Post-Laparoscopic Cholecystectomy Pain: Benefit of Intraperitoneal Saline
| ISRCTN | ISRCTN63839707 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN63839707 |
| Secondary identifying numbers | N0533152392 |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 09/09/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Signs and Symptoms
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 Daniel Thomas
Scientific
Scientific
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
| Phone | +44 20 8302 2678 |
|---|---|
| daniel.thomas@qms.nhs.uk |
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Not Specified |
| Scientific title | Post-Laparoscopic Cholecystectomy Pain: Benefit of Intraperitoneal Saline |
| Study objectives | Study aims: 1. To assess a simple way of pain reduction post-operatively 2. To evaluate if this intervention influences the timing of patient discharge and the rate of day case Laparoscopic Cholecystectomy 3. To examine individual differences and identify patient characteristics that may predict likely success and failure from this intervention |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Signs and Symptoms: Post operative pain |
| Intervention | 1. Normal saline instilled intraperitoneally at end of operation 2. Control |
| Intervention type | Other |
| Primary outcome measure | 1. Pain Score 2. Nausea 3. Vomiting 4. Duration of hospitalisation 5. Re-admission within 10 days |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/10/2004 |
| Completion date | 30/09/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 80 |
| Key inclusion criteria | 80 patients at Queen Mary's |
| Key exclusion criteria | 1. Any procedure which had to be converted to laparotomy 2. Any patient where the operating surgeon did not adhere to the study protocol 3. Any patient whose cognitive function does not allow them to understand consent to this study |
| Date of first enrolment | 01/10/2004 |
| Date of final enrolment | 30/09/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
DA14 6LT
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
Queen Mary's Sidcup NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
09/09/2016: No publications found in PubMed, verifying study status with principal investigator.
