Randomised controlled trial of laparoscopic versus open repair of inguinal hernia

ISRCTN	ISRCTN64721841
DOI	https://doi.org/10.1186/ISRCTN64721841
Protocol serial number	N/A
Sponsor	NHS R&D Regional Programme Register - Department of Health (UK)
Funder	NHS Executive South East (UK)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Mr Douglas McWhinnie
Scientific

Milton Keynes General Hospital Trust
Milton Keynes
M6 5AZ
United Kingdom

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Inguinal hernia
Intervention	Laparoscopic or open repair of inguinal hernia
Intervention type	Other
Primary outcome measure(s)	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.
Key secondary outcome measure(s)	No secondary outcome measures
Completion date	30/06/1994

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	125
Key inclusion criteria	1. Primary, unilateral inguinal hernia 2. Aged less than 70 years
Key exclusion criteria	Previous major abdominal surgery
Date of first enrolment	01/12/1992
Date of final enrolment	30/06/1994

Milton Keynes General Hospital Trust

Milton Keynes
M6 5AZ
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	Results	14/10/1995		Yes	No