Ventral HerniaNCT07140471
Comparison of Sublay and Onlay Mesh Repair in Ventral Hernia
A study testing Onlay Mesh Repair and Sublay Mesh Repair in people with Ventral Hernia and Incisional Hernia, run by Sana Ehsan ullah at 1 site in Pakistan.
Trial summary
This study is designed to compare two different surgical methods for repairing ventral abdominal wall hernias: sublay mesh repair and onlay mesh repair. Ventral hernias are common and occur when tissue pushes through a weak spot in the abdominal wall. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ventral Hernia, Incisional Hernia
- What is being tested?
- Onlay Mesh Repair and Sublay Mesh Repair
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Feb 2022to 28 Aug 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 60 years
- Primary or incisional ventral abdominal wall hernia
- Hernia defect size between 40-100 mm
- Duration of hernia ≥6 months
- Suitable for open mesh hernioplasty
- Written informed consent provided
Who cannot join
- Diabetes mellitus >5 years
- Chronic liver disease
- Obstructed or strangulated hernia
- Immunocompromised status
- Severe cardiopulmonary disease or contraindications to general anesthesia
- Pregnant or lactating women
- Inability to attend follow-up visits
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Recep Tayyip Erdogan Hospital
Muzaffargarh, Punjab Province, 34200
About this study
Official title: Comparison of Sublay Versus Onlay Mesh Repair for Ventral Abdominal Wall Hernia: A Randomized Controlled Trial
This study is designed to compare two different surgical methods for repairing ventral abdominal wall hernias: sublay mesh repair and onlay mesh repair. Ventral hernias are common and occur when tissue pushes through a weak spot in the abdominal wall. Both sublay and onlay techniques involve placing a synthetic mesh to strengthen the abdominal wall, but the position of the mesh differs. This trial will evaluate postoperative outcomes, including surgical wound infections, seroma (fluid buildup), and hernia recurrence, over a six-month follow-up period. The findings are expected to help inform surgical decision-making, particularly in resource-limited hospitals.
Read the detailed description
This prospective, open-label, randomized controlled trial aims to compare outcomes between sublay and onlay mesh repair techniques in patients with ventral abdominal wall hernias. The study is being conducted at Recep Tayyip Erdogan Hospital, Muzaffargarh, Pakistan, from February 2022 to August 2023. A total of 96 patients aged 18-60 years with primary or incisional ventral hernias (defect size 40-100 mm) are included. Patients are randomized into two groups: Group A undergoes onlay mesh repair, and Group B undergoes sublay mesh repair. Both procedures involve placement of macroporous polypropylene mesh with appropriate overlap and standard fixation techniques.
Primary outcomes include wound infection (as per CDC criteria), seroma formation (confirmed by ultrasound), and hernia recurrence (clinically and via ultrasonography) at six-month follow-up. Secondary outcomes include operative time, postoperative pain (measured via visual analog scale), and hospital stay duration. Data analysis will be performed using SPSS v26.0.
- Conditions
- Ventral Hernia, Incisional Hernia
- Being tested
- Onlay Mesh Repair, Sublay Mesh Repair
- Keywords
- Sublay Mesh Repair, Onlay Mesh Repair, Polypropylene Mesh, Hernia Surgery, Wound Infection, Seroma Formation, Hernia Recurrence, Randomized Controlled Trial, Open Hernia Repair
- Medical subject headings
- Hernia, Ventral, Incisional Hernia, Wound Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onlay Mesh RepairProcedure or surgery
Polypropylene mesh is placed over the anterior rectus sheath and fixed with Prolene sutures after hernia sac reduction.
Sublay Mesh RepairProcedure or surgery
Polypropylene mesh placed in the retrorectus space and fixed with Prolene sutures after Rectus Sheath Dissection
| Study group | Role | What they receive |
|---|---|---|
| Onlay Mesh Repair | Active comparator | Participants underwent onlay mesh repair, where the polypropylene mesh was placed over the anterior rectus sheath after hernia reduction and defect closure. Receives: Procedure: Onlay Mesh Repair |
| Sublay Mesh Repair | Experimental | Participants underwent sublay mesh repair, where the polypropylene mesh was placed in the retrorectus space after posterior sheath dissection. Receives: Procedure: Sublay Mesh Repair |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of surgical wound infection
Wound infection was assessed based on CDC criteria: fever >38°C, erythema, purulent discharge, or swelling at the surgical site. Evaluated daily during hospitalization and at 2-week follow-up.
Measured: Within 30 days after surgery
Incidence of seroma formation
Seroma defined as subcutaneous fluid accumulation confirmed by clinical exam and ultrasonography. Evaluated during follow-up visits.
Measured: Within 30 days postoperatively
Hernia recurrence rate
Recurrence assessed through physical examination and confirmed via ultrasonography at 6 months after surgery.
Measured: 6-month follow-up
Secondary outcomes (3)
Mean operative time
During surgery
Measured: Time in minutes from skin incision to skin closure, recorded intraoperatively.
Length of postoperative hospital stay
Number of days from surgery to discharge recorded for each participant.
Measured: From the day of surgery until hospital discharge (average of 3-7 days).
Postoperative pain score
Pain evaluated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain) during inpatient stay.
Measured: At 6 hours, 24 hours, and 48 hours after surgery, and then every 48 hours thereafter until hospital discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2025
- Study start1 Feb 2022
- Primary completion28 Aug 2023
- Study completion28 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ventral 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
- Model description
- Participants were randomized into two parallel arms: one receiving onlay mesh repair and the other receiving sublay mesh repair.
- Masking
- None (open label)
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sana Ehsan ullah
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sana Ehsan ullah, Recep Tayyip Erdogan Hospital Pakistan - Muzaffargarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07140471
- Sponsor's protocol ID
- IHHN_IRB_2023_05_026
- Status last verified
- Aug 2025
- First submitted
- 6 Aug 2025
- Last updated
- 24 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Individual participant data (IPD) will not be shared due to privacy concerns, institutional policy, and the absence of specific data-sharing agreements or infrastructure for secure dissemination.
Publications
Ullah SE, Hussain MI, Javed I. A randomized controlled comparison of sublay and onlay mesh techniques in ventral abdominal wall hernia repair. Pak J Med Sci. 2026 Apr;42(4ICON Suppl):S26-S30. doi: 10.12669/pjms.42.(ICON26).15688.
PubMed 42170404
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sublay Versus Onlay Mesh Repair for Ventral Abdominal Wall Hernia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07140471
- Acronym / sponsor ID
- IHHN_IRB_2023_05_026
- Conditions
- Ventral Hernia, Incisional Hernia
- Keywords
- Sublay Mesh Repair, Onlay Mesh Repair, Polypropylene Mesh, Hernia Surgery, Wound Infection, Seroma Formation, Hernia Recurrence, Randomized Controlled Trial
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Sana Ehsan ullahUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 28 Aug 2023 (actual)
- Study completion
- 28 Aug 2023 (actual)
- First posted
- 24 Aug 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 study is designed to compare two different surgical methods for repairing ventral abdominal wall hernias: sublay mesh repair and onlay mesh repair. Ventral hernias are common and occur when tissue pushes through a weak spot in the abdominal wall. Both sublay and onlay techniques involve placing a synthetic mesh to strengthen the abdominal wall, but the position of the mesh differs. This trial will evaluate postoperative outcomes, including surgical wound infections, seroma (fluid buildup), and hernia recurrence, over a six-month follow-up period. The findings are expected to help inform surgical decision-making, particularly in resource-limited hospitals.
Detailed description
This prospective, open-label, randomized controlled trial aims to compare outcomes between sublay and onlay mesh repair techniques in patients with ventral abdominal wall hernias. The study is being conducted at Recep Tayyip Erdogan Hospital, Muzaffargarh, Pakistan, from February 2022 to August 2023. A total of 96 patients aged 18-60 years with primary or incisional ventral hernias (defect size 40-100 mm) are included. Patients are randomized into two groups: Group A undergoes onlay mesh repair, and Group B undergoes sublay mesh repair. Both procedures involve placement of macroporous polypropylene mesh with appropriate overlap and standard fixation techniques.
Primary outcomes include wound infection (as per CDC criteria), seroma formation (confirmed by ultrasound), and hernia recurrence (clinically and via ultrasonography) at six-month follow-up. Secondary outcomes include operative time, postoperative pain (measured via visual analog scale), and hospital stay duration. Data analysis will be performed using SPSS v26.0.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants were randomized into two parallel arms: one receiving onlay mesh repair and the other receiving sublay mesh repair.
| Arm | Type | Receives |
|---|---|---|
| Onlay Mesh Repair | Active comparator | Procedure: Onlay Mesh RepairParticipants underwent onlay mesh repair, where the polypropylene mesh was placed over the anterior rectus sheath after hernia reduction and defect closure. |
| Sublay Mesh Repair | Experimental | Procedure: Sublay Mesh RepairParticipants underwent sublay mesh repair, where the polypropylene mesh was placed in the retrorectus space after posterior sheath dissection. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age 18 to 60 years
- Primary or incisional ventral abdominal wall hernia
- Hernia defect size between 40-100 mm
- Duration of hernia ≥6 months
- Suitable for open mesh hernioplasty
Key exclusion criteria (7 listed)
- Diabetes mellitus >5 years
- Chronic liver disease
- Obstructed or strangulated hernia
- Immunocompromised status
- Severe cardiopulmonary disease or contraindications to general anesthesia
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 RepairPolypropylene mesh is placed over the anterior rectus sheath and fixed with Prolene sutures after hernia sac reduction. | Procedure or surgery | Onlay Mesh Repair |
| Sublay Mesh RepairPolypropylene mesh placed in the retrorectus space and fixed with Prolene sutures after Rectus Sheath Dissection | Procedure or surgery | Sublay Mesh Repair |
Primary outcome
Incidence of surgical wound infection
Time frame: Within 30 days after surgery
Wound infection was assessed based on CDC criteria: fever >38°C, erythema, purulent discharge, or swelling at the surgical site. Evaluated daily during hospitalization and at 2-week follow-up.
Incidence of seroma formation
Time frame: Within 30 days postoperatively
Seroma defined as subcutaneous fluid accumulation confirmed by clinical exam and ultrasonography. Evaluated during follow-up visits.
Hernia recurrence rate
Time frame: 6-month follow-up
Recurrence assessed through physical examination and confirmed via ultrasonography at 6 months after surgery.
3 secondary outcomes
Mean operative time
Time frame: Time in minutes from skin incision to skin closure, recorded intraoperatively.
Length of postoperative hospital stay
Time frame: From the day of surgery until hospital discharge (average of 3-7 days).
Postoperative pain score
Time frame: At 6 hours, 24 hours, and 48 hours after surgery, and then every 48 hours thereafter until hospital discharge
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 24 Aug 2025.
- Derived from this study: PubMed 42170404Ullah SE, Hussain MI, Javed I. A randomized controlled comparison of sublay and onlay mesh techniques in ventral abdominal wall hernia repair. Pak J Med Sci. 2026 Apr;42(4ICON Suppl):S26-S30. doi: 10.12669/pjms.42.(ICON26).15688.
- Individual participant dataSharing planned: Undecided. Individual participant data (IPD) will not be shared due to privacy concerns, institutional policy, and the absence of specific data-sharing agreements or infrastructure for secure dissemination.
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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 Repair and Sublay Mesh Repair in people with Ventral Hernia and Incisional Hernia, run by Sana Ehsan ullah 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 6 inclusion and 7 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 24 Aug 2025. 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?
Incidence of surgical wound infection (time frame: Within 30 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07140471, which also lists 1 linked publication.
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 24 Aug 2025.