Incisional Hernia, Ventral Hernia
Conditions
Keywords
Sublay Mesh Repair, Onlay Mesh Repair, Polypropylene Mesh, Hernia Surgery, Wound Infection, Seroma Formation, Hernia Recurrence, Randomized Controlled Trial, Open Hernia Repair
Brief 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. 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.
Interventions
PROCEDUREOnlay Mesh Repair
Polypropylene mesh is placed over the anterior rectus sheath and fixed with Prolene sutures after hernia sac reduction.
PROCEDURESublay Mesh Repair
Polypropylene mesh placed in the retrorectus space and fixed with Prolene sutures after Rectus Sheath Dissection
Sponsors
Sana Ehsan ullah
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
This was an open-label study with no masking.
Intervention model description
Participants were randomized into two parallel arms: one receiving onlay mesh repair and the other receiving sublay mesh repair.
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of surgical wound infection | 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 | Within 30 days postoperatively | Seroma defined as subcutaneous fluid accumulation confirmed by clinical exam and ultrasonography. Evaluated during follow-up visits. |
| Hernia recurrence rate | 6-month follow-up | Recurrence assessed through physical examination and confirmed via ultrasonography at 6 months after surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean operative time | Time in minutes from skin incision to skin closure, recorded intraoperatively. | During surgery |
| Length of postoperative hospital stay | From the day of surgery until hospital discharge (average of 3-7 days). | Number of days from surgery to discharge recorded for each participant. |
| Postoperative pain score | At 6 hours, 24 hours, and 48 hours after surgery, and then every 48 hours thereafter until hospital discharge | Pain evaluated using the visual analog scale (VAS) from 0 (no pain) to 10 (worst pain) during inpatient stay. |
Countries
Pakistan
Outcome results
None listed