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.: PACTR202010795072235 Date of Approval: 19/10/2020
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Treatment of strongulated inguinal hernia : Bassini versus Lichtenstein, "HIERP" trial
Official scientific title Treatment of strongulated inguinal hernia : Bassini versus Lichtenstein, randomized control trial "HIERP"
Brief summary describing the background and objectives of the trial A randomized trial to compare two groups with strangulated inguinal hernia, the first group is treated with Bassini technique and Lichtenstein for the second group( non tension technique) The main objectif is to compare post operative infection, secondary objectives are post operative pain, recurrence and other specific complications.
Type of trial RCT
Acronym (If the trial has an acronym then please provide)
Disease(s) or condition(s) being studied Surgery
Sub-Disease(s) or condition(s) being studied
Purpose of the trial Treatment: Surgery
Anticipated trial start date 01/07/2017
Actual trial start date 01/07/2017
Anticipated date of last follow up 31/12/2020
Actual Last follow-up date
Anticipated target sample size (number of participants) 78
Actual target sample size (number of participants)
Recruitment status Recruiting
Publication URL
Secondary Ids Issuing authority/Trial register
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
Factorial: participants randomly allocated to either no, one, some or all interventions simultaneously Randomised Simple randomization using a randomization table from a statistics book Allocation was determined by the holder of the sequence who is situated off site Open-label(Masking Not Used)
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Experimental Group Lichtenstein 42 months This group is treated with a polypropylen mech like described on Lichtenstein technique 39
Control Group Bassini 42months This group is treated with simple raffia like described on Bassini technique. 39 Active-Treatment of Control Group
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
age over 18 years ASA score1 or 2 informed consent  ASA score 3 and 4  Pre or per operative peritonitis  Intestinal resection  Intra peritoneal mass  Ascites  Other associated hernias 80 and over: 80+ Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 29 Year(s) 92 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 07/01/2017 comite de protection des personnes du Sud
Ethics Committee Address
Street address City Postal code Country
Majida Boulila km 0.5 Sfax 3029 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Secondary Outcome scrotal hematoma 30 days
Primary Outcome post operative infection 30 days
Secondary Outcome post operative pain 30 days
Secondary Outcome recurrence 6 months
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
Habib Bourguiba universal hospital Rue Al Firdaws SFAX 3029 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Habib Bourguiba universal hospital Road Elferdaws sfax 3029 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Habib Bourguiba universal hospital Elferdaws Sfax 3029 Tunisia Hospital
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Haitham Rejab rejabhaitham@yahoo.fr +21658127631 Majida Boulila
City Postal code Country Position/Affiliation
sfax 3000 Tunisia surgeon
Role Name Email Phone Street address
Public Enquiries Zied Hadrich hadrich1988@gmail.com +21654420839 teniour street km 8
City Postal code Country Position/Affiliation
sfax 3041 Tunisia surgeon
Role Name Email Phone Street address
Scientific Enquiries Jihene Trabelsi hadrichzizou@hotmail.com +21651061561 Majida Boulila
City Postal code Country Position/Affiliation
Sfax 3029 Tunisia preventive medecine
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Individual participant data that underlie the results reported in this article, after deidentification (text, tables, figures, and appendices) Informed Consent Form,Statistical Analysis Plan,Study Protocol Immediately following publication, No end date Researchers who provide a methodologically sound proposal
URL Results Available Results Summary Result Posting Date First Journal Publication Date
No
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