Condition category
Digestive System
Date applied
23/01/2004
Date assigned
23/01/2004
Last edited
16/04/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Douglas McWhinnie

ORCID ID

Contact details

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

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

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

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

Condition

Inguinal hernia

Intervention

Laparoscopic or open repair of inguinal hernia

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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.

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/12/1992

Overall trial end date

30/06/1994

Reason abandoned

Eligibility

Participant inclusion criteria

1. Primary, unilateral inguinal hernia
2. Aged less than 70 years

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

125

Participant exclusion criteria

Previous major abdominal surgery

Recruitment start date

01/12/1992

Recruitment end date

30/06/1994

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Milton Keynes General Hospital Trust
Milton Keynes
M6 5AZ
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

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

NHS Executive South East (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

Results in http://www.ncbi.nlm.nih.gov/pubmed/7580639

Publication citations

  1. Results

    Lawrence K, McWhinnie D, Goodwin A, Doll H, Gordon A, Gray A, Britton J, Collin J, Randomised controlled trial of laparoscopic versus open repair of inguinal hernia: early results., BMJ, 1995, 311, 7011, 981-985.

Additional files

Editorial Notes