Inguinal HerniaNCT07261189
Comparing Staples Versus Polypropylene Sutures for Mesh Fixation in Inguinal Hernia Repair in Terms of Postoperative Pain
A study testing Staples for mesh fixation and Polypropylene suture for mesh fixation in people with Inguinal Hernia, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
Trial summary
This randomized controlled trial aims to compare postoperative pain between staples and polypropylene sutures used for mesh fixation in patients undergoing elective Lichtenstein tension-free inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 20 to 60 years, men only
- Conditions the study is for
- Inguinal Hernia
- What is being tested?
- Staples for mesh fixation and Polypropylene suture for mesh fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 168 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2025to 28 Mar 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male patients aged 20 to 60 years.
- Patients undergoing elective Lichtenstein tension-free mesh repair for unilateral, uncomplicated inguinal hernia (direct or indirect).
- Body Mass Index (BMI) between 19 and 30 kg/m².
- ASA physical status I, II, or III.
- Patients willing to participate and provide informed consent.
Who cannot join
- Diabetic patients (on medical records).
- Bilateral or recurrent inguinal hernia.
- Complicated hernia (irreducible, obstructed, or strangulated).
- Patients unwilling to participate or who fail to complete follow-up.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Staples Versus Polypropylene Sutures for Mesh Fixation in Lichenstein's Tension-free Inguinal Hernia Repair in Terms of Postoperative Pain
This randomized controlled trial aims to compare postoperative pain between staples and polypropylene sutures used for mesh fixation in patients undergoing elective Lichtenstein tension-free inguinal hernia repair.
Read the detailed description
Inguinal hernia repair is one of the most common general surgical procedures worldwide. The standard method for mesh fixation during Lichtenstein tension-free hernioplasty uses polypropylene sutures. However, skin staples have recently been introduced as a faster and potentially less painful alternative. This randomized controlled trial compares both methods in terms of postoperative pain, measured using the Visual Analogue Scale (VAS), and operative time.
- Conditions
- Inguinal Hernia
- Being tested
- Staples for mesh fixation, Polypropylene suture for mesh fixation
- Keywords
- Lichensteins repair, staples, polypropylene sutures, mesh fixation, postoperative pain, hernioplasty
- Medical subject headings
- Hernia, Inguinal, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Staples for mesh fixationProcedure or surgery
Mesh secured using stainless steel staples in Lichenstein tension-free inguinal hernioplasty
Polypropylene suture for mesh fixationProcedure or surgery
Mesh secured using polypropylene sutures in Lichenstein tension-free inguinal hernioplasty
| Study group | Role | What they receive |
|---|---|---|
| Staples for mesh fixation | Experimental | Mesh secured with stainless steel staples during Lichenstein tension-free inguinal hernioplasty Receives: Procedure: Staples for mesh fixation |
| Polypropylene Suture Group | Active comparator | Mesh secured with polypropylene sutures during Lichensteins tension-free inguinal hernioplasty Receives: Procedure: Polypropylene suture for mesh fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain (VAS score)
Pain intensity will be measured using the Visual Analogue Scale (VAS 0-10)
Measured: Postoperative day 1, day 7 and day 30
Secondary outcomes (1)
Operative time (minutes)
Time in minutes from initiation of mesh fixation to completion of skin closure
Measured: During Surgery (intraoperative period)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start1 Sep 2025
- Primary completion28 Feb 2026
- Study completion28 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal HerniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jinnah Postgraduate Medical Centre
- Sponsor type
- Other government
- Collaborators
- College of Physicians and Surgeons Pakistan
- Responsible party
- Principal investigator, Asna Ursani, Jinnah Postgraduate Medical Centre
- Investigators
- Shafqatullah, Principal investigator, Jinnah Postgraduate Medical Centre, Karachi, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07261189
- Sponsor's protocol ID
- JPMC-GS-2025-12507
- Status last verified
- Apr 2026
- First submitted
- 21 Nov 2025
- Last updated
- 7 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will not share individual participant data. Only aggregated results will be published. Data will remain confidential as per institutional policy and ethical approval requirements
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Staples Versus Polypropylene Sutures for Mesh Fixation in Lichenstein's Tension-free Inguinal Hernia Repair in Terms of Postoperative Pain
- ClinicalTrials.gov ID
- NCT07261189
- Acronym / sponsor ID
- JPMC-GS-2025-12507
- Conditions
- Inguinal Hernia
- Keywords
- Lichensteins repair, staples, polypropylene sutures, mesh fixation, postoperative pain, hernioplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- Jinnah Postgraduate Medical CentreOther government
- Collaborators
- College of Physicians and Surgeons Pakistan
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Mar 2026 (actual)
- First posted
- 3 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomized controlled trial aims to compare postoperative pain between staples and polypropylene sutures used for mesh fixation in patients undergoing elective Lichtenstein tension-free inguinal hernia repair.
Detailed description
Inguinal hernia repair is one of the most common general surgical procedures worldwide. The standard method for mesh fixation during Lichtenstein tension-free hernioplasty uses polypropylene sutures. However, skin staples have recently been introduced as a faster and potentially less painful alternative. This randomized controlled trial compares both methods in terms of postoperative pain, measured using the Visual Analogue Scale (VAS), and operative time.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Staples for mesh fixation | Experimental | Procedure: Staples for mesh fixationMesh secured with stainless steel staples during Lichenstein tension-free inguinal hernioplasty |
| Polypropylene Suture Group | Active comparator | Procedure: Polypropylene suture for mesh fixationMesh secured with polypropylene sutures during Lichensteins tension-free inguinal hernioplasty |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male patients aged 20 to 60 years.
- Patients undergoing elective Lichtenstein tension-free mesh repair for unilateral, uncomplicated inguinal hernia (direct or indirect).
- Body Mass Index (BMI) between 19 and 30 kg/m².
- ASA physical status I, II, or III.
- Patients willing to participate and provide informed consent.
Key exclusion criteria (4 listed)
- Diabetic patients (on medical records).
- Bilateral or recurrent inguinal hernia.
- Complicated hernia (irreducible, obstructed, or strangulated).
- Patients unwilling to participate or who fail to complete follow-up.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Staples for mesh fixationMesh secured using stainless steel staples in Lichenstein tension-free inguinal hernioplasty | Procedure or surgery | Staples for mesh fixation |
| Polypropylene suture for mesh fixationMesh secured using polypropylene sutures in Lichenstein tension-free inguinal hernioplasty | Procedure or surgery | Polypropylene Suture Group |
Primary outcome
Postoperative pain (VAS score)
Time frame: Postoperative day 1, day 7 and day 30
Pain intensity will be measured using the Visual Analogue Scale (VAS 0-10)
1 secondary outcome
Operative time (minutes)
Time frame: During Surgery (intraoperative period)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2026.
- Individual participant dataSharing planned: No. This study will not share individual participant data. Only aggregated results will be published. Data will remain confidential as per institutional policy and ethical approval requirements
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shafqatullah principal investigator
Jinnah Postgraduate Medical Centre, Karachi, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Staples for mesh fixation and Polypropylene suture for mesh fixation in people with Inguinal Hernia, run by Jinnah Postgraduate Medical Centre at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain (VAS score) (time frame: Postoperative day 1, day 7 and day 30). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2026.