Randomised controlled trial to compare all aspects of laparoscopic hernia repair with conventional open technique

ISRCTN	ISRCTN42557578
DOI	https://doi.org/10.1186/ISRCTN42557578
Secondary identifying numbers	REC00024

Submission date: 23/01/2004
Registration date: 23/01/2004
Last edited: 06/12/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Digestive System

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 R Taylor
Scientific

St George's Healthcare NHS Trust
St George's Hospital
Blackshaw Road
London
SW17 0QT
United Kingdom

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Randomised controlled trial to compare all aspects of laparoscopic hernia repair with conventional open technique
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Digestive system diseases
Intervention	Extra-peritoneal laparoscopic hernia repair vs open 'Lichtenstein' repair.
Intervention type	Other
Primary outcome measure	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 study start date	01/04/1995
Completion date	01/08/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key 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.
Key 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
Date of first enrolment	01/04/1995
Date of final enrolment	01/08/1999

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

St George's Healthcare NHS Trust

London
SW17 0QT
United Kingdom

Sponsor information

NHS R&D Regional Programme Register - Department of Health (UK)
Government

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Phone	+44 (0)20 7307 2622
Email	dhmail@doh.gsi.org.uk
Website	http://www.doh.gov.uk

Funders

Funder type

Government

NHS Executive London (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

06/12/2019: No publications found. All search options exhausted.