Condition category
Digestive System
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
08/09/2009
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 D N Lobo

ORCID ID

Contact details

Division of GI Surgery
E Floor West Block
Queens Medical Centre
Nottingham
NG7 2UH
United Kingdom
+44 (0)115 970 9245
dileep.lobo@nottingham.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0192151057

Study information

Scientific title

A randomised controlled trial of early laparoscopic cholecystectomy versus conventional management for newly diagnosed gallbladder disease: a cost minimisation and outcome study

Acronym

Study hypothesis

Comparing the direct hospital-based and the societal costs of early and conventional management for newly diagnosed gallbladder disease.

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

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Gallbladder diseases

Intervention

1. Laparoscopic cholecystectomy
2. Analgesia intravenous fluids and antibiotics

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

To see whether early management has a bearing on gallstone related morbidity and mortality.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2004

Overall trial end date

28/02/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Male and females
2. Aged 18 - 80 years
3. Residing in Nottingham area
4. Presenting with primary diagnosis of bilary colic or acute cholecystitis

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

138 (69 each in the early and conventional groups)

Participant exclusion criteria

1. Patients diagnosed with acute severe gallstone pancreatis or gallstone-related ascending cholangitis (Jaundice temperature greater than 39°C and rigors)
2. Patients less than 18 or more than 80 years
3. Patients who have medical co-morbidity preventing either laparoscopic cholecystectomy or potential inclusion in either treatment arm

Recruitment start date

01/09/2004

Recruitment end date

28/02/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Division of GI Surgery
Nottingham
NG7 2UH
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

Queens Medical Centre University Hospital (UK) - 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

2009 cost utility results in http://www.ncbi.nlm.nih.gov/pubmed/19672930

Publication citations

  1. Cost utility results

    Macafee DA, Humes DJ, Bouliotis G, Beckingham IJ, Whynes DK, Lobo DN, Prospective randomized trial using cost-utility analysis of early versus delayed laparoscopic cholecystectomy for acute gallbladder disease., Br J Surg, 2009, 96, 9, 1031-1040, doi: 10.1002/bjs.6685.

Additional files

Editorial Notes