Ventral Hernia RepairNCT07896278
Onlay vs. Sublay Mesh Hernioplasty for Primary Ventral Hernia
A study testing Onlay Mesh Hernioplasty and Sublay Mesh Hernioplasty in people with Ventral Hernia Repair and Hernia Abdominal Wall, run by Provincial Headquarter Teaching Hospital Gilgit at 1 site in Pakistan.
Trial summary
This randomized controlled trial will compare the surgical outcomes of onlay mesh hernioplasty versus sublay mesh hernioplasty in patients with primary ventral wall hernias. The study will assess postoperative pain, seroma formation, hematoma, wound infection, and hernia recurrence over a 6-month follow-up period. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Ventral Hernia Repair, Hernia Abdominal Wall
- What is being tested?
- Onlay Mesh Hernioplasty and Sublay Mesh Hernioplasty
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 sitePakistan
- Study dates
- 11 Aug 2025to 15 Oct 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with primary ventral wall hernia (defect confirmed by ultrasonography, spontaneous occurrence without previous surgical incision at the site) will be included.
- Defect size of hernia between 3 cm and 10 cm (measured through ultrasonography) will be required.
- Patients aged between 20 years and 70 years will be included.
Who cannot join
- Patients with a previous history of abdominal surgery will be excluded.
- Patients with obstructed ventral wall hernia will be excluded.
- Patients with uncontrolled diabetes will be excluded.
- Patients on chronic steroid use will be excluded.
- Patients with anemia (Hemoglobin < 10 g/dL) will be excluded.
- Malnourished patients (serum albumin < 3 mg/dL) will be excluded.
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- Female patients with more than 3 pregnancies will be excluded.
- Patients who do not give informed consent will be excluded.
- Patients with intraoperative complications (e.g., bowel injury) will be excluded.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Provincial Headquarter Teaching Hospital, Gilgit.
Gilgit, Gilgit-Baltistan, 54000
About this study
Official title: Outcomes in Primary Ventral Wall Hernia Repair Using Onlay Mesh Hernioplasty Compared With Sublay Mesh Hernioplasty: A Randomized Controlled Trial
This randomized controlled trial will compare the surgical outcomes of onlay mesh hernioplasty versus sublay mesh hernioplasty in patients with primary ventral wall hernias. The study will assess postoperative pain, seroma formation, hematoma, wound infection, and hernia recurrence over a 6-month follow-up period.
Read the detailed description
Ventral hernia repair is a common surgical procedure, and the use of prosthetic mesh has significantly reduced recurrence rates. However, the optimal plane for mesh placement-onlay (pre-muscular) versus sublay (retro-muscular)-will remain debated. Onlay repair will be simpler and faster to perform, while sublay repair will be considered technically more demanding but may offer better physiological outcomes.
This study will be conducted at PHQ Hospital Gilgit. A total of 76 patients (38 per group) with primary ventral hernias (defect size 3-10 cm) will be randomized using a blocked randomization technique. Group A will undergo onlay mesh hernioplasty, and Group B will undergo sublay mesh hernioplasty. The primary outcomes will include postoperative pain (Visual Analogue Scale), seroma, hematoma, and wound infection. The secondary outcome will be hernia recurrence at 6 months. Data will be analyzed using SPSS version 26.0.
- Conditions
- Ventral Hernia Repair, Hernia Abdominal Wall
- Being tested
- Onlay Mesh Hernioplasty, Sublay Mesh Hernioplasty
- Keywords
- Onlay mesh, Sublay mesh, Hernioplasty, Ventral hernia, Surgical outcomes, Recurrence
- Medical subject headings
- Hernia, Abdominal, Hernia, Ventral, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onlay Mesh HernioplastyProcedure or surgery
Procedure: Onlay Mesh Hernioplasty will be performed.
Sublay Mesh HernioplastyProcedure or surgery
Procedure: Sublay Mesh Hernioplasty will be performed.
| Study group | Role | What they receive |
|---|---|---|
| Onlay Mesh Hernioplasty (Group A) | Experimental | Participants will undergo open ventral hernia repair with mesh placed in the pre-muscular plane (on top of the rectus muscle and beneath the subcutaneous tissue) after tensionless fascial defect closure. The mesh will overlap the defect by 3-5 cm. A drain will be placed in the subcutaneous plane. Receives: Procedure: Onlay Mesh Hernioplasty |
| Sublay Mesh Hernioplasty (Group B) | Active comparator | Participants will undergo open ventral hernia repair with mesh placed in the retro-muscular plane (between the rectus muscle and posterior rectus sheath) after dissection of the hernia sac. The mesh will overlap the defect by at least 5 cm. A drain will be positioned between the posterior rectus sheath and rectus muscle. Receives: Procedure: Sublay Mesh Hernioplasty |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Pain intensity will be measured using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain).
Measured: 12 hours, 4 days. 2 weeks
Seroma Formation
Accumulation of clear, serous fluid at the surgical site will be confirmed by clinical examination or ultrasonography (anechoic/hypoechoic fluid collection).
Measured: Seroma will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Hematoma Formation
Accumulation of blood at the surgical site will be confirmed by clinical examination (bruising, tender swelling) or ultrasonography (complex fluid collection).
Measured: Hematoma will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Wound Infection
Microbial contamination at the surgical site will be characterized by signs of inflammation (hyperemic, painful, hot swelling) with or without purulent discharge, requiring intervention.
Measured: Wound infection will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Recurrence of Hernia
Return of the hernia at the surgical site will be confirmed through clinical and sonological findings.
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 posted26 Oct 2026
- Study start11 Aug 2025
- Primary completion10 Oct 2026
- Study completion15 Oct 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ventral Hernia RepairStudies 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
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Provincial Headquarter Teaching Hospital Gilgit
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Akbar Shah, Provincial Headquarter Teaching Hospital Gilgit
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07896278
- Sponsor's protocol ID
- PHQ02
- Status last verified
- Oct 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared. Data will be kept confidential by the principal investigator under institutional and ethical committee restrictions. The informed consent will not include provisions for external data sharing, and patient privacy will be protected given the small single-center sample. Only aggregate results will be published in a peer-reviewed journal. Data will be stored securely at PHQ Hospital Gilgit for five years.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Outcomes in Primary Ventral Wall Hernia Repair Using Onlay Mesh Hernioplasty Compared With Sublay Mesh Hernioplasty: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07896278
- Acronym / sponsor ID
- PHQ02
- Conditions
- Ventral Hernia Repair, Hernia Abdominal Wall
- Keywords
- Onlay mesh, Sublay mesh, Hernioplasty, Ventral hernia, Surgical outcomes, Recurrence
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Provincial Headquarter Teaching Hospital GilgitUniversity, hospital or other
- Study start
- 11 Aug 2025 (actual)
- Primary completion
- 10 Oct 2026 (actual)
- Study completion
- 15 Oct 2026 (actual)
- First posted
- 26 Oct 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 randomized controlled trial will compare the surgical outcomes of onlay mesh hernioplasty versus sublay mesh hernioplasty in patients with primary ventral wall hernias. The study will assess postoperative pain, seroma formation, hematoma, wound infection, and hernia recurrence over a 6-month follow-up period.
Detailed description
Ventral hernia repair is a common surgical procedure, and the use of prosthetic mesh has significantly reduced recurrence rates. However, the optimal plane for mesh placement-onlay (pre-muscular) versus sublay (retro-muscular)-will remain debated. Onlay repair will be simpler and faster to perform, while sublay repair will be considered technically more demanding but may offer better physiological outcomes.
This study will be conducted at PHQ Hospital Gilgit. A total of 76 patients (38 per group) with primary ventral hernias (defect size 3-10 cm) will be randomized using a blocked randomization technique. Group A will undergo onlay mesh hernioplasty, and Group B will undergo sublay mesh hernioplasty. The primary outcomes will include postoperative pain (Visual Analogue Scale), seroma, hematoma, and wound infection. The secondary outcome will be hernia recurrence at 6 months. Data will be analyzed using SPSS version 26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Onlay Mesh Hernioplasty (Group A) | Experimental | Procedure: Onlay Mesh HernioplastyParticipants will undergo open ventral hernia repair with mesh placed in the pre-muscular plane (on top of the rectus muscle and beneath the subcutaneous tissue) after tensionless fascial defect closure. The mesh will overlap the defect by 3-5 cm. A drain will be placed in the subcutaneous plane. |
| Sublay Mesh Hernioplasty (Group B) | Active comparator | Procedure: Sublay Mesh HernioplastyParticipants will undergo open ventral hernia repair with mesh placed in the retro-muscular plane (between the rectus muscle and posterior rectus sheath) after dissection of the hernia sac. The mesh will overlap the defect by at least 5 cm. A drain will be positioned between the posterior rectus sheath and rectus muscle. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with primary ventral wall hernia (defect confirmed by ultrasonography, spontaneous occurrence without previous surgical incision at the site) will be included.
- Defect size of hernia between 3 cm and 10 cm (measured through ultrasonography) will be required.
- Patients aged between 20 years and 70 years will be included.
Key exclusion criteria (9 listed)
- Patients with a previous history of abdominal surgery will be excluded.
- Patients with obstructed ventral wall hernia will be excluded.
- Patients with uncontrolled diabetes will be excluded.
- Patients on chronic steroid use will be excluded.
- Patients with anemia (Hemoglobin < 10 g/dL) will be excluded.
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 |
|---|---|---|
| Onlay Mesh HernioplastyProcedure: Onlay Mesh Hernioplasty will be performed. | Procedure or surgery | Onlay Mesh Hernioplasty (Group A) |
| Sublay Mesh HernioplastyProcedure: Sublay Mesh Hernioplasty will be performed. | Procedure or surgery | Sublay Mesh Hernioplasty (Group B) |
Primary outcome
Postoperative Pain
Time frame: 12 hours, 4 days. 2 weeks
Pain intensity will be measured using a Visual Analogue Scale (VAS) from 0 (no pain) to 10 (worst pain).
Seroma Formation
Time frame: Seroma will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Accumulation of clear, serous fluid at the surgical site will be confirmed by clinical examination or ultrasonography (anechoic/hypoechoic fluid collection).
Hematoma Formation
Time frame: Hematoma will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Accumulation of blood at the surgical site will be confirmed by clinical examination (bruising, tender swelling) or ultrasonography (complex fluid collection).
Wound Infection
Time frame: Wound infection will be assessed at the 7th and 14th postoperative days, and during follow-up up to 6 months.
Microbial contamination at the surgical site will be characterized by signs of inflammation (hyperemic, painful, hot swelling) with or without purulent discharge, requiring intervention.
Recurrence of Hernia
Time frame: 6 months
Return of the hernia at the surgical site will be confirmed through clinical and sonological findings.
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 26 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared. Data will be kept confidential by the principal investigator under institutional and ethical committee restrictions. The informed consent will not include provisions for external data sharing, and patient privacy will be protected given the small single-center sample. Only aggregate results will be published in a peer-reviewed journal. Data will be stored securely at PHQ Hospital Gilgit for five years.
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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 Onlay Mesh Hernioplasty and Sublay Mesh Hernioplasty in people with Ventral Hernia Repair and Hernia Abdominal Wall, run by Provincial Headquarter Teaching Hospital Gilgit 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 3 inclusion and 9 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 26 Oct 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 (time frame: 12 hours, 4 days. 2 weeks). 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 26 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.