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 |
| Protocol serial number | N0453168841 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | Central Manchester and Manchester Children's University Hospitals NHS Trust (UK) - Trust Endowment,, NHS R&D Support Funding |
- 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
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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised comparative study |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | CO2 |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| Key inclusion criteria | Consenting adult patients aged 16-80 years |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 19/07/2005 |
| Date of final enrolment | 30/12/2005 |
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 |
