Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
30/04/2010
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.dh.gov.uk/Home/fs/en

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

  1. 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.

Additional files

Editorial Notes