Condition category
Digestive System
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
22/04/2015
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 Paul Edwards

ORCID ID

Contact details

Countess of Chester NHS Trust
Liverpool Road
Chester
CH3 1UL
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0072101043

Study information

Scientific title

The timings of cholecystectomy in acute pancreatitis: a randomised controlled trial

Acronym

Study hypothesis

1. Does a cholecystectomy within 2 weeks of an attack of acute pancreatitis prevent recurrent pancreatitis events?
2. Does a cholecystectomy within 2 weeks compared with delayed surgery (6 weeks) affect complications and hospital stay duration?

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

Condition

Pancreatitis

Intervention

Patients with acute gallstone pancreatitis will be randomised to undergo early (2 weeks) or late (6 weeks) cholecystectomy.

Intervention type

Procedure/Surgery

Phase

Drug names

Primary outcome measures

1. Risk of recurrent pancreatitis in delayed surgery groups
2. Operative complication rate
3. Local complications in delayed surgery group such as pseudocyst
4. Total length of time in hospital - mortality rates

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/04/2001

Overall trial end date

01/04/2003

Reason abandoned

Eligibility

Participant inclusion criteria

All patients admitted with acute pancreatitis secondary to gallstones will be admitted into study.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Approximately 100 participants

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/04/2001

Recruitment end date

01/04/2003

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Countess of Chester NHS Trust
Chester
CH3 1UL
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Countess of Chester Hospital 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