Condition category
Signs and Symptoms
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
09/09/2016
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 Daniel Thomas

ORCID ID

Contact details

Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom
+44 20 8302 2678
daniel.thomas@qms.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0533152392

Study information

Scientific title

Post-Laparoscopic Cholecystectomy Pain: Benefit of Intraperitoneal Saline

Acronym

Study hypothesis

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

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

Signs and Symptoms: Post operative pain

Intervention

1. Normal saline instilled intraperitoneally at end of operation
2. Control

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/10/2004

Overall trial end date

30/09/2005

Reason abandoned

Eligibility

Participant inclusion criteria

80 patients at Queen Mary's

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

80

Participant 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

Recruitment start date

01/10/2004

Recruitment end date

30/09/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Queen Mary's Sidcup NHS Trust
Sidcup
DA14 6LT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Queen Mary's Sidcup NHS Trust (UK)

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

09/09/2016: No publications found in PubMed, verifying study status with principal investigator.