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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Sublay Mesh Repair | Experimental | Participants underwent sublay mesh repair, where the polypropylene mesh was placed in the retrorectus space after posterior sheath dissection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Onlay Mesh Repair | Procedure | Polypropylene mesh is placed over the anterior rectus sheath and fixed with Prolene sutures after hernia sac reduction. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | Within 30 days postoperatively |
| Hernia recurrence rate | Recurrence assessed through physical examination and confirmed via ultrasonography at 6 months after surgery. | 6-month follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| Mean operative time | During surgery | 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. |
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Inclusion Criteria:
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
Exclusion Criteria:
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
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Recep Tayyip Erdogan Hospital | Muzaffargarh | Punjab Province | 34200 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42170404 | Derived | 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. |
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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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| ID | Term |
|---|---|
| D006555 | Hernia, Ventral |
| D000069290 | Incisional Hernia |
| D014946 | Wound Infection |
| ID | Term |
|---|---|
| D046449 | Hernia, Abdominal |
| D006547 | Hernia |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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Participants were randomized into two parallel arms: one receiving onlay mesh repair and the other receiving sublay mesh repair.
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This was an open-label study with no masking.
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| Sublay Mesh Repair | Procedure | Polypropylene mesh placed in the retrorectus space and fixed with Prolene sutures after Rectus Sheath Dissection |
|
| 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. | At 6 hours, 24 hours, and 48 hours after surgery, and then every 48 hours thereafter until hospital discharge |
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D007239 | Infections |