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ISRCTN
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ISRCTN42557578
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial to compare all aspects of laparoscopic hernia repair with conventional open technique
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Scientific title
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Acronym
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N/A
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Serial number at source
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REC00024
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Study hypothesis
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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 per 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.
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Lay summary
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Not provided at time of registration
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Digestive system diseases
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Participants - inclusion criteria
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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.
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Participants - exclusion criteria
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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
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Anticipated start date
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01/04/1995
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Anticipated end date
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01/08/1999
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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Not provided at time of registration
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Interventions
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Extra-peritoneal laparoscopic hernia repair vs open 'Lichtenstein' repair.
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Primary outcome measure(s)
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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 three 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 one and two 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.
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Secondary outcome measure(s)
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POSTOPERATIVE 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.
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Sources of funding
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NHS Executive London (UK)
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Trial website
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Publications
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Contact name
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Mr
R
Taylor
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Address
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St George's Healthcare NHS Trust
St George's Hospital
Blackshaw Road
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City/town
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London
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Zip/Postcode
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SW17 0QT
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Country
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United Kingdom
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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25/07/2011
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Date ISRCTN assigned
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23/01/2004
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