A comparison of endoscopic and radiological methods of placement of large bore gastrostomy tubes

ISRCTN ISRCTN44313851
DOI https://doi.org/10.1186/ISRCTN44313851
Secondary identifying numbers N0226118476
Submission date
12/09/2003
Registration date
12/09/2003
Last edited
11/02/2010
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Surgery
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

Dr Derrick F Martin
Scientific

Main X Ray Area A
South Manchester University Hospitals NHS Trust
Wythenshawe Hospital
Southmoor Road
Manchester
M23 9LT
United Kingdom

Phone +44 (0)161 291 6237
Email derrick.martin@smuht.nwest.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeOther
Scientific title
Study objectivesTo compare the success and complication rates of the modified and the endoscopic method in a prospective randomised study.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedGastrostomy tube insertion
InterventionTo compare the success and complication rates of the modified and the endoscopic method.
Intervention typeProcedure/Surgery
Primary outcome measureSuccessful insertion of gastrostomy tube at the first attempt.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/12/2002
Completion date01/12/2004
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants200
Key inclusion criteria200 Consecutive patients undergoing percutaneous gastrostomy (100 each arm).
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/12/2002
Date of final enrolment01/12/2004

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Main X Ray Area A
Manchester
M23 9LT
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

South Manchester 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