Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
REC00024
Study information
Scientific title
Acronym
Study hypothesis
The aim of the proposed study is to compare, in a prospective RCT, the extra-peritoneal laparoscopic hernia repair with the open 'Lichtenstein' repair.
Primary assessments and comparisons will be made concerning:
1. Incidence of pre- and post-operative complications
2. Time to return to normal activities/work/sport
Secondary assessments and comparisons will be made concerning:
1. Severity and duration of post-operative pain
2. Duration of operation
3. Overall patient satisfaction
4. Cost effectiveness
In addition, the feasibility of increasing the proportion of patients with inguinal hernia who can be operated on as day cases will be evaluated.
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
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Digestive system diseases
Intervention
Extra-peritoneal laparoscopic hernia repair vs open 'Lichtenstein' repair.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Post-operative complications: patients will be seen 1 and 2 weeks after surgery and then yearly thereafter. Wounds will be reviewed by an independent observer on each occasion the patients are seen. Classification will be into two groups: 1 = Clean, 2 = Infection with sero-sanguinous or purulent discharge. Suture line erythema will be ignored. Microbiological swabs of any abnormal discharge will be taken for culture. Other complications specific to hernia repairs will also be assessed by an independent observer and will be recorded on standard forms. The independent observer will be the research nurse, or any doctor who is assisting in the out-patient clinic (other than one of the investigators). All patients will be kept under review for at least 3 years.
Time to return to normal activities/work: to avoid the potential problems of a discrepancy between patients' ability to return to work and their motivation, they will be asked to perform a series of straight leg raises in the clinic pre-operatively and at 1 and 2 weeks post-operatively. The tests will involve lifting and returning the leg on the appropriate side to an angle of 45 degrees, with the knee straight, in time to a metronome set at a specified rate. They will be asked to stop when they can no longer keep up with the metronome. This test has been previously validated and will be administered by the research nurse. At each outpatient visit, patients will be assessed as to whether or not their hernia repair limits their daily activities by answering a series of questions related to various common activities of daily living. Working patients will be asked how many days off work were taken post surgery. More specifically, assessments will be made as to whether they could have returned earlier and the reasons for not doing so. Patients not working will be asked how many days after the operation they were able to return to normal activities including sport.
Secondary outcome measures
Post-operative pain: post-operative pain relief will be standardised. Patients will be asked to return any unused tablets with them when they return for their first out-patient visit; the number of returned tablets will be recorded. Patients will also be asked if they have taken any pain relief other than that provided.
Duration of operation: all operative details will be recorded on standard forms. Duration of operation represents the time from first incision to insertion of last stitch.
Cost effectiveness: equipment used, whether days off work (either patient or partner) resulted in personal financial loss and cost to the community in days lost will be measured. More detailed costing studies will be carried out for a sample group.
Patient satisfaction: patients will be required at every post-operative visit to rate their overall satisfaction with the operation.
Overall trial start date
01/04/1995
Overall trial end date
01/08/1999
Reason abandoned
Eligibility
Participant inclusion criteria
Patients over the age of 20 years who have a simple inguinal hernia, bilateral inguinal hernia or a recurrent hernia. The patients will be counselled in detail regarding all aspects of both laparoscopic and Lichtenstein repair.
Participant type
Patient
Age group
Adult
Gender
Not Specified
Target number of participants
Not provided at time of registration
Participant exclusion criteria
1. Irreducible, partly reducible or strangulated hernia
2. Previous major lower abdominal incisions (appendicectomy acceptable)
3. Unfit for a general anesthetic
4. Giant scrotal hernia
5. Pregnancy
Recruitment start date
01/04/1995
Recruitment end date
01/08/1999
Locations
Countries of recruitment
United Kingdom
Trial participating centre
St George's Healthcare NHS Trust
London
SW17 0QT
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 London (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