
Length of operation. |
| Key secondary outcome measure(s) |
1. Bleeding complications |
| Completion date | 01/04/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Not Specified |
| Target sample size at registration | 20 |
| Key inclusion criteria | 1. Indication for total hemithryeoidectomy 2. Age greater than 18 years 3. Informed consent |
| Key exclusion criteria | 1. American Society of Anaesthesiologists (ASA) IV and V patients |
| Date of first enrolment | 01/09/2005 |
| Date of final enrolment | 01/04/2007 |
Locations
Countries of recruitment
- Netherlands
Study participating centre
Diakonessenhuis Utrecht
Utrecht
3508 TG
Netherlands
3508 TG
Netherlands
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 | 18/01/2012 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
