İnguinal HerniaCOMETNCT07334548
Post-Surgical Outcomes of Conventional vs 3-Point Mesh Fixation in Lichtenstein Repair: An RCT
A study testing 3-point mesh fixation and Conventional Mesh Fixation in people with İnguinal Hernia and Complication,Postoperative, run by Sahar Mughis at 1 site in Pakistan.
Trial summary
This is a single-center, parallel-group randomized controlled trial conducted in 2025-2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- İnguinal Hernia, Complication,Postoperative, Pain, Postoperative
- What is being tested?
- 3-point mesh fixation and Conventional Mesh Fixation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Sep 2025to 28 Feb 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients presenting to the outpatient department with unilateral inguinal hernia requiring Lichtenstein repair
- Age between 18-70 years Both male and female ASA I-II
Who cannot join
- Recurrent, bilateral, complicated, or incisional hernia Patients with pre-existing obstructive LUTS Chronic kidney disease (CKD), patients on hemodyalysis. Chronic liver disease (CLD)
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Sindh Institute of Urology and Transplantation
Karachi, Sindh, 74200
About this study
Official title: A Comparative Analysis of Polypropylene Conventional Mesh Fixation Versus 3-point Fixation Technique to Assess Post-Surgical Outcomes in Lichtenstein Hernia Repair (RCT).
This is a single-center, parallel-group randomized controlled trial conducted in 2025-2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. This study shows the comparative analysis of polypropylene conventional mesh fixation versus 3-point fixation technique to assess Post-Surgical Outcomes in Lichtenstein Hernia Repair
Read the detailed description
This randomized controlled trial is designed to compare the outcomes of conventional mesh fixation versus 3-point fixation in patients undergoing Lichtenstein inguinal hernia repair. The primary focus is to evaluate immediate postoperative outcomes-pain, seroma, hematoma, and wound infection-on postoperative days 1 and 7. Long-term outcomes, including recurrence and chronic groin pain, will be assessed at 3 months and 6 months. The study will include 64 patients aged 18-70 years, meeting ASA I-II criteria, and presenting with unilateral inguinal hernia. They will be randomly assigned to one of the two fixation techniques under a single-blind design where only the patient is blinded.
Data will be collected using a structured proforma capturing demographics, perioperative findings, and postoperative follow-up information. Pain will be measured using the Visual Analog Scale (VAS) with standardized analgesia. Data analysis will be performed using SPSS, with appropriate statistical tests applied according to the nature of the variables. A significance level of p < 0.05 will be used.
- Being tested
- 3-point mesh fixation, Conventional Mesh Fixation
- Keywords
- comparision, lichtenstein mesh repair, 3-point fixation, inguinal hernia
- Medical subject headings
- Hernia, Inguinal, Postoperative Complications, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3-point mesh fixationProcedure or surgery
Patients in this group will undergo Lichtenstein hernia repair with polypropylene mesh fixed at three key points only (pubic tubercle, inguinal ligament and conjoint tendon). The fixation points will be strategically chosen to provide sufficient stability while minimizing tissue trauma.
Rationale: Reducing the number of fixation points is expected to decrease the risk of nerve entrapment, muscle irritation, and post-operative pain, without compromising mesh position or increasing recurrence rates
Conventional Mesh FixationProcedure or surgery
Patients in this group will undergo Lichtenstein tension-free hernia repair using a polypropylene mesh secured with the conventional technique. Multiple non-absorbable sutures will be placed across the inguinal floor to anchor the mesh between the transversalis fascia and the external oblique aponeurosis
| Study group | Role | What they receive |
|---|---|---|
| Conventional Mesh Fixation Group (Standard Fixation | Active comparator | Lichtenstein inguinal hernia repair with polypropylene mesh fixed using the conventional technique (multiple non-absorbable sutures across the inguinal floor) to measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up) Receives: Procedure: Conventional Mesh Fixation |
| 3-Point Mesh Fixation Group (Minimal Fixation) | Experimental | Lichtenstein inguinal hernia repair with polypropylene mesh fixed at only three strategic points to minimize tissue trauma. To measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up) Receives: Procedure: 3-point mesh fixation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute post operative pain
Acute Postoperative pain measured using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable).
Standard analgesia (ketorolac 30 mg twice daily) will be provided.
Measured: 7 days
wound infection
Defined according to CDC criteria: redness, warmth, discharge, or systemic signs of infection at the incision site
Measured: 7- 14 days
Seroma
The fluid collection at the surgical site which will be confirmed clinically or by ultrasound if needed.
Measured: 7-14 days
hematoma
A localized collection of blood at the operative site which will be assessed clinically for swelling, discoloration, and need for intervention.
Measured: 7 days
Secondary outcomes (2)
Chronic groin pain
Pain persisting beyond three months post-surgery, measured using VAS and patient-reported impact on daily activities.
Severity categorized as mild, moderate, or severe.
Measured: 6 months
Hernia recurrence
Recurrence of previously repaired inguinal sweling/hernia clinically diagnosed by physical examination and confirmed with ultrasound.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2026
- Study start15 Sep 2025
- Primary completion28 Feb 2026
- Study completion28 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for İnguinal 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
- None (open label)
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahar Mughis
- Sponsor type
- University, hospital or other
- Collaborators
- Sindh Institute of Urology and Transplantation
- Responsible party
- Sponsor-investigator, Sahar Mughis, Sindh Institute of Urology and Transplantation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07334548
- Sponsor's protocol ID
- SIUT-ERC-2025/A-573
- Acronym
- COMET
- Status last verified
- Dec 2025
- First submitted
- 3 Jan 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- 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
- A Comparative Analysis of Polypropylene Conventional Mesh Fixation Versus 3-point Fixation Technique to Assess Post-Surgical Outcomes in Lichtenstein Hernia Repair (RCT).
- ClinicalTrials.gov ID
- NCT07334548
- Acronym / sponsor ID
- COMET / SIUT-ERC-2025/A-573
- Keywords
- comparision, lichtenstein mesh repair, 3-point fixation, inguinal hernia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Sahar MughisUniversity, hospital or other
- Collaborators
- Sindh Institute of Urology and Transplantation
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- 28 Feb 2026 (actual)
- Study completion
- 28 Feb 2026 (actual)
- First posted
- 12 Jan 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.
This is a single-center, parallel-group randomized controlled trial conducted in 2025-2025 at the General Surgery Ward of the Sindh Institute of Urology and Transplantation (SIUT), Karachi. This study shows the comparative analysis of polypropylene conventional mesh fixation versus 3-point fixation technique to assess Post-Surgical Outcomes in Lichtenstein Hernia Repair
Detailed description
This randomized controlled trial is designed to compare the outcomes of conventional mesh fixation versus 3-point fixation in patients undergoing Lichtenstein inguinal hernia repair. The primary focus is to evaluate immediate postoperative outcomes-pain, seroma, hematoma, and wound infection-on postoperative days 1 and 7. Long-term outcomes, including recurrence and chronic groin pain, will be assessed at 3 months and 6 months. The study will include 64 patients aged 18-70 years, meeting ASA I-II criteria, and presenting with unilateral inguinal hernia. They will be randomly assigned to one of the two fixation techniques under a single-blind design where only the patient is blinded.
Data will be collected using a structured proforma capturing demographics, perioperative findings, and postoperative follow-up information. Pain will be measured using the Visual Analog Scale (VAS) with standardized analgesia. Data analysis will be performed using SPSS, with appropriate statistical tests applied according to the nature of the variables. A significance level of p < 0.05 will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional Mesh Fixation Group (Standard Fixation | Active comparator | Procedure: Conventional Mesh FixationLichtenstein inguinal hernia repair with polypropylene mesh fixed using the conventional technique (multiple non-absorbable sutures across the inguinal floor) to measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up) |
| 3-Point Mesh Fixation Group (Minimal Fixation) | Experimental | Procedure: 3-point mesh fixationLichtenstein inguinal hernia repair with polypropylene mesh fixed at only three strategic points to minimize tissue trauma. To measure Immediate postoperative complications: seroma, hematoma, wound infection, acute pain (post-op days 1 and 7) and long-term outcomes: chronic groin pain (CGP) and hernia recurrence (3 months and 6 months follow-up) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients presenting to the outpatient department with unilateral inguinal hernia requiring Lichtenstein repair
- Age between 18-70 years Both male and female ASA I-II
Key exclusion criteria (1 listed)
- Recurrent, bilateral, complicated, or incisional hernia Patients with pre-existing obstructive LUTS Chronic kidney disease (CKD), patients on hemodyalysis. Chronic liver disease (CLD)
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 |
|---|---|---|
| 3-point mesh fixationPatients in this group will undergo Lichtenstein hernia repair with polypropylene mesh fixed at three key points only (pubic tubercle, inguinal ligament and conjoint tendon). The fixation points will be strategically chosen to provide sufficient stability while minimizing tissue trauma. Rationale: Reducing the number of fixation points is expected to decrease the risk of nerve entrapment, muscle irritation, and post-operative pain, without compromising mesh position or increasing recurrence rates | Procedure or surgery | 3-Point Mesh Fixation Group (Minimal Fixation) |
| Conventional Mesh FixationPatients in this group will undergo Lichtenstein tension-free hernia repair using a polypropylene mesh secured with the conventional technique. Multiple non-absorbable sutures will be placed across the inguinal floor to anchor the mesh between the transversalis fascia and the external oblique aponeurosis | Procedure or surgery | Conventional Mesh Fixation Group (Standard Fixation |
Primary outcome
Acute post operative pain
Time frame: 7 days
Acute Postoperative pain measured using the Visual Analog Scale (VAS), with scores ranging from 0 (no pain) to 10 (worst pain imaginable). Standard analgesia (ketorolac 30 mg twice daily) will be provided.
wound infection
Time frame: 7- 14 days
Defined according to CDC criteria: redness, warmth, discharge, or systemic signs of infection at the incision site
Seroma
Time frame: 7-14 days
The fluid collection at the surgical site which will be confirmed clinically or by ultrasound if needed.
hematoma
Time frame: 7 days
A localized collection of blood at the operative site which will be assessed clinically for swelling, discoloration, and need for intervention.
2 secondary outcomes
Chronic groin pain
Time frame: 6 months
Hernia recurrence
Time frame: 6 months
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 4 Jun 2026.
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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.
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 3-point mesh fixation and Conventional Mesh Fixation in people with İnguinal Hernia and Complication,Postoperative, run by Sahar Mughis 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 2 inclusion and 1 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 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?
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?
Acute post operative pain (time frame: 7 days). The study lists 4 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.