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.: PACTR201909553182490 Date of Approval: 25/09/2019
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Transinguinal mesh repair of inguinal hernias: Lichtenstein technique vs Onstep technique
Official scientific title Transinguinal mesh repair of inguinal hernias: Lichtenstein technique vs Onstep technique
Brief summary describing the background and objectives of the trial Tension-free mesh inguinal hernia repairs have reduced considerably the recurrence rate by eliminating the tension induced by herniorrhaphies. Although the Lichtenstein technique introduced in 1986 remains the gold standard in hernia repair, chronic postoperative pain affecting daily activity and impairing sexual function remain the main complication of this procedure. The ONSTEP (Open New Simplified Totally Extra-Peritoneal) technique is a newer hybrid method based on a memory-ring prosthesis placed in the preperitoneal and premuscular space. Because of the simplicity of the procedure and the lack of fixation of the prosthesis, this technique seems to be associated with less chronic postoperative pain. The aim of this study was to compare the Lichtenstein technique versus the ONSTEP technique mainly in relation to chronic postoperative pain.
Type of trial CCT
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 01/11/2016
Actual trial start date 01/11/2016
Anticipated date of last follow up 20/09/2019
Actual Last follow-up date
Anticipated target sample size (number of participants) 100
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
Parallel: different groups receive different interventions at same time during study Non-randomised Masking/blinding used Outcome Assessors,Participants
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Lichtenstein technique Less than 60 minutes The intervention is performed as described by Amid 50 Active-Treatment of Control Group
Experimental Group Onstep technique Less than 60 minutes The intervention is performed as described by Lourenço 50
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
- Patients ≥ 18 years - Primary inguinal hernias - Incarcerated or irreducible hernia - Other abdominal hernias being operated at the same time or such surgery was planned for the follow-up period - Emergency procedures - ASA score > 3 - BMI > 40 kg/m2 or BMI < 18 kg/m2 - Failure to give consent for participation - Chronic alcoholism - Local (site of surgery) or systemic infection - Previous surgery that impaired the sensation in the groin area and/or the sexual function - Known disease that impairs central or peripheral nerve function - Concurrent malignant disease - Mental disorder that requires medication - Impairment of cognitive function - Chronic pain that requires daily medication 80 and over: 80+ Year,Adolescent: 13 Year-18 Year,Adult: 19 Year-44 Year,Aged: 65+ Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 100 Year(s) Male
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 13/06/2019 Ethics Committee of the faculty of Medecine of Oran
Ethics Committee Address
Street address City Postal code Country
BP 1510 El Menaouer 31000 Oran 31000 Algeria
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Chronic pain 6 months
Secondary Outcome Cost At the patient discharge
Secondary Outcome Impairment of the sexual function in relation with pain 6 months
Secondary Outcome Alteration of daily activity 6 months
Secondary Outcome The aesthetic satisfaction 6 months
Secondary Outcome Recurrence 6 months
Secondary Outcome Proportion of patients with neuropathic pain 6 months
Secondary Outcome Perioperative complications Perioperative period
Secondary Outcome Early postoperative pain Early postoperative period
Secondary Outcome Operative time At the end of the surgery
Secondary Outcome Lenght of hospital stay At the patient discharge
Secondary Outcome Time to return to daily activity Follow-up period
Secondary Outcome Time to return to work Follow-up period
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
New Hospital of Bechar Independence Street Bechar 08000 Algeria
FUNDING SOURCES
Name of source Street address City Postal code Country
New Hospital of Bechar Independence Street Bechar 08000 Algeria
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor New Hospital of Bechar Independence Street Bechar 08000 Algeria Hospital
COLLABORATORS
Name Street address City Postal code Country
Mazouzi Slimane Bechar Bechar 08000 Algeria
Brahmi Khadidja Oran Oran 31000 Algeria
Seddiki Mhamed Mohamed Salah Eddine Oran Oran 31000 Algeria
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Toufik Berri t.berri@yahoo.fr 00213552718930 BP 71 Maghnia 13001
City Postal code Country Position/Affiliation
Maghnia 13001 Algeria Assistant Professor in General Surgery
Role Name Email Phone Street address
Scientific Enquiries Toufik Berri t.berri@yahoo.fr 00213552718930 BP 71 Maghnia 13001
City Postal code Country Position/Affiliation
Maghnia 13001 Algeria Assistant Professor in General Surgery
Role Name Email Phone Street address
Public Enquiries Toufik Berri t.berri@yahoo.fr 00213552718930 BP 71 Maghnia 13001
City Postal code Country Position/Affiliation
Maghnia 13001 Algeria Assistant Professor in General surgery
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes Summary results Informed Consent Form Beginning 2 months and ending 5 years following article publication Proposals should be directed to t.berri@yahoo.fr. Researchers who provide a methodologically sound proposal may request access. The data can be used to achieve aims in the approved 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