Randomised controlled trial of laparoscopic versus open repair of inguinal hernia

ISRCTN ISRCTN64721841
DOI https://doi.org/10.1186/ISRCTN64721841
Secondary identifying numbers N/A
Submission date
23/01/2004
Registration date
23/01/2004
Last edited
16/04/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Digestive System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Douglas McWhinnie
Scientific

Milton Keynes General Hospital Trust
Milton Keynes
M6 5AZ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study objectivesAdded as of 22/05/2008:
To establish the safety, short term outcome, and theatre costs of transabdominal laparoscopic repair of inguinal hernia performed as day surgery.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedInguinal hernia
InterventionLaparoscopic or open repair of inguinal hernia
Intervention typeOther
Primary outcome measureAdded 16/04/2009:
1. Morbidity
2. Post-operative pain and use of analgesics
3. Quality of life
4. Theatre costs

Outcome was assessed by questionnaires administered to patients daily for 10 days and at six weeks post-operatively and by outpatient review at six weeks.
Secondary outcome measuresNo secondary outcome measures
Overall study start date01/12/1992
Completion date30/06/1994

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants125
Key inclusion criteria1. Primary, unilateral inguinal hernia
2. Aged less than 70 years
Key exclusion criteriaPrevious major abdominal surgery
Date of first enrolment01/12/1992
Date of final enrolment30/06/1994

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Milton Keynes General Hospital Trust
Milton Keynes
M6 5AZ
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive South East (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 14/10/1995 Yes No