Low rate versus high rate insufflation of the peritoneal cavity for laparoscopic surgery: a randomised comparative study

ISRCTN ISRCTN44566783
DOI https://doi.org/10.1186/ISRCTN44566783
Secondary identifying numbers N0453168841
Submission date
29/09/2006
Registration date
29/09/2006
Last edited
24/09/2013
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Basil Ammori
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

Study information

Study designRandomised comparative study
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesThis study aims to find out whether the low rate and high rate of CO2 insufflation at the commencement of laparoscopic surgery have different effects on cardiac function.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedSurgery: Laparoscopy
InterventionThe study involves insufflating the abdomen with gas at either a low rate or high rate and evaluating its impact on the efficacy of the heart pump and on the hormones released during surgery. It will be a randomised clinical study involving 2 groups (CO2 insufflation at 1 l/1min & CO2 insufflation of 18 l/min)
Intervention typeDrug
Pharmaceutical study type(s)
PhaseNot Specified
Drug / device / biological / vaccine name(s)CO2
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date19/07/2005
Completion date30/12/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaConsenting adult patients aged 16-80 years
Key exclusion criteriaNot provided at time of registration
Date of first enrolment19/07/2005
Date of final enrolment30/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRI Central Manchester & Manchester Children's University Hospitals
Manchester
M13 9WL
United Kingdom

Sponsor information

Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email 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 (UK) - Trust Endowment,

No information available

NHS R&D Support Funding

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan