Pan African Clinical Trials Registry
South African Medical Research Council, South African Cochrane Centre
PO Box 19070, Tygerberg, 7505, South Africa
Telephone: +27 21 938 0506 / +27 21 938 0834 Fax: +27 21 938 0836
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR201311000628947 Date of Registration: 24/08/2013
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Postoperative pain in Lichtenstein with iliohypogastric neurectomy compared to standard Lichtenstein repair in patients with inguinal hernia
Official scientific title Postoperative pain in standard Lichtenstein repair versus Lichtenstein with iliohypogastric neurectomy in patients undergoing inguinal hernia repair
Brief summary describing the background and objectives of the trial Inguinal hernia repair is arguably the commonest general surgical procedure. Greater focus is shifting to short-term quality-of-life of the patient, using postoperative pain as an indicator. Iliohypogastric neurectomy has been shown to significantly reduce postoperative pain. A study to compare the short-term and medium-term postoperative pain scores of Lichtenstein hernia repair, with and without iliohypogastric neurectomy, was conducted in a tertiary hospital in Uganda, a low income country.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Inguinal hernia,Musculoskeletal Diseases,Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 02/07/2012
Actual trial start date 09/07/2012
Anticipated date of last follow up 08/02/2013
Actual Last follow-up date 22/02/2013
Anticipated target sample size (number of participants) 86
Actual target sample size (number of participants) 96
Recruitment status Completed
Publication URL
Secondary Ids Issuing authority/Trial register
2012 - 148 Makerere University School of Medicine Research and Ethics Committee, Makerere University, Uganda
STUDY DESIGN
Intervention assignment Allocation to intervention If randomised, describe how the allocation sequence was generated Describe how the allocation sequence/code was concealed from the person allocating the participants to the intervention arms Masking If masking / blinding was used
Parallel: different groups receive different interventions at same time during study Randomised Permuted block randomisation with block sizes of 4 to 6 Sealed opaque envelopes Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lichtenstein repair Lichtenstein repair 46 Active-Treatment of Control Group
Experimental Group Lichtenstein repair with iliohypogastric neurectomy Lichtenstein repair with iliohypogastric neurectomy 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
-Primary inguinal hernia -18 years and above -Written informed consent -American Society of Anaesthesiologists (ASA) score I or II -Accessible telephone contact -Residence less than 1 hour travel time or a distance not > 20 km from study site -Availability of a responsible accompanying attendant -Known bleeding disorders 18 Year(s) 72 Year(s) Both
ETHICS APPROVAL
Has the study received appropriate ethics committee approval Date the study will be submitted for approval Date of approval Name of the ethics committee
Yes 18/06/2012 Makerere University School of Medicine Research and Ethics Committee
Ethics Committee Address
Street address City Postal code Country
Mulago Hill Road Kampala P O B0x 7072 Uganda
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain score using the Visual Analogue Scale -2 hours postoperative
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Mulago National Referral and Teaching HospitalHospita Mulago Hill Road kampala P O Box 7051 Uganda
FUNDING SOURCES
Name of source Street address City Postal code Country
Authors Mulago Hill Road kampala P O Box 7072 Uganda
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Department of Surgery Mulago Hill Road kampala P O Box 7072 Uganda University
COLLABORATORS
Name Street address City Postal code Country
Francis Basimbe Mulago Hill Road kampala P O Box 7072 Uganda
Peter A. Ongom Mulago Hill Road kampala P O Box 7072 Uganda
Stepphen C. Kijjambu Mulago Hill Road kampala P O Box 7072 Uganda
Olivia kituuka Mulago Hill Road kampala P O Box 7072 Uganda
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Francis Basimbe basimbef@yahoo.co.uk +256 782 506 721 Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala P O Box 7072 Uganda General Surgeon
Role Name Email Phone Street address
Public Enquiries Peter Ongom petongom@yahoo.co.uk +256 772 454 936 Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala P O Box 7072 Uganda Lecturer and General Surgeon
Role Name Email Phone Street address
Scientific Enquiries Peter Ongom petongom@yahoo.co.uk +256 772 454 936 Mulago Hill Road
City Postal code Country Position/Affiliation
Kampala P O Box 7072 Uganda General Surgeon
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information