Should we remove a normal-looking appendix at a diagnostic laparoscopy in patients with acute right iliac fossa pain and no other detectable pathology?

ISRCTN ISRCTN06195808
DOI https://doi.org/10.1186/ISRCTN06195808
Secondary identifying numbers N0453122643
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
15/05/2012
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Surgery
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Basil Ammori
Scientific

Central Manchester & Manchester Children's University Hospitals MRI
Manchester Royal Infirmary
Oxford Road
Manchester
M13 9WL
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedAppendectomy
InterventionRandomised controlled trial comparing laprascopic removal of normal looking appendix with non-removal on diagnosis of appendicitis.
Intervention typeProcedure/Surgery
Primary outcome measureNumber of patients readmitted with right lower abdominal pain during a follow up period of 12 months.
Secondary outcome measuresNot provided at time of registration
Overall study start date06/01/2003
Completion date31/12/2004

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexBoth
Target number of participantsNot provided at time of registration
Key inclusion criteriaAdult subjects aged >18 years who present and are admitted to hospital acutely with right lower abdominal pain and are suspected to have acute appendicitis for which a diagnostic laparoscopy is contemplated will be considered for the study, and consented. Patients who were consented and in whom no detectable pathology is found at the time of diagnostic laparoscopy will be randomised in theatre.
Key exclusion criteriaDoes not match inclusion criteria
Date of first enrolment06/01/2003
Date of final enrolment31/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Central Manchester & Manchester Children's University Hospitals MRI
Manchester
M13 9WL
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Hospital/treatment centre

Central Manchester and Manchester Children's University Hospitals NHS Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/10/2009 Yes No