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 0835 or +27 21 938 0967
Email: pactradmin@mrc.ac.za Website: pactr.samrc.ac.za
Trial no.: PACTR202607652566425 Date of Registration: 27/07/2026
Trial Status: Retrospective registration - This trial was registered after enrolment of the first participant
TRIAL DESCRIPTION
Public title Comparison of Polypropylene Mesh and Self-Gripping ProGrip® Mesh for Open Repair of Primary Inguinal Hernia
Official scientific title Polypropylene Mesh Versus Self-Gripping ProGrip® Mesh in Lichtenstein Repair of Primary Unilateral Inguinal Hernia: A Prospective Double-Blind Randomized Controlled Trial
Brief summary describing the background and objectives of the trial Inguinal hernia repair is one of the most frequently performed procedures in general surgery. The Lichtenstein tension-free technique using polypropylene mesh remains the standard approach for open inguinal hernia repair. Self-gripping meshes such as ProGrip® have been developed to eliminate the need for suture fixation, potentially reducing operative time and postoperative pain. However, evidence regarding their clinical benefits and cost-effectiveness remains inconclusive. This prospective, single-center, double-blind, randomized controlled trial aimed to compare polypropylene mesh and self-gripping ProGrip® mesh in patients undergoing elective repair of primary unilateral uncomplicated inguinal hernia. The primary objectives were to compare postoperative pain between the two groups. Secondary objectives included comparison of operative time, procedure cost, postoperative complications, and hernia recurrence.
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 01/11/2021
Actual trial start date 01/11/2021
Anticipated date of last follow up 30/11/2023
Actual Last follow-up date 30/11/2023
Anticipated target sample size (number of participants) 56
Actual target sample size (number of participants) 56
Recruitment status Completed
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 Randomised Simple randomization using a randomization table created by a computer software program Sealed opaque envelopes Masking/blinding used Care giver/Provider
INTERVENTIONS
Intervention type Intervention name Dose Duration Intervention description Group size Nature of control
Control Group Inguinal hernia repair Lichtenstein Single surgical procedure performed during one operative session. Participants underwent elective open Lichtenstein repair of a primary unilateral uncomplicated inguinal hernia using a standard lightweight polypropylene mesh fixed with non-absorbable sutures according to the standard Lichtenstein technique. 28 Active-Treatment of Control Group
Experimental Group Self Gripping Mesh Single surgical procedure performed during one operative session. Participants underwent elective open Lichtenstein repair of a primary unilateral uncomplicated inguinal hernia using a self-gripping ProGrip® mesh (Medtronic), implanted without suture fixation according to the manufacturer’s recommendations. 28
ELIGIBILITY CRITERIA
List inclusion criteria List exclusion criteria Age Category Minimum age Maximum age Gender
Male patients aged 20 to 85 years. Primary unilateral inguinal hernia. Elective repair of an uncomplicated, non-recurrent inguinal hernia. Eligible for spinal anesthesia. Provided written informed consent. Bilateral inguinal hernia. Femoral hernia. Complicated inguinal hernia (incarcerated or strangulated). Recurrent inguinal hernia. Absolute contraindication to prosthetic mesh implantation (e.g., acute infection or systemic disease associated with a high risk of mesh infection). Contraindication to spinal anesthesia. 80 and over: 80+ Year,Adult: 18 Year(s)-44 Year(s),Aged: 65 Year(s)-79 Year(s),Middle Aged: 45 Year(s)-64 Year(s) 18 Year(s) 85 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 12/07/2021 La Rabta Hospital Ethics Comitee
Ethics Committee Address
Street address City Postal code Country
Rue jbal lakhdhar 11 Tunis 1007 Tunisia
OUTCOMES
Type of outcome Outcome Timepoint(s) at which outcome measured
Primary Outcome Postoperative pain assessed using the Visual Analog Scale (VAS), including both acute and chronic postoperative pain. Postoperative day 1, postoperative day 7, postoperative month 1
Secondary Outcome Operative time (minutes), defined as the time elapsed between receipt of the mesh by the operating surgeon and completion of skin closure. During surgery.
Secondary Outcome Cost of the surgical procedure, including the cost of the mesh and fixation materials. At the time of surgery.
Secondary Outcome Hernia recurrence confirmed by clinical examination. During the 12-month follow-up.
Secondary Outcome Postoperative complications, including seroma, parietal hematoma, scrotal hematoma, surgical site infection, mesh infection During the 12-month follow-up.
Secondary Outcome Health-related quality of life assessed using the validated Tunisian Arabic version of the 36-Item Short Form Health Survey (SF-36). at postoperative month 3, 6 and 12
RECRUITMENT CENTRES
Name of recruitment centre Street address City Postal code Country
La Rabta Hospital Rue jbal lakhdhar Tunis 1007 Tunisia
FUNDING SOURCES
Name of source Street address City Postal code Country
Faculte de Medecine de Tunis 15 Rue jbal lakhdhar Tunis 1007 Tunisia
SPONSORS
Sponsor level Name Street address City Postal code Country Nature of sponsor
Primary Sponsor Faculte de Medecine de Tunis 15 Rue Jbal Lakhdhar tunis 1007 Tunisia University
COLLABORATORS
Name Street address City Postal code Country
CONTACT PEOPLE
Role Name Email Phone Street address
Principal Investigator Souhaib Atri souhaib.atri@gmail.com +21621697149 Rue Fawz
City Postal code Country Position/Affiliation
Rawed 2056 Tunisia Associate Professor at The General Surgery Department La Rabta Hospital
Role Name Email Phone Street address
Public Enquiries Souhaib Atri souhaib.atri@gmail.com +21621697149 Rue Fawz
City Postal code Country Position/Affiliation
Rawed 2056 Tunisia Associate Professor
Role Name Email Phone Street address
Scientific Enquiries Mahdi Hammami mahdihammami174@gmail.com +21694998410 cite Argoub
City Postal code Country Position/Affiliation
Medjez el Bab 9070 Tunisia associate Professor la Rabta Hospital
Role Name Email Phone Street address
Scientific Enquiries Yasmine Hammami yasminehammami9@gmail.com +21699016768 Cite el Manar
City Postal code Country Position/Affiliation
Tunis 2092 Tunisia Surgeon
REPORTING
Share IPD Description Additional Document Types Sharing Time Frame Key Access Criteria
Yes De-identified individual participant data underlying the results reported in this study will be made available upon reasonable request to the corresponding author, following publication of the study Study Protocol Beginning 6 months after publication and ending 5 years after publication. Researchers with a methodologically sound proposal may request access by contacting the corresponding author. Requests will be reviewed by the investigators and the institutional ethics committee.
URL Results Available Results Summary Result Posting Date First Journal Publication Date
Yes 20/07/2026
Result Upload 1: Result Upload 2: Result Upload 3: Result Upload 4: Result Upload 5:
Result - 20/07/2026
Result URL Hyperlinks Link To Protocol
Result URL Hyperlinks
Changes to trial information
Section Name Field Name Date Reason Old Value Updated Value
Eligibility Age group 02/07/2026 age 18 to 85 are included Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s) Adult: 18 Year(s)-44 Year(s), Middle Aged: 45 Year(s)-64 Year(s), Aged: 65 Year(s)-79 Year(s), 80 and over: 80+ Year
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/07/2026 identical names Control Group, Inguinal hernia repair Lichtenstein, , Single surgical procedure performed during one operative session., Participants underwent elective open Lichtenstein repair of a primary unilateral uncomplicated inguinal hernia using a standard lightweight polypropylene mesh fixed with non-absorbable sutures according to the standard Lichtenstein technique., 28, Active-Treatment of Control Group
Section Name Field Name Date Reason Old Value Updated Value
Intervention Intervention List 02/07/2026 identical names Experimental Group, Inguinal hernia repair, , Single surgical procedure performed during one operative session., Participants underwent elective open Lichtenstein repair of a primary unilateral uncomplicated inguinal hernia using a self-gripping ProGrip® mesh (Medtronic), implanted without suture fixation according to the manufacturer’s recommendations., 28, Experimental Group, Self Gripping Mesh, , Single surgical procedure performed during one operative session., Participants underwent elective open Lichtenstein repair of a primary unilateral uncomplicated inguinal hernia using a self-gripping ProGrip® mesh (Medtronic), implanted without suture fixation according to the manufacturer’s recommendations., 28,
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 18/07/2026 time point were added by mistake. we apomogize Primary Outcome, Postoperative pain assessed using the Visual Analog Scale (VAS), including both acute and chronic postoperative pain., Postoperative day 1, postoperative day 7, postoperative month 1, postoperative month 3, postoperative month 6, and postoperative month 12. Primary Outcome, Postoperative pain assessed using the Visual Analog Scale (VAS), including both acute and chronic postoperative pain., Postoperative day 1, postoperative day 7, postoperative month 1
Section Name Field Name Date Reason Old Value Updated Value
Outcome OutCome List 20/07/2026 oversight during first draft Secondary Outcome, Health-related quality of life assessed using the validated Tunisian Arabic version of the 36-Item Short Form Health Survey (SF-36)., at postoperative month 12 Secondary Outcome, Health-related quality of life assessed using the validated Tunisian Arabic version of the 36-Item Short Form Health Survey (SF-36)., at postoperative month 3, 6 and 12
Section Name Field Name Date Reason Old Value Updated Value
Ethics Ethics List 02/07/2026 response to reviewer TRUE, La Rabta Hospital Ethics Comitee, Rue jbal lakhdhar 11, Tunis, 1007, Tunisia, , 12 Jul 2021, +21694998410, ethic.rabta@gmail.com, 42591_38905_4737.pdf TRUE, La Rabta Hospital Ethics Comitee, Rue jbal lakhdhar 11, Tunis, 1007, Tunisia, , 12 Jul 2021, +21694998410, ethic.rabta@gmail.com, 42591_38905_4737.pdf
Section Name Field Name Date Reason Old Value Updated Value
Contact People Contacs List 02/07/2026 A contributor to the study that was not mentioned earlier. Scientific Enquiries, Yasmine, Hammami, Dr., yasminehammami9@gmail.com, , +21699016768, Cite el Manar, Tunis, 2092, Tunisia, Surgeon
Section Name Field Name Date Reason Old Value Updated Value
Reporting Results Available 20/07/2026 results available No Yes
Section Name Field Name Date Reason Old Value Updated Value
Reporting Result Summary Pdf file1 20/07/2026 results available 42591_28740_1045.pdf