Prospective randomised trial to evaluate laparoscopic versus open bilayer patch herniorrhaphy for the treatment of primary unilateral inguinal hernia

ISRCTN ISRCTN00532630
DOI https://doi.org/10.1186/ISRCTN00532630
Secondary identifying numbers N0084125082
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
01/05/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Urological and Genital Diseases
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

Mr Colm O'Boyle
Scientific

Department of Surgery
Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleProspective randomised trial to evaluate laparoscopic versus open bilayer patch herniorrhaphy for the treatment of primary unilateral inguinal hernia
Study objectivesTo evaluate laparoscopic herniorrhaphy under general anaesthetic compared to open patch herniorrhaphy under local anaesthetic in the treatment of primary inguinal hernia.
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedUrological and Genital Diseases: Inguinal hernia
InterventionLaparoscopic herniorrhaphy under general anaesthetic compared to open patch herniorrhaphy under local anaesthetic in the treatment of primary inguinal hernia.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date29/05/2003
Completion date01/06/2005

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants398 patients will be enrolled
Key inclusion criteriaNot provided at time of registration
Key exclusion criteriaNot provided at time of registration
Date of first enrolment29/05/2003
Date of final enrolment01/06/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Hull Royal Infirmary
Hull
HU3 2JZ
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

The North and South Bank Research and Development Consortium (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