Contact information
Type
Scientific
Primary contact
Mr Basil Ammori
ORCID ID
Contact details
MRI Central Manchester & Manchester Children's University Hospitals
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom
+44 (0)161 276 3510
basil.ammori@cmmc.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0453168843
Study information
Scientific title
Acronym
Study hypothesis
To compare cutting and conical mechanisms for port induction with regard to port fixity to the abdominal wall during laparoscopic surgery.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/05/2003
Overall trial end date
01/05/2005
Reason abandoned
Eligibility
Participant inclusion criteria
50 patients will be consented and the study will compare 50 5mm ports and 50 10mm ports in each group.
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/05/2003
Recruitment end date
01/05/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
MRI Central Manchester & Manchester Children's University Hospitals
Manchester
M13 9WL
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
Central Manchester and Manchester Children's University Hospitals NHS Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Trust (UK) NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2007 results in http://www.ncbi.nlm.nih.gov/pubmed/17287914
Publication citations
-
Results
Hamade AM, Issa ME, Haylett KR, Ammori BJ, Fixity of ports to the abdominal wall during laparoscopic surgery: a randomized comparison of cutting versus blunt trocars., Surg Endosc, 2007, 21, 6, 965-969, doi: 10.1007/s00464-006-9142-3.