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 |
| Protocol serial number | N0453168843 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Central Manchester and Manchester Children's University Hospitals NHS Trust, Trust (UK) NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
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. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/05/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| 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
- United Kingdom
- England
Study participating centre
MRI Central Manchester & Manchester Children's University Hospitals
Manchester
M13 9WL
United Kingdom
M13 9WL
United Kingdom
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 | 01/06/2007 | Yes | No |
