Inguinal Hernia UnilateralNCT07627425
STAPLES VERSUS SUTURES FOR MESH FIXATION IN LICHTENSTEIN HERNIOPLASTY: A RANDOMIZED CONTROLLED TRIAL EVALUATING POSTOPERATIVE OUTCOMES IN INGUINAL HERNIA PATIENTS
A study testing Mesh fixation with Staples and Mesh Fixation with Sutures in people with Inguinal Hernia Unilateral, run by Huzaif Saeed Khan at 1 site in Pakistan.
Trial summary
The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair. Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- Conditions the study is for
- Inguinal Hernia Unilateral
- What is being tested?
- Mesh fixation with Staples and Mesh Fixation with Sutures
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 sitePakistan
- Study dates
- 21 Mar 2026to 21 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult male patients aged 18-75 years with uncomplicated unilateral inguinal hernia undergoing elective open Lichtenstein mesh repair
Who cannot join
- Recurrent hernias
- ASA (American Society of Anaesthesiologists) class III or greater
- Patients with active obstructive lower urinary tract symptoms
- Accidental per-operative nerve injury
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair.
Read the detailed description
The two techniques of mesh fixation include sutures and staples.
- Conditions
- Inguinal Hernia Unilateral
- Being tested
- Mesh fixation with Staples, Mesh Fixation with Sutures
- Keywords
- Lichtenstein, inguinal hernia repair, mesh fixation, postoperative pain, inguinodynia, surgical site infection, visual analogue scale
- Medical subject headings
- Pain, Postoperative, Surgical Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesh fixation with StaplesProcedure or surgery
2 staples will be applied directly over the pubic tubercle, while 3-4 staples will be used to fix the mesh over the inguinal ligament 1-2cm apart. Another 2-3 staples will secure the mesh to the conjoint tendon, and 1 staple lateral to the cord at the deep ring.
Mesh Fixation with SuturesProcedure or surgery
Polypropylene sutures will be used to fix the mesh, with continuous suturing over the pubic tubercle and inguinal ligament, and interrupted suturing along the posterior wall and deep ring.
| Study group | Role | What they receive |
|---|---|---|
| Mesh fixation with staples | Experimental | Not described Receives: Procedure: Mesh fixation with Staples |
| Mesh fixation with sutures | Active comparator | Not described Receives: Procedure: Mesh Fixation with Sutures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inguinodynia
Will be assessed through a visual analogue scale (VAS), where zero is equivalent to no pain and 10 indicates the worst possible pain.
Measured: 3 and 6 months postoperatively
Surgical site infection
Assessed using Southampton Surgical Site Infection grading system
Measured: within 30 days of surgery
Wound Hematoma
Collection of blood at the surgical site presenting as painful swelling with discoloration, confirmed clinically
Measured: Within 30 days postoperatively
Wound Seroma
Collection of clear fluid at the operative site, diagnosed clinically as a fluctuant, non-tender swelling at the surgical site
Measured: within 30 days postoperatively
Scrotal edema/hematoma
Swelling or collection of fluid/blood in the scrotum, identified clinically
Measured: within 30 days postoperatively
Secondary outcomes (2)
Hernia recurrence
Clinically apparent swelling/bulge in the groin, diagnosed by clinical assessment, at the previously operated site
Measured: Within 6 months of surgery.
Operative time
Time in minutes from skin incision to completion of skin closure
Measured: During procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start21 Mar 2026
- Primary completion21 Sep 2026 (estimated)
- Study completion21 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inguinal Hernia UnilateralStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Huzaif Saeed Khan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Huzaif Saeed Khan, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07627425
- Sponsor's protocol ID
- SIUT-ERC-2025/A-582
- Status last verified
- May 2026
- First submitted
- 30 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- STAPLES VERSUS SUTURES FOR MESH FIXATION IN LICHTENSTEIN HERNIOPLASTY: A RANDOMIZED CONTROLLED TRIAL EVALUATING POSTOPERATIVE OUTCOMES IN INGUINAL HERNIA PATIENTS
- ClinicalTrials.gov ID
- NCT07627425
- Acronym / sponsor ID
- SIUT-ERC-2025/A-582
- Conditions
- Inguinal Hernia Unilateral
- Keywords
- Lichtenstein, inguinal hernia repair, mesh fixation, postoperative pain, inguinodynia, surgical site infection, visual analogue scale
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Huzaif Saeed KhanUniversity, hospital or other
- Study start
- 21 Mar 2026 (actual)
- Primary completion
- 21 Sep 2026 (estimated)
- Study completion
- 21 Mar 2027 (estimated)
- First posted
- 4 Jun 2026 (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.
The study is aimed at comparing postoperative complications between two different techniques of mesh fixation in lichtenstein inguinal hernia repair.
Detailed description
The two techniques of mesh fixation include sutures and staples.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesh fixation with staples | Experimental | Procedure: Mesh fixation with Staples |
| Mesh fixation with sutures | Active comparator | Procedure: Mesh Fixation with Sutures |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male patients aged 18-75 years with uncomplicated unilateral inguinal hernia undergoing elective open Lichtenstein mesh repair
Key exclusion criteria (4 listed)
- Recurrent hernias
- ASA (American Society of Anaesthesiologists) class III or greater
- Patients with active obstructive lower urinary tract symptoms
- Accidental per-operative nerve injury
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 |
|---|---|---|
| Mesh fixation with Staples2 staples will be applied directly over the pubic tubercle, while 3-4 staples will be used to fix the mesh over the inguinal ligament 1-2cm apart. Another 2-3 staples will secure the mesh to the conjoint tendon, and 1 staple lateral to the cord at the deep ring. | Procedure or surgery | Mesh fixation with staples |
| Mesh Fixation with SuturesPolypropylene sutures will be used to fix the mesh, with continuous suturing over the pubic tubercle and inguinal ligament, and interrupted suturing along the posterior wall and deep ring. | Procedure or surgery | Mesh fixation with sutures |
Primary outcome
Inguinodynia
Time frame: 3 and 6 months postoperatively
Will be assessed through a visual analogue scale (VAS), where zero is equivalent to no pain and 10 indicates the worst possible pain.
Surgical site infection
Time frame: within 30 days of surgery
Assessed using Southampton Surgical Site Infection grading system
Wound Hematoma
Time frame: Within 30 days postoperatively
Collection of blood at the surgical site presenting as painful swelling with discoloration, confirmed clinically
Wound Seroma
Time frame: within 30 days postoperatively
Collection of clear fluid at the operative site, diagnosed clinically as a fluctuant, non-tender swelling at the surgical site
Scrotal edema/hematoma
Time frame: within 30 days postoperatively
Swelling or collection of fluid/blood in the scrotum, identified clinically
2 secondary outcomes
Hernia recurrence
Time frame: Within 6 months of surgery.
Operative time
Time frame: During procedure
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: No
Related trials for Inguinal Hernia Unilateral
Recruiting
Watchful Waiting Versus Immediate Repair for Occult Contralateral Inguinal Hernias.
Inguinal Hernia Bilateral, Inguinal Hernia Unilateral
Recruiting
Desarda Tissue Technique vs Lichtenstein Technique for Primary Inguinal Hernia Repair
Inguinal Hernia Unilateral, Complications of Surgical Procedures or Medical Care
Not yet recruiting
Quadro-Iliac Plane Block for Postoperative Analgesia in Laparoscopic Inguinal Hernia Repair
Inguinal Hernia Unilateral, Postoperative Pain
Not yet recruitingObservational study
Comparison of Quadro-Iliac Plane Block and Transversalis Fascia Plane Block for Open Inguinal Hernia Repair
Inguinal Hernia Unilateral
RecruitingPhase 1
Reversing InGuinal Hernia Trial: The Evaluation of Sex Hormones to Reverse Inguinal Hernias in Males
Inguinal Hernia Unilateral, Inguinal Hernia Bilateral
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mesh fixation with Staples and Mesh Fixation with Sutures in people with Inguinal Hernia Unilateral, run by Huzaif Saeed Khan 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 1 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: enrolling by invitation, as of the sponsor's last update on 4 Jun 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?
This study is still under way. Results are not available in the source record yet.
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?
Inguinodynia (time frame: 3 and 6 months postoperatively). The study lists 5 primary outcomes in all. 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 4 Jun 2026.