Digestive system diseases Digestive System Hernia repair
Conditions
Interventions
Extra-peritoneal laparoscopic hernia repair vs open 'Lichtenstein' repair.
Sponsors
NHS R&D Regional Programme Register - Department of Health (UK)
Eligibility
Inclusion criteria
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.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United Kingdom
Outcome results
None listed