Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
Acronym
Study hypothesis
Added 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
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
Inguinal hernia
Intervention
Laparoscopic or open repair of inguinal hernia
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Added 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 measures
No secondary outcome measures
Overall trial start date
01/12/1992
Overall trial end date
30/06/1994
Reason abandoned
Eligibility
Participant inclusion criteria
1. Primary, unilateral inguinal hernia
2. Aged less than 70 years
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
125
Participant exclusion criteria
Previous major abdominal surgery
Recruitment start date
01/12/1992
Recruitment end date
30/06/1994
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Milton Keynes General Hospital Trust
Milton Keynes
M6 5AZ
United Kingdom
Sponsor information
Organisation
NHS R&D Regional Programme Register - Department of Health (UK)
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Government
Funder name
NHS Executive South East (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
Results in http://www.ncbi.nlm.nih.gov/pubmed/7580639
Publication citations
-
Results
Lawrence K, McWhinnie D, Goodwin A, Doll H, Gordon A, Gray A, Britton J, Collin J, Randomised controlled trial of laparoscopic versus open repair of inguinal hernia: early results., BMJ, 1995, 311, 7011, 981-985.