Port fixity during laparoscopic surgery; a randomised comparison of cutting and blunt induction of secondary ports
| ISRCTN | ISRCTN44438769 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN44438769 |
| Secondary identifying numbers | N0453168843 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 30/04/2010
- 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
Mr Basil Ammori
Scientific
Scientific
MRI Central Manchester & Manchester Children's University Hospitals
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
| Phone | +44 (0)161 276 3510 |
|---|---|
| basil.ammori@cmmc.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | |
| Study objectives | To compare cutting and conical mechanisms for port induction with regard to port fixity to the abdominal wall during laparoscopic surgery. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Surgery: Laparoscopy |
| Intervention | Group 1: 5mm and 10mm ports with cutting trocars and smooth shaft Group 2: 5mm and 10mm ports with conical trocars and smooth shaft |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The traction required to partially withdraw the secondary 5mm and 10mm port from the abdominal wall is measured using purpose designed device. The measurements will be taken at the beginning of surgery and every 30mins thereafter until completion of the operation. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/05/2003 |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 50 patients will be consented and the study will compare 50 5mm ports and 50 10mm ports in each group. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/05/2003 |
| Date of final enrolment | 01/05/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
MRI Central Manchester & Manchester Children's University Hospitals
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Central Manchester and Manchester Children's University Hospitals NHS Trust
No information available
Trust (UK) NHS R&D Support Funding
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 | 01/06/2007 | Yes | No |
