Condition category
Surgery
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
24/09/2013
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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0453168841

Study information

Scientific title

Acronym

Study hypothesis

This 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

Not provided at time of registration

Study design

Randomised comparative study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Surgery: Laparoscopy

Intervention

The 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 type

Drug

Phase

Not Specified

Drug names

CO2

Primary outcome measures

Not provided at time of registration

Secondary outcome measures

Not provided at time of registration

Overall trial start date

19/07/2005

Overall trial end date

30/12/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Consenting adult patients aged 16-80 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

19/07/2005

Recruitment end date

30/12/2005

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 (UK) - Trust Endowment,

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

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

Publication citations

Additional files

Editorial Notes